topic
stringlengths 245
1.29k
| doc
stringlengths 52
16.9k
| label
stringclasses 3
values |
|---|---|---|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 1.0-30.0, Acute Lymphoblastic Leukemia Adult B Lymphoblastic Lymphoma Ann Arbor Stage I B Lymphoblastic Lymphoma Ann Arbor Stage II B Lymphoblastic Lymphoma Childhood B Acute Lymphoblastic Leukemia Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 Childhood B Lymphoblastic Lymphoma Down Syndrome Hypodiploid B Acute Lymphoblastic Leukemia Philadelphia Chromosome Positive B-ALL patients must be enrolled on AALL08B1 or APEC14B1 (if open for the classification of newly diagnosed ALL patients) prior to treatment and enrollment on AALL0932 Note: B-LLy patients are not eligible for AALL08B1, and can enroll directly onto AALL0932 B-ALL patients must have an initial white blood cell count < 50,000/uL Patients must have newly diagnosed National Cancer Institute (NCI) Standard Risk B-ALL or B-LLy Murphy stages I or II; patients with Down syndrome are also eligible Note: for B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted All patients and/or their parents or legal guardians must sign a written informed consent All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met With the exception of steroid pretreatment (defined below) or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL0932 Patients receiving prior steroid therapy may be eligible for AALL0932 Patients with central nervous system 3 (CNS3) leukemia CNS status must be known prior to enrollment; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment); B-LLy patients with CNS3 disease are not eligible for this protocol or the COG HR ALL protocol; it is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; this is allowed prior to registration; systemic chemotherapy must begin within 72 hours of the first dose of intrathecal therapy B-ALL patients with testicular leukemia are not eligible for AALL0932 For B-LLy patients the following additional apply T-lymphoblastic lymphoma Morphologically unclassifiable lymphoma Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-999.0, Dyspnea Acute Heart Failure Shortness of Breath Age ≥ 18 years Presentation to the ED with undifferentiated shortness of breath Dyspnea of obvious cause, e.g. chest trauma, obvious clinical exacerbation of known chronic obstructive disease Obvious pulmonary edema in a patient with a known diagnosis of HF and recently admitted to hospital for HF Clinician does not plan to treat for AHF at all, but rather to pursue other causes of dyspnea (i.e., probability of AHF ≤ 20%) Clinician plans to treat for AHF and not to pursue other causes of dyspnea (i.e., probability of AHF ≥ 80%) Acute coronary syndrome within one month Chronic renal failure (serum creatinine ≥ 250 mol/l) Anticipated life expectancy < 6 months due to non-cardiovascular causes Participation in another interventional outcome trial Inability to obtain informed consent, including inability of patient to understand English
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-999.0, Asthma Patients Men and women. Women must be surgically sterilized/postmenopausal or use double barrier method contraception months history of asthma according to ATS definition Prescribed daily dose of ICS and LABA for at least 3 months prior to Visit 2 Pre-bronchodilator FEV1 of 40 to 85 % of predicted normal A total ACQ5 score of 1.5 or more Respiratory infection significantly affecting the asthma Any significant disease and disorder that may put the patient at risk or influence study results Any clinically relevant abnormal findings A smoking history of more than 10 pack years Intake of oral, rectal or parenteral glucocorticosteroids
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 0.0-999.0, Rhinitis, Allergic, Perennial Patient Current Seasonal Allergic Rhinitis sufferer (based on physician judgement) Currently receiving prescribed INS treatment (no other treatment restrictions apply) Have consumed at least one full prescription on the specified INS treatment No comorbid Asthma or COPD diagnosis Informed Consent None specified
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-80.0, Depression, Myalgia Capable of providing informed consent American Society Anesthesiologists (ASA) rating I-III Subjects age 18-80 capable of providing consent Subjects undergoing electroconvulsive therapy using succinylcholine as the sole neuromuscular blocking agent Subjects who have scored ≥23 on the Mini-Mental State Examination Subjects who have had a recent thrombotic event, myocardial infarction or stroke or episode of Congestive Heart Failure (CHF) within less than 3 months Subjects who have had a recent cardiovascular surgery within the last 3 months Subjects with active Gastrointestinal bleeding Subjects who have asthma, itching or allergic type reaction following aspirin or other NSAID administration Subjects with a known hypersensitivity to ibuprofen Subjects with heart failure, bleeding disorders or kidney failure Subjects taking aspirin, Angiotensin converting enzyme (ACE) inhibitors, or anticoagulants within one month Subjects with any devices used to treat pain (intrathecal pumps, spinal cord stimulators etc) Subjects with a history of fibromyalgia or chronic myositis Subjects who are pregnant
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 3.0-999.0, Collection of Clinical Data That Will be Used in This Study and Will Form a Data Bank for Asthma in Saudi Arabia Identify Known and NOVEL Genetic Risk Factors Contributing to Asthma Susceptibility Study the Mechanistic Roles of the Genetic Variants Within Major Asthma Susceptibility Genes Subjects with documented clinical history of asthma for a period of at least 6 months prior to study entry (and a minimum of one clinic follow-up visit since initial diagnosis) 2. Willing to provide written informed consent and in the judgment of the investigator, individuals who are able to understand the informed consent process. 3. Subjects with documented clinical history (in preceding 12 months) of airway reversibility of at least 12% based on Forced Expiratory Volume (FEV1), measured pre and post inhalation of a β-2 agonist (2 puffs of albuterol using a measured dose inhaler with spacer) OR 4. Individuals demonstrating airway 12% reversibility during recruitment testing and asthmatic symptoms, but with no prior history of asthma and not on an asthma treatment plan, can be recruited as affected individuals if in the opinion of the investigator the individuals are truly asthmatic and have no confounding factors that could explain the reversibility and symptoms. 7. Individuals with strong history of asthma but with waning, or no current symptoms may be included in the study if their asthma was well controlled using an asthma medication. Principal investigator must verify or know the clinical history of an individual before accepting him as an asthmatic individual. 8. Individuals with positive history of asthma but no asthma medication usage and with family history of asthma should be considered for as cases in the study only if other family members are being recruited. 9. Able to perform Spirometry/FEV1 correctly (only for those above 7years) Age < 3 years 2. Smoking for 20 years, 1 pack/day or more. 3. Congestive heart failure. 4. COPD. 5. Chronic lung disease other than asthma and COPD. 6. Bronchiectasis
|
2
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-60.0, Asthma Male or female between 18 and 60 years of age 2. Non-asthmatics and mild asthmatics as defined below Non-asthmatic must have no prior diagnosis of asthma, no history of health care utilization or medication use for asthma, no current symptoms, and Forced Expiratory Volume in 1 Second (FEV1) greater than or equal to 80% predicted Asthmatics must have physician-diagnosed asthma for at least one year and evidence of mild, persistent disease during the month prior to Visit 1 (based on 2008 GINA guidelines). a) Participants who are currently taking a controller medication must: i. use the equivalent to GINA Step 1 or 2 therapy; and ii. have controlled disease, as defined by daytime symptoms less than or equal to 2 times week, such as wheezing, tightness in the chest, shortness of breath, and cough no nocturnal symptoms; b) Participants who are not currently taking a controller must have: i.<TAB>daytime symptoms > 1 time a week but < 1 time a day, such as wheezing, tightness in the chest, shortness of breath, and cough; ii. nocturnal awakenings > 2 times a month but < 1 time a week; c) All asthmatic participants must have either: i.<TAB>Pre-bronchdilator FEV1 greater than or equal to 80% predicted and a positive methacholine challenge (PC20 less than or equal to 4 mg / ml); or ii.<TAB>Pre-bronchodilator FEV1 < 80% and post-bronchodilator FEV1 greater than or equal to 80% with significant bronchodilator reversibility (at least 12% or 200ml change in FEV1) 3. Participants must be able to understand and provide written informed consent 4. Participants must be able to travel to the CRU and the EPA Use of oral steroid treatment(s) within 30 days of Visit 1 2. Acute asthma-related healthcare utilization within 30 days of Visit 1, such as ED visits, systemic corticosteroids, and nebulizer treatment for asthma exacerbation 3. Known or suspected respiratory infections within 30 days of Visit 1, such as flu, pneumonia, severe cold, tuberculosis, or bronchitis 4. Known or suspected viral infection within 30 days of Visit 1 5. History of chronic obstructive pulmonary disease other than asthma 6. History of immunological disease or current cancer 7. Uncontrolled cardiovascular disease such as angina, prior myocardial infarction, stroke, and high cholesterol 8. Cardiac malformations 9. Pulmonary hypertension 10. Bleeding disorders 11. Facial deformity, major facial surgery 12. Currently pregnant or breast feeding 13. Current smoker, significant second-hand smoke exposure (defined by urine cotinine > 100 ng/ml at Visit 1 or Visit 2) or former smokers (defined by a history of smoking > 100 cigarettes) 14. Insulin dependent diabetes 15. Used any of the following medications within 30 days of Visit 1: oral corticosteroids, systemic immunosuppressants or other immune-modifying drugs [e.g., Rituxan, Humira, Enbrel, Azathioprine (Imuran), Cyclosporine (Neoral, Sandimmune, and SangCya), cyclophosphamide, TNF antagonists], anticoagulants (clopidogrel, heparin, enoxaparin and related drugs, coumadin), and sustained use (i.e. more than one dose per day for more than two days) of non-steroidal anti-inflammatory drugs (aspirin, ibuprofen, indomethacin) within seven days of bronchoscopy 16. Allergy or history of adverse reactions to methacholine or lidocaine 17. Severe asthma as defined by a history of intubation for unstable asthma 18. Any condition that, in the investigator's opinion, places the participant at undue risk for complications (e.g. from PFTs, fiberoptic bronchoscopy, bronchalveolar lavage and/or bronchial brushings) 19. Temperature > 37.6 C; blood pressure < 90/50 mm Hg or blood pressure >170/95 mm Hg; pulse rate < 50 or > 100 beats/minute 20. Body weight < 50 kg (<110 lbs) 21. The following abnormal lab values (values obtained during clinical assessment) Platelet count < 100,000 per 10(9)/L White blood cells count < 3000 per 10(9)/L Hematocrit < 35% for both female and male Prothrombin Time (PT) / Abnormal International Normalized Ratio (INR) and partial prothromboplastin time (PTT) based on reference laboratory established reference ranges Serum creatinine > 1.4 mg/dL
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-55.0, Seasonal Allergic Rhinitis Subject is healthy History of seasonal allergic rhinitis Male aged between 18 and 55 years Body weight >/= 50 kg with BMI in range 19 kg/m2 (inclusive) Exhibits a moderate response to 4 hour exposure to grass pollen in the challenge chamber with a total nasal symptom score (TNSS) of >/= 6 Positive skin prick test (wheal >/= 4 mm) for grass pollen Positive total IgE result (RAST class >/= 2) for grass pollen Current non-smoker who has not used tobacco in the past 6 months with a pack history of </= 10 pack years Baseline FEV1 >/= 80% and FEV1/FVC >/= 70% of predicted values structural nasal abnormalities or nasal polyps, history of frequent nosebleeds, recent nasal surgery or recent (within 3 weeks) or ongoing upper respiratory tract infection history of drug allergy participation in another clinical trial or has participated in a study using an NCE within the previous 3 months, or any clinical study within 1 month taking regular (or a course of) medication whether prescribed or not, including steroids, vitamins, macrolides, anti-fungal agents and herbal remedies. Paracetamol (</= 2g / day) and occasional short acting beta agonists are permitted use of oral, injectable or dermal steroids within 5 weeks or intranasal and/or inhaled steroids within 1 week of the screening visit past or present disease, which as judged by the investigator, may affect the outcome of the study regular consumption of > 21 units alcohol per week infected with Hepatitis B, Hepatitis C, or HIV virus current or chronic history of liver disease, or known hepatic or biliary abnormalities positive test for drugs of abuse or alcohol at screening
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-65.0, Asthma Males and females, 18 to 65 years of age. 2. FEV1 60-85% of predicted on the screening day. - Women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women. 2. Cardiovascular disease and/or use of cardiovascular medications 3. Subjects with known beta-adrenergic agonist or glucocorticosteroid intolerance 4. Acute respiratory infection within four weeks prior to the study 5. Use, within two weeks prior to the study, of any anti-asthma medication not mentioned above -
|
2
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 12.0-70.0, Asthma Provision of informed consent by the subject and his/her legal guardian if the subject is under 18 years old Male or females aged more than 12 and under 70 Had a definite diagnosis of asthma with symptoms of cough/expectoration/chest tightness/wheeze/breathlessness within the last one month Inhaled corticosteroid (ICS) naïve or no regular use of ICS within the last one month (It is suggested that ICS average daily dose with no more than 100mg budesonide or equal within the last month as "No-regular-use") FEV1 between 60% and 85% of predicted normal values Reversibility test of airway obstruction is positive, i.e. degree of reversibility in FEV1 as over 12%(included) and 200ml(included). Or average diurnal PEFR variability is not less than 20% in two weeks Are able to use Peak Flow Meter and record it on patient diary card Asthma exacerbation leading to hospitalization for more than 2 days within the last 6 months or emergency room visit due to asthma exacerbation in the last 3 months prior to screening Infection of respiratory system in the last 4 weeks prior to screening visit Use of oral, injectable, rectal or transdermal glucocorticoid in the last 4 weeks prior to screening visit Use of Leukotriene receptor antagonist (LTRAs), oral b2 agonist, methylxanthines or use of inhaled long acting b2 agonist, inhaled anticholinergic receptor in the last 1 week, or inhaled Tiotropium Bromide within 45 days prior to screening visit Patients with chronic obstructive pulmonary disease (COPD)or COPD with asthma Patients with severe persistent asthma (Based on definition in GINA 2006) Patients with specific immunity treatment (including monoclonal antibody treatment) due to asthma within the 6 months prior to screening visit Patients with eye disorders including cataract, glaucoma and herpes virus infection Smoking history of 10 pack-year (1 pack-year refers to 20 cigarette per day for 1 year) History of drug or alcohol abuse
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 16.0-49.0, Persistent Cough Whooping Cough Male or Female, aged 16 years to 49 years inclusive Presenting with a persistent cough of 2-8 weeks' duration without an established diagnosis (e.g. asthma, gastro-oesophageal reflux) Able to complete cough diary and study questionnaires There is a contraindication to montelukast Chronic severe disease which may cause persistent cough (eg cystic fibrosis, bronchiectasis, cardiac failure) Immunodeficiency/immunocompromised state Pregnancy Breastfeeding Current smoker (i.e. stopped smoking less than 6 months ago) Regular medication associated with persistent cough (ACE inhibitors) The individual is in another clinical research study
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 0.0-999.0, Asthma all with asthma diagnosis none
|
2
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-65.0, Asthma A clinical diagnosis of persistent mild to moderate asthma requiring at least 3 months of daily treatment with inhaled corticosteroids (ICS). 2. A FEV1 value at Screening that is 60-90% of predicted FEV1. 3. Age 18 to 65, males or females Diagnosis or presence of other pulmonary diseases including chronic obstructive pulmonary disease (COPD) and emphysema. 2. Previous life-threatening asthma, such as asthma requiring intubation or ICU admission for asthma. 3. Prolonged hospitalization for asthma within the past year (emergency room treatments using nebulized beta-agonists is permitted). 4. Not able and willing to stop the use of long-acting beta-agonists (LABAs), cromolyn sodium, methylxanthines, anticholinergic agents, leukotriene inhibitors, or any other non-ICS or non-SABA prescription or over-the-counter anti-asthma medication, including antihistamines, during Screening and during the Study. 5. Use of moderate to strong cytochrome P450 3A4 (CYP3A4) inhibitors. 6. Use of oral steroids within the last 1 month, or use of >/= 3 steroid bursts in the last 12 months. 7. History of upper respiratory tract infection (URI) requiring treatment during the last month prior to Screening. 8. Tobacco use within 3 months prior to Screening, or > 5 pack-year lifetime tobacco use. 9. Use of smoking cessation therapy within 3 months prior to Screening. 10. Uncontrolled Gastroesophageal reflux disease (GERD). Subjects on a stable dose of non-prescription or prescription medications who have been symptom free for 4 wks prior to screening are eligible. 11. History within past 6 months of alcohol abuse or illicit drug abuse. 12. Myocardial infarction within 12 months prior to Screening. 13. Known hypothyroidism, vitamin B12, or folic acid deficiency. 14. Known systemic infection (HBV, HCV, HIV, TB). 15. FSH level of < 35 IU/L and a LH level < 25 IU/L. 16. Urine cotinine level > 50 ng/ml. 17. Body Mass Index (BMI) <15 and >35. 18. Participation in another clinical trial in the past 3 months
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 12.0-999.0, Rhinitis Seasonal Patients with seasonal allergic rhinitis (SAR): Patients with a history of SAR symptoms during the season when cedar pollen levels are increased for at least 2-years At the start of the placebo lead-in period Patients who are negative for IgE Antibody test Expected nasal congestion score is less than 2 The last 3 days of the lead-in period Nasal congestion scores are 2 or more and not all 4 Patients with all nasal symptoms (sneezing, rhinorrhea, and nasal congestion). A total score for nasal symptoms (sneezing, rhinorrhea, and nasal congestion) and eye symptom is less than 6 Patients with 2 or more nasal symptoms (sneezing and rhinorrhea) and eye symptoms score is 4 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-45.0, Healthy Asthma Male healthy subjects and male asthma patients aged 18 to 45 years (inclusive) Have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive and rounding allowed) and weight between 50 and 100 kg (inclusive) Be able to inhale from the SPIRA nebuliser and I-neb® according to the provided instructions Asthma patients should fulfil the following Pre-bronchodilator forced expiratory volume at 1 second (FEV1) ≥70% of predicted normal value Asthma diagnosis according to GINA guidelines with a history of episodic wheeze and shortness of breath History of any clinically significant disease or disorder Any clinically relevant abnormal findings Current smokers Asthma patients: Worsening of asthma or respiratory infection within 6 weeks before screening Asthma patients: Use of inhaled, nasal, oral, rectal or parenteral corticosteroids within 30 days before first administration of investigational product and during the study
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 12.0-999.0, Asthma Subjects with asthma as determined by ICD-9 codes and asthma drug use at least 12 years of age discharged from an initial Emergency Department visit within 12 months Subjects with COPD or treatment for COPD
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-999.0, Driving Distress Secondary to Trauma During Deployment Driving-related distress secondary to conditions of OEF/OIF deployment 2. Possesses valid driver's license 3. Owns vehicle registered in his/her name 4. Vehicle currently insured in his/her name 5. Drives regularly (e.g. to regularly scheduled activities such as work or school) 6. Drives to all driving rehabilitation appointments Any moving violations since discharge from the military 2. Any central nervous system injury or disease 3. Psychotic disorder and/or any psychotic signs or symptoms 4. Current alcohol or substance abuse/dependence (required answer: "yes" or "no", only) 5. Severe Post-traumatic Stress Disorder (as indicated by a PTSD Checklist (PCL) score greater than 60) 6. Severe Depression(as indicated by a Beck Depression Inventory-II score greater than 28) 7. Amputation or restricted mobility of any limb
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-999.0, Obesity Morbid Obesity Venous Thromboembolism Atrial Fibrillation Angina Chest Pain Patients with body mass index greater than or equal to 30 Patients admitted to Nazareth Hospital inpatient units Weight-based intravenous heparin, with a diagnosis of atrial fibrillation, suspected or confirmed deep vein thrombosis or pulmonary embolism, unstable angina or Non ST elevation myocardial infarction with hemodynamic stability, or peripheral vascular disease, ordered at the time of admission/transfer or during the patient stay in the Intensive Care unit or Progressive Care unit Prior permission from the patient's attending physician Permission from the physician who ordered the intravenous weight-based heparin (if different from the attending) Signed consent form by the patient Patients with stroke, TIA, or ST elevation myocardial infarction Patients who have hemodynamic or cardiopulmonary instability at the time of intravenous heparin order Patients with thrombophilia Patients who are pregnant or may be pregnant Those patients who have been on any oral anticoagulants (Warfarin, rivaroxaban, dabigatran or apixaban), treatment dose of other anticoagulants or intravenous thrombolytics in previous 7 days Patients who have a PTT greater than 37 seconds History of heparin-induced thrombocytopenia or known allergy to heparin Deviation from the Weight-based heparin protocol ordered by a physician at the time intravenous heparin was written (i.e. no bolus dose ordered, different target therapeutic aPTT range, different bolus dose per kg, etc.) Informed consent either refused or not obtained Objection from a physician caring for the patient
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-999.0, Orthostatic Hypotension The presence of orthostatic hypotension (fall in systolic BP greater than or equal to 30 mm Hg) is required for this study; 2. Autonomic testing and clinical evaluation demonstrates OH to be of neurogenic etiology
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 30.0-80.0, COPD Asthma Male or female outpatients aged 40-80 years inclusive An established clinical history of COPD as defined by the GOLD guidelines COPD patients with a baseline (pre-bronchodilator) FEV1 40-80% of predicted normal value; post-bronchodilator FEV1/FVC ratio ≤ 70% predicted COPD patients with a smoking history (current or ex-smoker) of ≥10 pack years or those who have exposure to occupational dust and chemicals An established clinical history of asthma defined by the GINA recommendations Subjects with out hypoxemia (all subjects must have an O2 saturation ≥88% on room air). Control (healthy) subjects with baseline FEV1 >80% of predicted normal value A female is eligible to participate this study if she is of non-childbearing potential, or childbearing potential has a negative pregnancy test Patients who did not use inhaled and oral corticosteroids 6 weeks and/or long acting bronchodilators 4 weeks before study There is a current respiratory disorder other than COPD and asthma (e.g. lung cancer, sarcoidosis, active tuberculosis etc.) Subjects who have had a COPD and asthma exacerbation or respiratory infection in the 4 weeks before Visit 1 Subjects with a chest X-ray indicating diagnosis other than COPD or asthma that might interfere with the study Subjects who are unable to stop treatment with inhaled, and oral corticosteroids 6 weeks and/or long acting bronchodilators 4 weeks before study Subjects receiving treatment with cromolyn sodium or nedocromil, oral beta2 - agonists, long acting anticholinergic, leucotriene modifiers Subjects who have had lung surgery Subjects with bleeding diathesis Subjects receiving treatment with long-term oxygen therapy Subjects with serious, uncontrolled diseases those are uncontrolled on permitted therapy
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 12.0-65.0, Asthma Male and female patients aged at least 12 to 65 years 2. All patients must have a history of asthma diagnosed by a physician for at least three months at the time of enrolment into the trial according to the 2009 Global Initiative for Asthma (GINA) Guidelines. The initial diagnosis of asthma must have been made before the age of 40 years 4 All patients must be on a maintenance treatment with either low-dose inhaled corticosteroid (ICS) plus long-acting-beta -agonist (LABA) or medium-dose ICS without LABA, stable for at least six weeks prior to Visit 1 5 All patients must have a pre-bronchodilator FEV1 of not less than 60 to 90% of predicted normal and an asthma control questionnaire (ACQ-6) mean score of less than 1.5 at the pre-screening Visit 1 6 All patients must have an improvement in forced expiratory volume in one second (FEV1) not less than 12 % above baseline and an absolute change of at least 200 mL within 15-30 min after administration of 400 mcg salbutamol/albuterol hydrofluoroalkane metered dose inhaler (HFA MDI) 7 Patients must be never-smokers or ex-smokers with a smoking history of less than 10 pack-years and smoking cessation at least one year prior to screening 9 Patients must be able to use Respimat® inhaler and metered dose inhaler (MDI) correctly 10 Patients must be able to perform all trial-related procedures including technically acceptable pulmonary function tests and electronic peak expiratory flow (PEF) measurements, and must be able to maintain records during the study period as required in the protocol Patients with significant pulmonary disease other than asthma or other significant medical conditions (as determined by medical history, examination and clinical investigations at screening) 2. Patients with a clinically relevant, abnormal screening haematology and/or blood chemistry finding 3. Patients with a history of upper or lower respiratory tract infection (URTI/LRTI) in the past four weeks prior to the pre-screening Visit 1, and during pre-screening and run-in periods 4. Patients with any exacerbation of their underlying asthma during the eight weeks prior to the pre-screening Visit 1 5. Patients with active allergic rhinitis requiring treatment with systemic corticosteroids 6. Any of the following are met during the pre-screening / run-in period (Visits 1 :in clinic pre-bronchodilator forced expiratory volume in one second (FEV1 %) predicted less than 40%; more than 12 puffs rescue salbutamol/albuterol HFA MDI per day for > 2 consecutive days;exacerbation of asthma 7. Patients with a history of pneumonectomy or who are planning to undergo thoracotomy for any reason 8. Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the six weeks prior to the first screening visit 1 9. Patients with two or more hospitalizations for asthma within the previous 12 months 10. Patients with a recent history of myocardial infarction during the last twelve months or known coronary heart disease that requires treatment 11. Patients with a history of hospitalisation due to heart failure in the past twelve months 12. Patients with myocarditis or any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year 13. Patients with significant alcohol or drug abuse in the opinion of the investigator within the past two years 14. Patients with rheumatoid arthritis or other systemic diseases that require immune system modulating treatment 15. Patients suffering from narrow angle glaucoma with a history of glaucoma, increased intraocular pressure, and/or cataracts 16. Pregnant or nursing women 17. Women of childbearing potential not using a highly effective method of birth control 18. Patients who have been treated with anti-Immunoglobin-E-antibodies (e.g. omalizumab, Xolair®) or other immune system modulating antibodies such as tumor necrosis factor-alpha blockers within six months prior to Visit 1 19. Patients who have been treated with the following drugs during the past four weeks prior to Visit 1 or are foreseen to need this during the study:Non-selective beta-blockers (topical cardio-selective beta-blocker eye medications for non-narrow angle glaucoma are allowed; Oral or other systemic corticosteroids; Oral beta-agonists; Changes in allergen desensitisation therapy in last 6 months; Immune system modulating agents such as methotrexate or cyclosporine; Inhibitors of cytochrome P450 3A4 such as antifungals (e.g. ketoconazole, itraconazole), antibiotics (e.g. erythromycin) or antiretroviral drugs; Patients who have been treated with leukotriene modifiers, chromones or theophylline within two weeks prior to Visit 1; Patients who have been treated with tiotropium within 3 weeks prior to Visit 1
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 12.0-65.0, Asthma Must be willing and able to give informed consent 2. Male and female patients aged at least 12 to 65 years 3. All patients must have a history of asthma diagnosed by a physician for at least three months at the time of enrolment into the trial according to the 2009 Global Initiative for Asthma (GINA) Guidelines. The initial diagnosis of asthma must have been made before the age of 40 years 4. All patients must be on a maintenance treatment with either medium-dose inhaled corticosteroid (ICS) plus long acting beta agonist (LABA) or high-dose inhaled corticosteroid (ICS) without long acting beta agonist (LABA), stable for at least six weeks prior to Visit 1 5. All patients must have a pre-bronchodilator forced expiratory volume in one second (FEV1) of not less than 60 to 90% of predicted normal and an asthma control questionnaire (ACQ-6) mean score of less than 1.5 at the pre-screening Visit 1 6. All patients must have an improvement in FEV1 not less than 12 % above baseline and an absolute change of at least 200 mL within 15-30 min after administration of 400 mcg salbutamol/albuterol hydrofluoroalkane metered dose inhaler (HFA MDI) 7. Patients must be never-smokers or ex-smokers with a smoking history of less than 10 pack-years and smoking cessation at least one year prior to screening 8. Patients must be able to use Respimat® inhaler and metered dose inhaler (MDI) correctly 9. Patients must be able to perform all trial-related procedures including technically acceptable pulmonary function tests and electronic peak expiratory flow (PEF) measurements, and must be able to maintain records during the study period as required in the protocol 10. To enter treatment period following additional have to be met (at randomisation visit) During the run-in period (at the same clinic visit) all patients must be both symptomatic (ACQ-6 mean score equal to or greater than 1.5) and have shown a decrease in morning pre-bronchodilator FEV1 not less than 10% and less than or equal to 25% from pre-screening baseline FEV1 at Visit 2 Patients with significant pulmonary disease other than asthma or other significant medical conditions (as determined by medical history, examination and clinical investigations at screening) 2. Patients with a clinically relevant, abnormal screening haematology and/or blood chemistry finding 3. Patients with a history of upper or lower respiratory tract infection in the past four weeks prior to the pre-screening Visit 1, and during pre-screening and run-in periods 4. Patients with any exacerbation of their underlying asthma during the eight weeks prior to the pre-screening Visit 1 5. Patients with active allergic rhinitis requiring treatment with systemic corticosteroids 6. Any of the following are met during the pre-screening / run-in period (Visits 1 in clinic pre-bronchodilator forced expiratory volume in one second (FEV1 %) predicted less than 40% more than 12 puffs rescue salbutamol/albuterol hydrofluoroalkane metered dose inhaler (HFA MDI) per day for > 2 consecutive days exacerbation of asthma. 7. Patients with a history of pneumonectomy or who are planning to undergo thoracotomy for any reason 8. Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the six weeks prior to the first screening visit 1 9. Patients with two or more hospitalizations for asthma within the previous twelve months 10. Patients with a recent history of myocardial infarction during the last twelve months or known coronary heart disease that requires treatment 11. Patients with a history of hospitalisation due to heart failure in the past twelve months 12. Patients with myocarditis or any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year 13. Patients with significant alcohol or drug abuse in the opinion of the investigator within the past two years 14. Patients with rheumatoid arthritis or other systemic diseases that require immune system modulating treatment 15. Patients suffering from narrow angle glaucoma with a history of glaucoma, increased intraocular pressure, and/or cataracts 16. Pregnant or nursing women 17. Women of childbearing potential not using a highly effective method of birth control. 18. Patients who have been treated with anti-Immunoglobin-E-antibodies (e.g. omalizumab, Xolair®) or other immune system modulating antibodies such as tumor necrosis factor-alpha blockers within six months prior to Visit 1 19. Patients who have been treated with the following drugs during the past four weeks prior to Visit 1 or are foreseen to need this during the study Non-selective beta-blockers (topical cardio-selective beta-blocker eye medications for non-narrow angle glaucoma are allowed) Oral or other systemic corticosteroids Oral beta-agonists Changes in allergen desensitisation therapy in last 6 months Immune system modulating agents such as methotrexate or cyclosporine Inhibitors of cytochrome P450 3A4 such as antifungals (e.g. ketoconazole, itraconazole), antibiotics (e.g. erythromycin) or antiretroviral drugs
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 2.0-80.0, Chronic Cough Age 2-80 years Patients with significant chronic cough Patients in hemodynamic stability. Patient is not in respiratory distress Subject or subject's parents/guardians is able to comprehend and give informed consent for participation in the study Contraindication to the use of the PulmoTrack™ or performing ARM (Acoustic Respiratory Monitoring) Hemodynamic instability and/or SOB Concurrent additional major illness Concurrent participation in any other study Physician objection
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-65.0, Bronchial Asthma subjects aged between 18 and 65，without acute upper respiratory tract infection for the past 2 weeks had a normal chest radiographic result had a baseline spirometry with the forced expiratory volume in one second (FEV1) of not less than 60% predicted had withheld leukotriene receptor antagonists (LTRA) for over 5 days oral glucocorticosteroid or anti-histamine for 3 days oral xanthenes or long-acting bronchodilators for 2 days inhaled corticosteroid or long-acting bronchodilator for a day as well as short-acting bronchodilator for 4 hours prior to the measurement subjects had a fall of no less than 15% in FEV1 after repetitive forced respiration or a fall of no less than 20% in FEV1 after the inhalation of ethanol diluent control had a past confirmed history of respiratory disease other than bronchial asthma (COPD, bronchiectasis, pulmonary thromboembolism, etc.) or other severe systemic disease（myocardial infarction, malignant tumor, etc.） had a poor cooperation to the test or limited understandings, were immunocompromised, or had participated other clinical trials for the past 3 months
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 12.0-65.0, Asthma One or more medical claims with a diagnosis (primary or secondary) of asthma (ICD-9-CM 493.XX) during study period One or more outpatient pharmacy claims during the study for one or more of the following "study medications" Fluticasone propionate/salmeterol xinafoate 250 mcg/50 mcg or 100mcg/50mcg combinations Fluticasone propionate 110 mcg or 220 mcg One or more asthma exacerbations (asthma-related hospitalization or emergency department visit, oral corticosteriod prescription drug claim, or a combination of any of the above events) during the 12 months prior to the index date ("pre-index period") or Five or more prescriptions for a short-acting beta agonist during the pre-index period Patients with more than one of the study medications during the 3-month period beginning with the index date One or more prescriptions within three months of index date (pre or post) for an ICS or LABA other than the study medications One or more prescriptions within three months of post index date for Any asthma maintenance medication Any medical claims during study period with a diagnosis of: Chronic obstructive pulmonary disease (COPD) (ICD-9-CM 491, 492, or 496); or Respiratory tract cancer (ICD-9-CM 160-164, or 231)
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 12.0-50.0, Asthma Outpatient male or female 12 to 50 years of age Females of child-bearing potential must be willing to use birth control or commit to abstinence during the study Diagnosis of persistent asthma for at least 6 months Best pre-bronchodilator FEV1 of at least 70% Current use of a low to moderate-dose inhaled corticosteroid Ability to withhold albuterol 6 hours prior to visits Physically able to perform exercise testing on a treadmill when albuterol has been withheld Intermittent asthma, seasonal asthma, or exercise-induced asthma only Symptomatic allergic rhinitis and/or thrush Abnormal, clinically significant electrocardigraph Respiratory infection within 4 weeks of first visit leading to asthma medication change or could affect subjects's asthma status or participation Asthma exacerbation within 12 weeks of first visit Respiratory diseases or other concurrent disease that would put subject at risk or confound results interpretation Investigational medicines within 30 days of first visit or less than five half-lives of medication in prior study Allergy to study drugs or study drug excipients Concomitant medications that could interact with study medications or affect the course of asthma Tobacco use within last year and/or a 10 pack-years history
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-65.0, Asthma The patient provides written informed consent to participate in the study 2. Male or female patient aged 18 to 65 years 3. Documented diagnosis of asthma 4. Forced Expiratory Volume in One Second (FEV1) between 50% and 80% of the predicted value 5. Patient judged by the investigator to be in otherwise good stable health based on medical history, physical examination, and routine laboratory data 6. Female participants must have a negative pregnancy test at screening visit 7. Males must agree to use barrier contraception while on study medication and for 90 days after taking the last dose of study medication Pregnant or lactating women 2. Female subjects on hormone replacement therapy or hormonal contraceptives 3. Suffering from relevant lung diseases (other than asthma) causing impairment in lung function 4. Past smoker with a history of ≥10 pack per year or current smoker 5. Recent change in the patient's usual asthma treatment 6. Patients with risk factors for asthma exacerbation during the study, including (any of the following) Current requirement for > 8 puffs per day of reliever medication Hospitalization for asthma Treatment with systemic corticosteroid therapy within 3 months 7. Evidence of current or recent neoplastic disease 8. Clinically significant cardiovascular, haematological, endocrine, neurological, gastrointestinal, psychiatric, metabolic, immunologic, infectious, hepatic, renal, gynaecological disease or other condition that the investigator considers detrimental to the patient's participation in the study or that may prevent the successful completion of the study 9. Positive serology for an infectious disease (including hepatitis B or C) at screening and known case of human immunodeficiency virus [HIV] 10. Patients who have been hospitalized for any psychiatric illness in the past year, or are diagnosed with major depression 11. Clinically significant ECG Abnormality at baseline 12. Patients with documented or suspected or current history of alcohol and drug abuse 13. Patients who have undergone lung surgery in the previous year 14. Participation in an investigational drug trial during 30 days preceding screening
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-65.0, Asthma Physician diagnosis of asthma, as per the Global Initiative for Asthma (GINA) (2009) guidelines, and currently prescribed Inhaled Corticosteroids (ICS) therapy Patients with a pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) value of 40% to 80% of individual predicted value Patients should be allergic or atopic, as diagnosed historically or prior to entry into the study Patients who are demonstrated to have reversible airway obstruction or airways hyper-reactivity or have shown either of such responses in previous test(s) within the last year An Asthma Control Questionnaire (ACQ) score ≥ 1.5 at randomization Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL) Patients with serious co-morbidities including uncontrolled diabetes (HbA1c≥8%), heart failure, cancer, neurodegenerative diseases, rheumatoid arthritis and other autoimmune diseases, other lung diseases including chronic bronchitis, chronic obstructive pulmonary diseases or emphysema or other conditions characterized by eosinophilia and pulmonary symptoms (i.e. Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, eosinophilic pneumonia, etc.) Acute illness other than asthma at the start of the study History of life-threatening asthma, including a history of significant hypercarbia (pCO2>45mmHg), prior intubation, respiratory arrest, or seizures as a result of asthma Patients who have had a respiratory tract infection within 4 weeks of the screening visit. Patients who develop a respiratory tract infection between screening and the randomization visit must be screen failed, and may be permitted to re-enroll at a later date Current smokers or ex-smokers who stopped smoking within 6 months prior to screening or have a smoking history of ≥ 10 pack years
|
2
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-999.0, Allergic Rhinitis Allergic Conjunctivitis provide written informed consent and signed HIPAA form be able and willing to follow all instructions and attend the study visits if female and of childbearing potential, be not pregnant, nursing or planning a pregnancy, be willing to submit a pregnancy test at Visit 1 and at exit visit, and to use adequate method of birth control have a positive history of seasonal allergic rhinitis to ragweed have a positive skin test reaction to ragweed of within the past 24 months manifest sufficient allergic rhinitis symptoms during ragweed exposure in the ABC known intolerance or allergy to antihistamines or corticosteroids have a compromised lung function at Visit 1 develop a compromised lung function at Visits 2-6 have any presence of active sinus or nasal infection at any visit have experienced an acute upper or lower respiratory tract infection or acute sinusitis within 30 days of visit 1 have significant nasal anatomical deformities or any condition that does not allow subject to breathe through the nose (includes, but is not limited to: septal deviation, septal perforations, nasal polyps, rhinitis medicamentosa) have had any nasal surgical intervention in the past have a known history of glaucoma have planned surgery (nasal, ocular or systemic) during the trial period or within 30 days thereafter inability or refusal to discontinue contact lens wear during all visits
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 12.0-56.0, Asthma KPSC members at time of uncontrolled event: 1. 12-56 years of age 2. Continuously enrolled and with pharmacy benefit for the past year 3. Dispensed inhaled corticosteroid (ICS) in the past 6 months. 4. Uncontrolled asthma: defined within the past year Impairment cohort: 7th short-acting beta-agonist (SABA) canister dispensed and/or Risk (exacerbation) cohort: 2nd oral corticosteroid (OCS)dispensing with provider asthma exacerbation encounter within 2 days and at least 1 month after the first OCS dispensing Patients with chronic obstructive lung disease emphysema cystic fibrosis chronic bronchitis bronchiectasis Churg Strauss Wegener's sarcoidosis pulmonary hypertension or other clinically relevant non-asthma pulmonary disorder such as autoimmunity immune deficiency
|
2
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-999.0, Nasal Allergies Allergies Stage A Willing and able to give written informed consent In good health in the opinion of an appropriately qualified physician Females of childbearing potential (who are not at least 1 year post-menopausal or surgically sterilized) must have a negative urine pregnancy test at Visit 1, and must not be nursing or plan to become pregnant during the course of the study Other protocol-defined may apply. Stage B History of non-recalcitrant seasonal allergic rhinitis during the fall allergy season Allergy to short ragweed allergen, defined by positive skin prick test for short ragweed allergen within the 12 months prior to Visit 1 Be in good health in the opinion of an appropriately qualified physician Females of childbearing potential (who are not at least 1 year post-menopausal or surgically sterilized) must have negative urine pregnancy test at Visit 1, and must not be nursing or plan to become pregnant during the course of the study Other protocol-defined may apply. Stage A Hypersensitivity to the study drug or any component of the test articles, including benzalkonium chloride Using any prescription or non-prescription systemic or topical medications, vitamins or dietary supplements within 14 days prior to the check-in day (except for acetaminophen at doses of < 2 grams/day or topical, hormonal-oral, implantable or injectable contraceptives) Current or recent history of severe, unstable, or uncontrolled conditions based upon a review of medical history and/or physical examination Any nasal disorder that could preclude safe administration of study medication and/or interfere with the evaluation of the study medication History of HIV, hepatitis B or active hepatitis A as determined by medical history and/or by serology at the Screening Visit Any screening clinical laboratory result (hematology, serum chemistry or urinalysis) outside the normal range that is clinically relevant in the opinion of an appropriately qualified physician and/or Alcon physician Participation in any investigational study within 30 days of entry into this study or concomitantly with this study Other protocol-defined may apply. Stage B Any screening clinical laboratory result (hematology, serum chemistry or urinalysis) outside the normal range that is clinically relevant in the opinion of an appropriately qualified physician and/or Alcon physician
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-55.0, Exposure to Pollution Inhalation of Ozone Healthy Individuals Specific 1. Physical exams will be performed by study physicians during the screening visit (IRB approved EPA protocol 95-EPA-66). 2. Normal lung function (pre or post albuterol), defined by Knudson 1976/1984 as FVC of > 75 % of that predicted for gender, ethnicity, age and height FEV1 of > 75 % of that predicted for gender, ethnicity, age and height FEV1/FVC ratio of > 75 % of predicted values. 3. Oxygen saturation of > 96 %. 4. Ability to tolerate intervals of moderate exercise Mild to Moderate Asthmatics 1. Physical exams will be performed by study physicians during the screening visit (IRB approved EPA protocol 95-EPA-66) where diagnosis will be judged by EPA physicians. 2. Mild/Moderate asthmatics as defined by NHLBI guidelines. 3. Positive history of asthma (wheezing, chest tightness, and reversible airway obstruction); 4. Baseline FEV1/FVC ≥ 60%; 5. Oxygen saturation of ≥ 94% 6. Ability to tolerate moderate exercise Healthy Individuals 1. A history of chronic illnesses such as diabetes, rheumatological diseases, immunodeficiency state, known clinically significant cardiac disease (including myocardial infarction, congestive heart failure and angina), chronic respiratory diseases such as chronic obstructive pulmonary disease, and lung cancer. 2. If the subject is pregnant, attempting to become pregnant or breastfeeding. 3. Allergy to any medications which may be used or prescribed in the course of this study. 4. Subjects currently taking mega doses of vitamins and supplements, homeopathic/naturopathic medicines or medications which may impact the results of the PM and/or ozone challenge or interfere with any other medications potentially used in the study (to systemic steroids and beta blockers). Subjects must refrain from all over the counter anti-inflammatory agents including those for allergies, and naproxen, and anti-oxidants for a period of one week prior to exposure. Medications not specifically mentioned here may be reviewed by the investigators prior to a subject's in the study. 5. Smoking history within 2 years of the study. 6. Use of inhaled steroids, cromolyn, or leukotriene inhibitors (Montelukast, Zafirkulast, etc) initiated within the past month (except for use of cromolyn exclusively prior to exercise). Patients must be on a stable regimen of therapy. 7. Untreated hypertension (> 150 systolic, > 90 diastolic) 8. Dementia. 9. Unspecified illnesses, which in the judgment of the investigator might increase the risk associated with PM inhalation challenge or exercise, will be a basis for exclusion. 10. History of skin allergy to tape or electrodes. 11. Subjects who do not understand or speak English 12. Subjects who are unable to perform moderate exercise for bronchoscopy: 1. Any food or fluids after midnight prior to bronchoscopy 2. FEV1/FVC ratio less than 60% predicted on AM of bronchoscopy. 3. Regular use of aspirin or other nonsteroidal anti-inflammatory drugs (which inhibit platelet function). Mild to Moderate Asthmatics Use of oral steroid therapy within the past month 2. Physician directed emergency treatment for asthma exacerbation within the preceding 6 months. 3. Abnormal EKG that precludes evaluating heart rate variability. 4. Aside from mild/moderate asthma, a history of chronic illnesses such as diabetes, rheumatological diseases, immunodeficiency state, known clinically significant cardiac disease (including myocardial infarction, congestive heart failure and angina), chronic respiratory diseases such as chronic obstructive pulmonary disease or severe asthma, and cancer (possible exception for history of nonmelanoma skin cancer). 5. If the subject is pregnant, attempting to become pregnant or breastfeeding. 6. Allergy to any medications which may be used or prescribed in the course of this study 7. Subjects currently taking mega doses of vitamins and supplements, homeopathic/naturopathic medicines or medications which may impact the results of the PM challenge or interfere with any other medications potentially used in the study (to systemic steroids and beta blockers). Subjects must refrain from all over the counter anti-inflammatory agents including those for allergies, and naproxen, and anti-oxidants for a period of one week prior to exposure. Medications not specifically mentioned here may be reviewed by the investigators prior to a subject's in the study. 8. Dosing level of an inhaled steroid must be consistent with mild asthma as outlined by the NHLBI NAEPP guidelines. Regular use of oral corticosteroids, or use of inhaled steroid at doses typically used for severe asthma, will result in of that individual from the protocol. 9. Severe asthmatics as defined by: nighttime symptoms of cough or wheeze greater than 1 time per week at baseline, daily exacerbation of asthma or requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness, but not to prophylactic use of albuterol prior to exercise), more than mild interference with normal activity, any episode of physician directed emergency treatment for asthma requiring oral corticosteroid therapy within the past twelve months. 10. Smoking history within 2 years of study. 11. Use of inhaled steroids, cromolyn, or leukotriene inhibitors (Montelukast, Zafirkulast, etc) initiated within the past month (except for use of cromolyn exclusively prior to exercise). Patients must be on a stable regimen of therapy. 12. History of skin allergy to tape or electrodes. 13. History of respiratory diseases other than allergic rhinitis and asthma 14. Untreated hypertension (> 150 systolic, > 90 diastolic) 15. Dementia. 16. Unspecified illnesses, which in the judgment of the investigator might increase the risk associated with PM inhalation challenge or exercise, will be a basis for exclusion. 17. Subjects who do not understand or speak English 18. Subjects who are unable to perform moderate exercise for bronchoscopy: 1. Any food or fluids after midnight prior to bronchoscopy 2. FEV1/FVC ratio less than 60% predicted on AM of bronchoscopy. 3. Regular use of aspirin or other nonsteroidal anti-inflammatory drugs (which inhibit platelet function)
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-80.0, Asthma ALL Available for the duration of the study and able to attend the clinic for all study visits Gender: male or female A female subject is eligible to participate if she is of Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the protocol allowed contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method Child-bearing potential and agrees to use one of the protocol allowed contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until they have attended the site for the follow-up visit Capable of giving informed consent, which includes compliance with the study requirements and restrictions listed in the consent form Body mass index between 18 and 35 kg/m2 inclusive at Screening Able to use the inhaler devices adequately after training AST and ALT < 2xULN (upper limit of normal); alkaline phosphatase and bilirubin less than or equal to 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) QT interval corrected for heart rate (QTc)* <450 millisecond (msec)** QTc <480 msec for patients with bundle branch block ALL Any clinically relevant medical condition or abnormality identified during the screening medical assessment and procedures, physical examination, or laboratory assessments (including clinical chemistry and haematology), which in the opinion of the GSK Medical Monitor is likely to affect the safety of the subject and/or interfere with the study procedures and outcomes Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody or positive HIV test result within 3 months of screening Patients on treatment with fluticasone propionate either as monotherapy or in combination at a total daily dose higher than 500mcg or budesonide monotherapy or in combination at a total daily dose higher than 800mcg are excluded from the study Use of oral/injectable/depot corticosteroid for any indication within 3 months prior to the Screening visit Use of intra-nasal steroids (INS). To be eligible for the study, patients on INS therapy will be required to switch to non-INS therapy at randomization Patients with abnormal levels of serum cortisol at Screening Abuse of alcohol consumption within 12 months of the Screening visit defined by the following Australian guidelines: Males: An average weekly intake greater than 21 units or an average daily intake greater than 3 units. Females: An average weekly intake greater than 14 units or an average daily intake greater than 2 units. One unit is equivalent to 270 mL of full strength beer, 470 mL of light beer, 30 mL of spirits and 100 mL of wine A known or suspected history of drug abuse within 12 months of the Screening visit
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 12.0-100.0, Asthma Informed Consent: All subjects must be able and willing to give written informed consent to take part in the study. 2. Type of Subject: Outpatients, of Asian ancestry, 12 years of age or older at Visit 1 (or ≥18 years of age or older if local regulations or the regulatory status of study medication permit enrolment of adults only), with a diagnosis of asthma as defined by the Global Initiative for Asthma [GINA, 2009] at least 12 weeks prior to Visit 1. 3. Gender: Male or Eligible Female, defined as non-childbearing potential or childbearing potential using a protocol defined acceptable method of birth control consistently and correctly. Female subjects should not be enrolled if they are pregnant, lactating or plan to become pregnant during the time of study participation. A serum pregnancy test is required for females of childbearing potential at the initial Screening Visit (Visit 1) and Visit 5 or Early Withdrawal 4. Severity of Disease: A best FEV1 of 40%-90% of the predicted normal value at the Visit 1, Screening visit. Predicted values will be based upon III using the adjustment for Asians [Hankinson, 2010]. 5. Reversibility of Disease: Demonstrated ≥12% and ≥200mL reversibility of FEV1 within 10-40minutes following 2-4 inhalations of albuterol/salbutamol inhalation aerosol (or one nebulised treatment with albuterol/salbutamol solution) at the Screening Visit. 6. Current Anti-Asthma Therapy: All subjects must be using an ICS, with or without LABA, for at least 12 weeks prior to Visit 1, in accordance with the protocol defined acceptable dose ranges. 7. Short-Acting Beta2-Agonists: All subjects must be able to replace their current short-acting beta2-agonists with albuterol/salbutamol inhaler at Visit 1 for use as needed for the duration of the study. Subjects must be able to withhold albuterol/salbutamol for at least 4 hours prior to study visits History of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 10 years. 2. Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1 and led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the subject's asthma status or the subject's ability to participate in the study. 3. Asthma Exacerbation: Any asthma exacerbation requiring oral corticosteroids within 12 weeks of Visit 1 or that resulted in overnight hospitalization requiring additional treatment for asthma within 6 months prior to Visit 1. 4. Concurrent Respiratory Disease: A subject must not have current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities other than asthma. 5. Other Concurrent Diseases/Abnormalities: A subjects must not have any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the patient at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study. 6. Oropharyngeal Examination: A subject will not be eligible for the run-in if he/she has clinical visual evidence of candidiasis at Visit 1. 7. Allergies: •Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the new powder inhaler (i.e., lactose or magnesium stearate). •Milk Protein Allergy: History of severe milk protein allergy. 8. Concomitant Medications: Use of the protocol defined prohibited medications prior to Screening (Visit 1) or during the study, in accordance with the protocol. 9. Tobacco Use: Current smoker or subjects with a smoking history of 10 pack years (e.g., 20 cigarettes/day for 10 years). A subject may not have used inhaled tobacco products within the past 3 months (i.e., cigarettes, cigars, smokeless or pipe tobacco). 10. Affiliation with Investigator's Site: A subject will not be eligible for this study if he/she is an immediate family member of the participating Investigator, Sub Investigator, study coordinator, or employee of the participating Investigator. 11. Previous Participation: A subject may not have previously been Randomized to treatment in another Phase III fluticasone furoate/VI combination product study (i.e., HZA113714, HZA106827, HZA106829, HZA106837, HZA106839, HZA106851, HZA113091). 12. Compliance: A subject will not be eligible if he/she or his/her parent or legal guardian has any infirmity, disability, disease, or geographical location which seems likely (in the opinion of the Investigator) to impair compliance with any aspect of this study protocol, including visit schedule and completion of the daily diaries
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 16.0-65.0, Asthma Outpatients aged between 16 years Male and female; female subjects must be non-child bearing potential or of childbearing potenetial with negative pregnancy test and willing to use acceptable contraceptive methods Documented clinical history of persistent asthma first diagnosed at least 6 months prior to Visit 1 Currently receiving inhaled short-acting beta-2 agonists for symptom relief A lung function of between 50 to 90% predicted (PEF) Increase in PEF of at least15%, 20 minutes after inhalation of 400mcg salbutamol History of respiratory tract infection and/or exacerbation of asthma within a period of 4 weeks prior to Visit 1 History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxia seizures A history of two or more asthma exacerbations requiring treatment with oral corticosteroids or hospitalisation in the 6 months before Visit 1 Past or present disease that, as judged by the investigator, may affect the outcome of this study. These diseases but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematologic disease, neurological disease, endocrine disease or pulmonary disease (including, but not confined to, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis and bronchopulmonary dysplasia) Known or suspected sensitivity to corticosteroids, or the constituents of (e.g., lactose) Undergoing allergen desensitisation therapy Neurological or psychiatric disease or history of drug or alcohol abuse that would interfere with the subject's proper completion of the protocol requirements Is a current smoker or has a smoking history of 10 pack years or more (e.g., 20 cigarettes/day for 10 years). Note: Current smoker is defined as currently smoking or stopped smoking within 6 months of screening visit
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 4.0-12.0, Asthma -Non-asthmatic group: healthy children from 4-12 years will be recruited from the Capital Institute of Pediatrics nearby schools 1. Willingly attend this investigation 2. Chest physical tests are normal The child had been hospitalized for any severe respiratory condition 2. A physician had ever stated that the child had asthma, reactive airway diseases, or the child had taken antiasthma medications for symptoms 3. The child was diagnosed with congenital heart disease requiring surgery or medications for management 4. There are positive responses concerning other serious chest problems, chest surgery, chronic productive cough, recurrent intractable wheezing, and shortness of breath 5. The children can not finish the test that met American Thoracic Society for preschool children in a maximum of 6 attempts and are unable to successfully complete post-bronchodilator (BD) spirometry Asthmatic group: 4-12 years old asthmatic children will be recruited from the asthma clinic of the Capital Institute of Pediatrics 1. Diagnose asthma by specialist of asthma (based on symptoms): for the diagnosis of asthma made by the asthma specialist included a history of recurrent coughing, wheezing, or shortness of breath at rest or with exercise, symptomatic improvement after bronchodilator use, and of other diagnoses 2. Asymptomatic or mild symptomatic with no physical signs of wheeze at the time of testing 3. Not receiving controller medication 6 weeks prior to the initial evaluation 4. Willing to attend this investigation Using short β2 agonists within 6 hours 2. Using long acting β2 agonists within 24 hours 3. Can not finish the test that met American Thoracic Society for preschool children in a maximum of 6 attempts and are unable to successfully complete post-bronchodilator spirometry
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-65.0, Asthma The following must be met for study entry (Part 1 Screening) Males and females between ≥ 18 and ≤ 65 years of age Able and willing to provide written informed consent to participate in the study, in accordance with ICH GCP requirements Non or ex-smoker, defined by an ex-smoker is defined as someone who completely stopped smoking for at least 12 months before Visit 1 of this study Able to adhere to study procedures In good general health without clinically significant medical history (see also below) Physical examination and laboratory results within the normal ranges, if not within the ranges, they must be without clinically significance within 28 days prior to dosing Available for follow-up for the duration of the study (i.e. up to 10 weeks, including the Screening and Treatment Phases) Mild to moderate, stable, allergic asthma by the ATS (1) History of episodic wheeze and shortness of breath; FEV1 at baseline at least 70% of the predicted value Males agree to practice adequate contraception throughout the duration of the study and up to one month after drug administration All females must have a negative serum pregnancy test at Screening Days -5 to -1 (Visit 5) and a negative urine pregnancy test at Day 1 of each Treatment Phase prior to dosing (Visits 6 and 11) A female patient must meet one of the following No reproductive potential, defined as: menopausal for at least two years or surgically sterile for at least six months (i.e. has undergone hysterectomy, bilateral oophorectomy or tubal ligation) OR Participant agrees to be heterosexually inactive from Screening Visit 1 until one month post final dose OR
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 7.0-65.0, Asthma Symptoms: Must have non-specific lower respiratory symptoms, such as cough, wheeze, and/or shortness of breath Age: Seven (7) to 65 years, inclusive Sex: Males and Females Ability to successfully perform assessment of FeNO: Investigators should use their judgment to determine if study candidates will be able to successfully perform assessment of FeNO using the NIOX MINO® Diagnosis: No previous or current diagnosis of asthma or chronic obstructive pulmonary disease (COPD) Medications: No use of inhaled or oral corticosteroids within 7 days prior to the visit Study Participation Outside of This Protocol: Patients currently enrolled in studies of Investigational or non-Investigational Drugs or Medical Devices and/or who participated in these studies within 30 days prior to this study are excluded
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-50.0, Asthma Viral Infection Age between 18 years History of episodic chest tightness and wheezing Intermittent or mild persistent asthma according to the by the Global Initiative for Asthma Non-smoking or stopped smoking more than 12 months ago and ≤ 5 pack years (PY) Clinically stable, no history of exacerbations within the last 6 weeks prior to the study Steroid-naïve or those patients who are currently not on corticosteroids and have not taken any corticosteroids by any dosing-routes within 2 weeks prior to the study. Occasional usage of inhaled short-acting beta2-agonists as rescue medication is allowed, prior and during the study Baseline FEV1 > 80% of predicted Airway hyperresponsiveness, indicated by a positive acetyl-ß-methylcholine bromide (MeBr) challenge with PC20 < 9.8 mg/ml Positive skin prick test (SPT) to one or more of the 12 common aeroallergen extracts, defined as a wheal with an average diameter of > 3mm Presence of antibodies directed against RV16 in serum (titer > 4), measured at visit 1 History of clinical significant hypotensive episodes or symptoms of fainting, dizziness, or light-headedness Women who are pregnant, lactating or who have a positive urine pregnancy test at visit 1 Chronic use of any other medication for treatment of lung disease other than short-acting beta2-agonists Participation in any clinical investigational drug treatment protocol within the preceding 3 months Ongoing use of tobacco products of any kind or previous usage with ≥ 6 total PY Concomitant disease or condition which could interfere with the conduct of the study, or for which the treatment might interfere with the conduct of the study, or which would, in the opinion of the investigator, pose an unacceptable risk to the patient People with young children (< 2 years)
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 6.0-14.0, Asthma Children with physician diagnosed asthma aged 6 years -14 years, 11months Those requiring frequent short-acting beta2 agonist relief therapy ≥ 7 puffs in the past seven days Those with symptoms of asthma (i.e. wheeze, shortness of breath but not cough alone) resulting in: i. Nocturnal wakening in the last week because of asthma symptoms and/or ii. Asthma has interfered with usual activities in the last week and/or iii. Those who have had exacerbations, defined as a short course of oral corticosteroids, an unscheduled GP or A&E Department visit or a hospital admission within the previous 6 months Fully informed written (proxy) consent and assent, where appropriate Children receiving long acting beta2-agonists, leukotriene receptor antagonists, regular theophylline therapy or high dose ICS >1000micrograms and unlicensed beclometasone dipropionate or equivalent (at the discretion of the investigator) Children with other respiratory diseases, cystic fibrosis, cardiac disease or immunological disorders Non-English speaking
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-65.0, Asthma A subject will be eligible for in this study only if all of the following apply ALT, alkaline phosphatase and bilirubin less than or equal to 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) Single QTc, QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent A female subject is eligible to participate if she is of Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<147 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the protocol approved contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks should elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method Child-bearing potential and is abstinent or agrees to use one of the protocol approved contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until the follow-up visit Capable of giving informed consent, which includes compliance with the study requirements and restrictions listed in the consent form BMI within the range 18 and 35 kg/m2 (inclusive) A subject will not be eligible for in this study if any of the following apply: Medical Condition Exclusions Subjects who have a current diagnosis or a history of asthma, excluding childhood asthma which has been discharged by physician (e.g., for any FTIH where risk of bronchoconstriction is unknown, or compound specific where risk of bronchoconstriction). This must be documented in the subject's medical notes Subjects who have a current and previous diagnosis of COPD. This must be documented in the subject's medical notes Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening A positive test for HIV antibody Pregnant females as determined by positive serum hCG test at screening or prior to dosing Lactating females Subject is mentally or legally incapacitated Unwillingness or inability to follow the procedures outlined in the protocol. Medical Exclusions
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease Patients with moderate COPD (Stage II) Able to perform spirometry assessments Current or ex-smokers On treatment with the fixed-dose combination of salmeterol 50 µg/fluticasone propionate 500 µg MDDPI b.i.d. for the treatment of COPD for ≥ 3 months directly preceding Visit 1 Having had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the past year Having a history of, or current ECG abnormality Asthma Other protocol-defined inclusion/
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 21.0-999.0, Coronary Artery Disease Angina Pectoris Chest Pain Cardiovascular Diseases Coronary Heart Disease CAD CVD CHD Patients with symptoms suggestive of CAD, including typical or atypical angina or angina equivalent 2. The patient has signed the appropriate Institutional Review Board approved Informed Consent Form History of myocardial infarction 2. Current MI or acute coronary syndrome 3. Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms 4. Any previous coronary Revascularization 5. Any individuals with Diabetes Suspected unstable angina Systemic infections Systemic inflammatory conditions 6. Any individuals currently taking Steroids Immunosuppressive agents Chemotherapeutic agents 7. Recipient of any organ transplant
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 14.0-999.0, Heart Failure Community Acquired Pneumonia Venous Thromboembolism Acute Kidney Injury Asthma (Overall Criteria) One principle diagnosis Hemodynamic Stability 2. (Specific to each Diagnosis): Acute Venous Thromboembolism New onset / in-patient Acute Kidney Injury Patients with increased serum creatinine of more than 50% from baseline Community Acquired Pneumonia Age limit Adult Left Ventricular Heart Failure Age limit Asthma Acute exacerbation of Asthma 3 (Overall Criteria) Intensive Care Unit (ICU) patients Pregnancy 4 (Specific to each Diagnosis): Acute Venous Thromboembolism Hemodynamic instability (Systolic Blood Pressure (SBP) less than 90 mmHg or massive Pulmonary Embolism (PE) PE patients with an sPESI Score ≥ 1 Acute Kidney Injury Critical care patients (ICU, Coronary Care Unit, burn units) Stage 4 and 5 chronic kidney diseases Kidney allograft recipients Obstructive uropathy
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-65.0, Asthma asthma (according to British Thoracic Society guideline) >18 years pregnancy systemic disease with nasal manifestations cancer of the nose currently receiving cancer therapy previous nose surgery
|
2
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 12.0-999.0, Asthma Written informed consent/assent signed and dated by the subject and/or parent /legal guardian before conducting any study related procedure. 2. Male or female 12 years and older, as of the Screening Visit. Male or female 18 years and older, as of the Screening Visit, in countries where local regulations or the regulatory status of study medication permit enrollment of adults only. 3. General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the subject at increased risk during the study. 4. Asthma Diagnosis: Asthma as defined by the National Institutes of Health (NIH). 5. Severity of Disease: • A best forced expiratory volume in one second (FEV1) of 40%-85% of the predicted normal value during the Screening Visit. III predicted values will be used for subjects aged ≥12 years and adjustments to predicted values will be made for African American subjects. ATS/ERS 2005 for acceptability, reproducibility, and end of test must be met for spirometry 6. Reversibility of Disease: Demonstrated a ≥12% reversibility of FEV1 within 30 minutes following 2 inhalations of albuterol/salbutamol inhalation aerosol (if required, spacers are permitted for reversibility testing only) at the Screening Visit. If a subject fails to demonstrate an increase in FEV1 ≥12% then the subject is not eligible for the study and will not be allowed to re-screen. Reversibility values of 11.50 - 11.99 will be rounded to 12. Documented historical reversibility of ≥ 12 % within 3 months of the Screening Visit will be accepted. 7. Current Asthma Therapy: Subjects will be required to be on a short acting β2 agonist and inhaled corticosteroid for a minimum of 8 weeks before the Screening Visit and have been maintained on a stable dose of inhaled corticosteroids for four weeks prior to the Screening Visit at one of the following doses Fluticasone propionate HFA MDI ≥ 880 mcg/day Fluticasone propionate DPI≥ 1000 mcg/day Beclomethasone dipropionate DPI ≥ 2000 mcg/day Beclomethasone dipropionate HFA (QVAR)≥ 640 mcg/day Beclomethasone dipropionate HFA (Clenil Modulite)≥ 2000 mcg/day Budesonide DPI ≥ 1600 mcg/day Budesonide MDI ≥ 1600 mcg/day Flunisolide ≥ 2000 mcg/day Triamcinolone acetonide ≥ 2000 mcg /day History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures. 2. Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks of the Screening Visit. In addition, the subject must be excluded if such infection occurs between the Screening Visit and the Randomization Visit. 3. Any asthma exacerbation requiring oral corticosteroids within 1 month of the Screening Visit. A subject must not have had any hospitalization for asthma within 2 month prior to the Screening Visit. Note: An exacerbation of asthma is defined as any worsening of asthma requiring any treatment other than rescue albuterol/salbutamol HFA MDI and/or the subject's regular inhaled corticosteroid maintenance treatment. This includes requiring the use of systemic corticosteroids and/or emergency room visit or hospitalization, a change in the subject's regular inhaled corticosteroid maintenance treatment, or the addition of other asthma medications. 4. Presence of glaucoma, cataracts, ocular herpes simplex, or malignancy other than basal cell carcinoma. 5. Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (e.g., congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia or coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine (e.g., uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), gastrointestinal (e.g., poorly-controlled peptic ulcer, GERD), or pulmonary (e.g., chronic bronchitis, emphysema, bronchiectasis with the need for treatment, cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which could affect the efficacy or safety analysis if the disease/condition exacerbated during the study. 6. Have any of the following conditions that, in the judgment of the investigator, might cause participation in this study to be detrimental to the subject, including, but not limited to Current malignancy excluding basal cell carcinoma; History of malignancy is acceptable only if the subject has been in remission for one year prior to the Screening Visit. (Remission is defined as no current evidence of malignancy and no treatment for the malignancy in the 12 months prior to the Screening Visit) Current or untreated tuberculosis; History of tuberculosis is acceptable only if a subject has received an approved prophylactic treatment regimen or an approved active treatment regimen and has had no evidence of active disease for a minimum of 2 years Uncontrolled hypertension (systolic BP ≥160 or diastolic BP >100) Stroke within 3 months prior to the Screening Visit Immunologic compromise 7. History of a positive test for HIV, hepatitis B or hepatitis C infection. 8. Untreated oral candidiasis at the Screening Visit. Subjects with clinical visual evidence of oral candidiasis and who agree to receive treatment and comply with appropriate medical monitoring may enter the study 9. History of any adverse reaction to any intranasal, inhaled or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the dry powder inhalers (Spiromax or Diskus) used in the study (i.e., lactose). 10. History of severe allergy to milk protein. 11. Use of systemic, oral or depot corticosteroids within 4 weeks prior to the Screening Visit Use of topical corticosteroids (≤1% hydrocortisone cream) for dermatological disease is permitted Use of intranasal corticosteroids or ocular corticosteroids at a stable dose for at least 4 weeks prior to the Screening Visit and throughout the study is permitted 12. Use of immunosuppressive medications within 4 weeks prior to the Screening Visit and during the study. 13. Immunotherapy for the treatment of allergy at a stable maintenance dose for at least 90 days prior to the Screening Visit and which will remain at a stable dose without escalation throughout the study is permitted. 14. Use of Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, ketoconazole, itraconazole) within 4 weeks prior to the Screening Visit. Strong and moderate CYP3A4 inhibitors are prohibited and weak CYP3A4 are allowed. 15. History of alcohol or drug abuse within two years preceding the Screening Visit. 16. Current smoker or a smoking history of 10 pack years or more (a pack year is defined as smoking 1 pack of cigarettes/day for 1 year). A subject may not have used tobacco products within the past one year (e.g., cigarettes, cigars, chewing tobacco, or pipe tobacco). 17. Study participation by clinical investigator site employees and/or their immediate relatives. 18. Study participation by more than one subject from the same household at the same time. However, after the study completion or discontinuation by one subject another subject from the same household may be screened. 19. Participation in any investigational drug study within the 30 days (starting at the final follow-up visit) preceding the Screening Visit or planned participation in another investigational drug study at any time during this study. 20. Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the subject's last study related visit (for eligible subjects only if applicable). Eligible female subjects unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study will be excluded
|
2
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 19.0-92.0, COPD Men of ages 18 and 30 (Dates of birth 1973-1985) or 55-92 years old (Dates of birth 1911-1948). 2. Must not currently be a cigarette smoker. If an ex-smoker then has not smoked for at least 10 years and consumption were no more than 10 pack years. 3. Agrees to volunteers for the study and willing to sign the informed consent form. 4. There were negative/normal screening tests for the following 1. Responses to the questionnaire deny current and prior respiratory diseases (including asthma, emphysema, chronic bronchitis, sinusitis and interstitial lung d9sase) and no current respiratory complaints (e.g., cough, wheezing, shortness of breath, allergic rhinitis, and sinusitis). Subjects must not be taking any cardiac medications or admit to a physician-diagnosed cardiac condition. 2. "Normal" spirometry measurements with FEV1 & FVC greater than 75% predicted and FEV1/FVC more than 69% 3. Impedance oscillometry were within normal limits 4. "Negative" physical examination of the chest with absence of wheezing and crackles on auscultation of the chest. 5. Exhaled nitric oxide concentration is less than 35 ppb for younger and less than 65 ppb for older groups men of: ages < 18, 31-54 and >92 years old; 2. current cigarette smokers or exsmokers who have smoked within the past 10 years and/or smoked more than 10 pack/years; 3. refusal to volunteer for the study and not willing to sign the informed consent form; 4. screening test not considered "normal" by physician/PI and showing one or more of the following: 1. one or more positive response to the questionnaire(e.g., current or past respiratory diseases including asthma, emphysema, chronic bronchitis, sinusitis and interstitial lung disease; and/or; current respiratory complaints (e.g., cough, wheezing, shortness of breath, allergic rhinitis, and sinusitis) and/or; admitting to taking a cardiac medication and/or; or physician-diagnosed cardiac condition (e.g., coronary heart disease, angina, myocardial infarction, valvular heart disease, cardiomyopathy, etc.); 2. Abnormal spirometry measurements (FEV1 &/or FVC <75% predicted and FEV1/FVC <69%); 3. "Positive" physical examination (performed by Physician/PI) with presence of wheezing and/or crackles on auscultation of the chest; 4. Impulse oscillometry >4 times normal limits; 5. Exhaled nitric oxide of >35ppb for younger group and >65 ppb for older group. -
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 6.0-999.0, Filariasis Age 6 years or older of either gender 2. Patients presenting with pulmonary symptoms a. Confirmed or suspected asthma patients: i. Patients presenting with symptoms consistent with an acute exacerbation of asthma, including: 1. Wheezing 2. Shortness of breath 3. Chest tightness 4. Cough ii. Disposition to the asthma room after triage and physician evaluation (disposition to other areas of the A&E allowed if due to no available space in the asthma room) iii. Patients are potentially eligible with or without a past history of health care provider diagnosed asthma iv. Patients are potentially eligible regardless of the number of previous episodes of wheezing (i.e. patients with a first episode of bronchospasm are potentially eligible) v. If suspected or documented to have pneumonia or a pulmonary infiltrate, patients are potentially eligible if: 1. They have a dry cough (no production of purulent sputum) 2. They have bronchospasm as manifested by wheezing or need for salbutamol (albuterol) breathing treatments vi. Patients with wheezing are not eligible if they: 1. Have purulent sputum production 2. Have known or suspected: a. Tuberculosis b. Immunodeficiency c. Congestive heart failure d. Foreign body aspiration b. Patients presenting with a chief complaint of cough: i. Potentially eligible patients will have a cough of greater than one week (seven days) duration ii. Asthma room disposition is not required for these subjects iii. If suspected or documented to have pneumonia or a pulmonary infiltrate, patients are potentially eligible if: 1. They have a dry cough (no production of purulent sputum) iv. Patients with cough are not eligible if: 1. Have purulent sputum production 2. Have known or suspected: 1. Tuberculosis 2. Immunodeficiency 3. Congestive heart failure 4. Foreign body aspiration 3. Patients will be medically stable at the time of the consent process (see below) 4. A minimum of 2 years of continuous residence in Guyana at the time of enrollment, exclusive of short trips out of the country (at least 21 of previous 24 months physically in Guyana) 5. English speaking Patients less than 6 years of age 2. Patients who do not consent to the study 3. Children (<18 years) without a parent/guardian present 4. Prisoners 5. Patients who appear to be medically or psychologically unstable or felt to be otherwise inappropriate for study enrollment, in the opinion of the investigator or any treating health care provider. This determination will be made on an individual basis, but some of the general to be used in making this determination will be: i. The patient appears to be in significant pain ii. The patient appears acutely ill - severe respiratory distress, diaphoretic, altered mental status, active bleeding, actively vomiting, etc. iii. Those with respiratory difficulty to the point they cannot speak in complete sentences iv. Chief complaint of sexual assault v. The patient appears acutely intoxicated vi. The patient displays agitated, nervous, restless, or other behavior suggestive of an uncontrolled psychiatric emergency 6. Patients with pulmonary findings felt to be secondary to congestive heart failure, foreign body, bacterial pneumonia, tuberculosis or other clearly defined cause 7. Non-English speaking patients 8. Patients without at least 2 years of residence (exclusive of short trips abroad, total of 21 of 24 previous months physically in Guyana) in Guyana at the time of enrollment
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 1.0-5.0, Asthma All patients' parents (or legal guardians) must sign and date an informed consent consistent with ICH-GCP guidelines and local legislation prior to participation in the trial. Where appropriate, participants should assent to enroll in the study. 2. Male or female patients between 1 and 5 years of age. 3. By a physician documented (at least 6 month) history of persistent asthma symptoms, including (but not limited to) wheezing, cough, and/or shortness of breath. (persistent = need for inhalation corticosteroid maintenance therapy to control asthma symptoms) 4. For patients aged 5 years and capable of performing technically acceptable Pulmonary Function tests (PFTs): documented impaired lung function (i.e. pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) is smaller or equal to 90% of predicted normal). 5. All patients must have been on maintenance treatment with an inhaled corticosteroid at stable dose, either as mono treatment or in combination with another controller medication, for at least 4 weeks before Visit 1. 6. All patients must be symptomatic (partly controlled) as defined by the Global Initiative for Asthma (GINA) guideline for children aged 5 years and younger in the week prior to Visit 1 (screening) and in the week prior to randomisation (Visit 2). Further apply Patients with a significant disease other than asthma. 2. Patients with clinically relevant abnormal screening haematology or blood chemistry will be excluded if the abnormality defines a significant disease as defined in criterion 1. 3. Patients with a history of congenital or acquired heart disease, or patients who have been hospitalised for cardiac syncope or failure during the past year. 4. Patients with any unstable or life-threatening cardiac arrhythmia, including cardiac arrhythmia requiring intervention (e.g. pacemaker implantation) or a change in drug therapy within the past year. 5. Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy. 6. Patients with clinically significant lung diseases other than asthma. 7. Alternative causes (other causes than asthma) that can lead to respiratory symptoms of wheeze, cough and shortness of breath. 8. Patients with known active tuberculosis. 9. Patients who have undergone thoracotomy with pulmonary resection. 10. Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to the screening visit (Visit 1). Further apply
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-65.0, Asthma Age between 18-65 years inclusive Written informed consent (conducted according to the GCP and ICH guidelines) to participate in the study. Ability to comply with all study requirements Mild to moderate persistent asthma with symptoms at least 2 times per week, managed by as-needed SABA only A 35% or greater improvement in small airway dysfunction defined by IOS AX after inhaled SABA Allergic response to one or more common allergens at screening via skin test Male, or female of childbearing potential using a medically approved birth control method Evidence of SAD manifested by an index of peripheral airway reactance of > 10.5 cm H2O/L (3 times the upper limit of adult normal) Symptoms of airflow obstruction (i.e. dyspnea on exertion greater than peers at similar exercise levels, wheeze, or cough > 3 weeks without respiratory infection, or nocturnal dyspnea, and use of SABA > 2 times per week) Subjects with severe persistent asthma and/or subjects taking inhaled or systemic corticosteroids or long acting beta agonists (LABA) Subjects < 18 years of age or > 65 years Pregnant or lactating females History of diabetes Acute infections within 4 weeks prior to Screening Concurrent medical condition that might interfere with the interpretation of efficacy and safety data during the study Contraindications and warnings according to the specific label for Asmanex Chronic inhaled or systemic corticosteroid treatment (> 7 consecutive days of treatment) within 30 days prior to Screening Investigational drug treatment within 30 days prior to Screening. Treatment with any drug with a known and frequent toxicity to a major organ system within the past 60 days
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 8.0-50.0, Cystic Fibrosis Cooperation with spirometry exacerbation, patients younger than 8 years
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-80.0, Asthma asthma not well control COPD
|
2
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-64.0, Seasonal Allergic Rhinitis History and diagnosis of seasonal allergic rhinitis by skin prick test Have nasal symptom scores as defined by the study protocol Able to comply with study procedures Any nasal disease or abnormality, active respiratory tract infections within the past 2 weeks, or recent nasal surgery or sinus surgery at Screening Use of any prohibited concomitant drugs or therapies
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-80.0, Psoriatic Arthritis Age 18-80 active psoriatic arthritis (joint or enthesis inflammation) Diabetes pregnant no active PsA
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-65.0, Asthma Cough Individuals aged 18-65 years of age with asthma, CVA and individuals with methacholine-induced cough but normal airway sensitivity. The following definitions will be used: 1. asthma: episodic respiratory symptoms occurring in association with variable airflow obstruction (Canadian Asthma Consensus Report definition); 2. CVA: chronic cough (≥8 weeks) is the sole or predominant symptom and positive methacholine challenge (PC20 ≤ 16 mg/mL) and history of cough responding to specific asthma treatment (such as inhaled steroid or 1 week trial of bronchodilator); 3. Methacholine-induced cough but normal airway sensitivity: chronic cough (≥8 weeks) is the sole or predominant symptom and negative methacholine challenges (PC20 > 16 mg/mL) Individuals aged 18-65 years of age with no history of asthma or chronic cough an exacerbation necessitating a change in medication, emergency department visit or hospitalizations within the previous 4 weeks inability to perform acceptable spirometry medical contraindications to methacholine challenge testing 1. Severe airflow limitation (FEV1 <50% predicted or <1.0 L); 2. Heart attack or stroke in last 3 months; 3. Uncontrolled hypertension, systolic BP > 200 or diastolic BP > 100; 4. Known aortic aneurysm; 5. Moderate airflow limitation <60% predicted or 1.5) is a relative contraindication; 6. Inability to perform acceptable quality spirometry; 7. Current use of cholinesterase inhibitor medication (for myasthenia gravis); and 8. Pregnant or nursing mothers smoking history in excess of 10 pack years Note: Previous treatment with inhaled or systemic corticosteroids is not an criterion; medication use will be recorded and examined in the analysis
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-89.0, Dyspnea Subjects are included if they are between the ages of 18-89 and present to the Emergency Department with a chief complaint of shortness of breath or dyspnea known history of asthma are 20 or more weeks pregnant, or have had thoraco-abdominal trauma in the past 72 hours
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-60.0, Asthma Aspirin-sensitive ASA Intolerant Asthma Asthma, Aspirin-Induced Asthma, Nasal Polyps, and Aspirin Intolerance Persons between 18 and 60 years of age Suspected Acetylsalicylic Acid Hypersensitivity History on anaphylactic shock after intake History on gastric ulcer after intake Patients previously gone through testing or desensitisation for Aspirin hypersensitivity Clinical unstable asthma or baseline FEV1<70% Severe disease of the heart, digestive tract, liver or kidney Severe chronic urticaria Present conjunctivitis Pregnancy
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 17.0-70.0, Asthma Chinese male or female outpatients aged >=17 years and <=70 years A female is eligible to enter and participate in this study if she is: Non-childbearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchal, post-menopausal), or Child-bearing potential, has a negative urinary pregnancy test at screening and agrees to take contraceptive precautions (including abstinence) (referring to appendix 1: Highly Effective Methods For Avoidance Of Pregnancy In Women Of Childbearing Potential) which, in the opinion of the investigator are adequate to prevent pregnancy during the study A documented clinical history of asthma for a period of at least 12 weeks prior to Visit 1 based on the Guidance of Asthma Management and Prevention 2008 in China (refer to appendix 2) Demonstrated >=12% and >=200mL reversibility of FEV1 within 15-30minutes following inhalation of 200-400ug of salbutamol aerosol within 12 months prior to visit 1 or at the Screening Visit Subjects have pre-bronchodilator FEV1% predicted between >=40% and <80% at visit 1 Subjects on a stable dose at least 2 weeks with high dose ICS (eg. Fluticasone Propionate 500ug twice daily or other ICS with equivalence doses, refer to Appendix 3) or moderate dose ICS plus LABA (eg. Fluticasone Propionate/Salmoterol 250/50ug , twice daily; or Budesonide/Formoterol Fumarate in maintainance160/4.5ug, two inhalation, twice daily; or other product equivalence doses) Subjects and/or their legally acceptable representative (if applicable) is willing to give informed consent to participate in the study, and having ability to comply with study procedures (including patients can use Nebulizer correctly, be able to understand and complete the diary cards and be able to record their PEF using a peak flow meter). The subjects and/or their legally acceptable representative (if applicable) will need to give additional informed consent to be eligible for blood pharmacokinetic samplings History of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures Bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of visit 1 and led to a change in asthma management or, in the opinion of the investigator, is expected to affect the subject's asthma status or the subject's ability to participate in the study A subject must not have current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities other than asthma Subjects have any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the patient at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study Subjects will not b eligible for the run-in if he/she has clinical visual evidence of candidias at visit 1 Current smoker or a smoking history of 10 pack years or more. A subject may not have used inhaled tobacco products (i.e., cigarettes, cigars or pipe tobacco) within the past 3 months Patients who are pregnant or lactating Patients having any known or suspected hypersensitivity to corticosteroids or the excipients of study drug, including Polysorbate 20, Sorbitan monolaurate, Monosodium phosphate dehydrate, Dibasic sodium phosphate anhydrous, Sodium Chloride and Water for Injection Patients who have evidence of alcohol abuse Patients who will have a pre-planned surgery operation in 6 months
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-150.0, Asthma Men and women aged 18 years and above. Females of childbearing potential must use a highly effective contraceptive method plus a condom by their male partner Diagnosis of asthma for at least 12 months (GINA 2011) Uncontrolled persistent asthma, despite treatment with medium to high dose ICS and LABA, and with a history of exacerbations during the last year Morning prebronchodilator FEV1 of ≥30% and ≤85% predicted normal at enrolment Daily use of medium or high dose ICS (≥fluticasone 500 µg or the equivalent daily) Any clinically significant disease or disorder (including any chronic lower respiratory disease other than asthma) that may put the patient at risk or influence study results Patients with recurrent, latent, or chronic infections Active tuberculosis or latent tuberculosis without completion of an appropriate course of treatment or prophylactic treatment Significant lower respiratory tract infection not resolved within 30 days prior to enrolment Current smoker or smoking history of more than 20 pack years
|
2
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 20.0-999.0, Pulse Spectrum Analysis Pulmonary Function FeNO Metabolites Meet the diagnostic of GINA guideline asthma patients Cancer or immune impaired patients pack-year smoking> 5 long-term ventilator-dependent patients Control group: 30 age matched healthy controls
|
2
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 6.0-11.0, Nasal Congestion Associated With the Common Cold Male or female subjects, ages 6 through 11 years, are experiencing the common cold, but are otherwise healthy. 2. Subjects have an onset of cold symptoms within the past 2.5 days before screening and are experiencing self-reported nasal congestion of at least stuffy severity (score = 3 or 4). 3. Subjects have at least two of the following additional symptoms due to common cold: runny nose, sneezing, sore throat, headache, body achiness, and cough, as deemed by the parent. 4. Subjects can swallow oral tablets without chewing them (based on a pretest of successfully swallowing a placebo tablet at screening) 5. Findings from the medical history review and vital signs are within the range of clinical acceptability, as determined by the investigator. 6. Subject and legally authorized representative are likely to be compliant and complete the study. 7. Subject's legally authorized representative has signed and dated the informed consent form. Subject has given verbal assent, and has signed and dated the informed assent form. 8. Female subjects who have reached menarche must have a negative urine pregnancy test at screening. These subjects must have practiced abstinence for at least three months prior to study entry and for the duration of the study. A second pregnancy test will be given when the subject returns to the clinic after the last dose. 9. Subject and legally authorized representative can read and understand English. 10. Subject's legally authorized representative who signs informed consent is available to administer all assessments and study medication on days 1 and 2 Have any of the following medical conditions: heart disease, high blood pressure, thyroid disease, diabetes, peripheral vascular disease, increased intraocular pressure, prostatic hypertrophy 2. Are under treatment for a hyperexcitability disorder with a medication regimen that has not been stable for at least 3 months 3. Are currently experiencing an asthmatic episode 4. Are experiencing symptoms of seasonal or perennial allergic rhinitis 5. Are currently or within the last 24 hours having symptoms of vomiting or diarrhea 6. Have been exposed to immediate family members with the flu within the past week 7. Are exhibiting signs or symptoms of, or diagnosed with sinusitis, pneumonia, strep throat, acute otitis media, or influenza 8. Are experiencing a fever 103˚F or higher at screening 9. Are from homes where there is smoking in the home around the child. 10. Are currently taking a monoamine oxidase inhibitor (MAOI), or have taken a MAOI within two weeks of screening (e.g., isocarboxazid Marplan, phenelzine Nardil, selegiline Eldepryl, Emsam, Zelapar, and tranylcypromine Parnate). Note: subjects may not discontinue taking a MAOI solely of the purposes of qualifying for the study. 11. Have a known sensitivity or allergy to pseudoephedrine, phenylephrine, or acetaminophen or any of the excipients of the drug product 12. Have taken any oral cold or allergy medicine within 12 hours of enrollment, or intranasal decongestants within 24 hours of enrollment except for single-ingredient OTC analgesics 13. Have the need to take additional medications, including cough and cold (i.e., oral or intranasal antihistamines, intranasal steroids, intranasal decongestants), or herbal/dietary supplements during the study, with the exception of acetaminophen, a medication regimen for a hyperexcitability disorder that has been stable for at least three months or a daily vitamin or multivitamin/multimineral supplement 14. Have participated in another clinical study within 30 days before entry 15. Have another child from the household currently participating in this study 16. Have a history of drug, alcohol, or tobacco use (older children) 17. Are involved directly or indirectly with the conduct and administration of this study (i.e., children of principal investigator, subinvestigator, study coordinators, other study personnel, employees of Perrigo, and the families of each)
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-999.0, Halitosis Caucasian Age ≥ 18 years Organoleptic score of breath ≥ 2 VSC readings (sum of H2S and CH3SH by OralChroma) ≥ 120 ppb* Intra-oral cause of bad breath Non-smokers Willing to participate and able to give written informed consent Ongoing dental treatment or any other medical treatment of the oral cavity Any known allergy to previously used oral hygiene products or any known allergy to any of the ingredients of the study products, which are used during the study Any pathological change of the oral mucosa Use of prohibited treatments / therapies and/or abuse of drugs, alcohol, etc Pregnancy or breastfeeding Active caries Acute sinusitis Severe oro-pharyngeal infections On medications which can cause malodour Reduced salivary flow due to pathological reasons (e.g. Sjögren syndrome)
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 4.0-15.0, Asthma Grades K-8 the school year following spring recruitment (Ages 4-15) Attend one of the schools in the fall where permission obtained for classroom sampling Able to provide assent and parent/guardian able to provide informed consent Physician-Diagnosed asthma AND Wheezing in the previous 12 months Significant pulmonary diseases other than asthma that might influence test results or pose risks (e.g., cystic fibrosis, sarcoidosis, bronchiectasis) Cardiovascular disease that requires daily medication Taking a beta blocker Active smoker Unable to follow through with study visit or complete study procedures
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 15.0-60.0, Bronchial Asthma Aged 15-60 years, male or female. 2. Mild to moderate persistent asthma. 3. Mini AQLQ score ≤6 or ACQ score ≥1. 4. Giving written informed consent Current smoker or quitted smoking ≤12 months. 2. Significant allergen exposure. 3. Respiratory tract infection within 2 weeks before or during the study. 4. Cardiovascular disease. 5. History of malignant disease within the preceding 5 years. 6. And/or concomitant pulmonary disease. 7. Pregnant or breast-feed period. 8. Use of leukotrienes receptor antagonist within 5 days
|
2
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-65.0, Asthma Male and female volunteers 18 through 65 years of age General good health Mild to moderate, stable, allergic asthma History of episodic wheeze and shortness of breath; FEV1 at baseline at least 70% of the predicted value Able to understand and give written informed consent and has signed a written informed consent form approved by the investigator's REB Positive methacholine challenge Positive skin-prick test to common aeroallergens (including cat, dust mite, grass, pollen) Positive allergen-induced airway bronchoconstriction (a fall in FEV1 of at least 20% from baseline) A worsening of asthma or a respiratory tract infection within 6 weeks preceding study entry Use of corticosteroids, immunosuppressives, anticoagulants (warfarin or heparin) within 28 days prior to randomization into the study Use of nonsteroidal anti-inflammatory drugs (NSAIDs) within 48 hours of dosing or aspirin with 7 days of dosing Have chronic use of any other medication for treatment of allergic lung disease other than short and intermediate-acting ß2-agonists or ipratropium bromide Use of caffeine-containing products or medications for 12 hours or alcohol or over the counter drugs including aspirin, cold and allergy medications for 48 hours or inhaled bronchodilators for 8 hours prior to methacholine and allergen challenges Use of tobacco products of any kind currently or within the previous 12 months, or smoking history > 10 pack years Lung disease other than mild to moderate allergic asthma Unwillingness or inability to comply with the study protocol for any other reason
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Type of subject: Outpatient Informed Consent: A signed and dated written informed consent prior to study participation Age: Subjects 40 years of age or older at Visit 1 Gender: Male or female subjects. A female is eligible to enter and participate if of non-child-bearing potential, or if of child bearing potential, has a megative serum pregnancy test at screening, and agrees to one of the acceptable contraceptive methods listed in the protocol, used consistently and correctly Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society Smoking History: Current or former cigarette smokers with a history of cigarette smoking of ≥10 pack-years [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Pipe and/or cigar use cannot be used to calculate pack year history Severity of Disease: A pre and post-albuterol/salbutamol FEV1/FVC ratio of <0.70 and a pre and post-albuterol/salbutamol FEV1 of ≤70% of predicted normal values at Visit 1 (Screening) calculated using Nutrition Health and Examination Survey (NHANES) III reference equations Dyspnea: A score of ≥2 on the mMRC Dyspnea Scale at Visit 1 -Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study Asthma: A current diagnosis of asthma Other Respiratory Disorders: Known α-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions. A subject who, in the opinion of the investigator, has any other significant respiratory conditions in addition to COPD should be excluded. Examples may clinically significant bronchiectasis, pulmonary hypertension, sarcoidosis, or interstitial lung disease Other Diseases/Abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled and/or a previous history of cancer in remission for <5 years prior to Visit 1 (localized carcinoma of the skin that has been resected for cure is not exclusionary). Significant is defined as any disease that,in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study Contraindications: Any history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist, sympathomimetic, corticosteroid (intranasal, inhaled or systemic) lactose/milk protein or magnesium stearate, or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of an inhaled anticholingeric Hospitalization: Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1 Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Visit 1 Lead ECG: An abnormal and significant ECG finding from the 12-lead ECG conducted at Visit 1. Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. Specific ECG findings that preclude subject are listed in Appendix 4. The study investigator will determine the medical significance of any ECG abnormalities not listed in Appendix 4 Medication Prior to Spirometry: Unable to withhold albuterol/salbutamol for the 4 hour period required prior to spirometry testing at each study visit Medications Prior to Screening: use of certain medications for the protocol-specific times prior to Visit 1. Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day. As-needed oxygen use (i.e., ≤12 hours per day) is not exclusionary
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 12.0-999.0, Asthma Written informed consent/assent General good health Diagnosis of asthma as defined by the National Institutes of Health (NIH) A best FEV1 of 40%-85% of the predicted normal value during the screening visit (SV) Subjects need to demonstrate a ≥ 15% reversibility of FEV1 within 30 minutes following 4 inhalations of albuterol inhalation aerosol (if required, spacers are permitted for reversibility testing) at the SV Other apply History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks prior to the SV Any asthma exacerbation requiring oral corticosteroids within 3 months of the SV. A subject must not have had any hospitalization for asthma within 6 months prior to the SV Taking long-acting β-agonists within 2 weeks of the SV Other apply
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-65.0, Allergic Rhinitis Asthma Age between 18 to 65 years of age Physician diagnosis of mild asthma based on the NIH guidelines Physician diagnosis of allergic rhinitis and confirmed by at least 3+ skin test response to at least one allergen Evidence of abnormal, reversible airway function on impulse oscillometry Ability to cooperate in measurement of impulse oscillometry Treatment with inhaled or oral corticosteroids within one month of screening visit Change in dosage of intranasal corticosteroids, or oral anti leukotrienes within one month of screening visit. Subjects on constant dose of intranasal corticosteroids or anti-leukotrienes for one month or more will be allowed in the study Known history of reflux, lung disease, or congenital heart disease Known history of adverse reaction to cetirizine
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 6.0-18.0, Asthma Children with decreased FEV1 (>=10% from baseline) and/or children with EIB history within last 12 months (symptoms: dyspnea, cough, wheezes, chest pain during/after exercises) Children without decreased FEV1 (>=10% from baseline) and/or children without EIB history within last 12 months (symptoms: dyspnea, cough, wheezes, chest pain during/after exercises)
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-90.0, Asthma COPD Patients (newly diagnosed or not) with asthma and / or COPD, who use correctly (according to the opinion of the responsible investigator) their device Male or female patients aged 18 years Patients with compliance to treatment Patients with compliance to the study procedures Patients who have signed the study participation consent form Patients who use incorrectly their inhalational devices Male or female patients under 18 years Patients who are non-compliant to their treatment for asthma and COPD Patients who are non-compliant to study procedures Patients who have not signed the study participation consent form
|
2
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-999.0, ASTHMA ALLERGIC RHINITIS Age of 18 years or older Diagnosis of asthma or allergic rhinitis, or both Planned initiation of treatment with ICS and/or INGC at study recruitment, according to routine clinical practice Use of inhaled, systemic or topical corticosteroids at study initiation, or during the previous 6 months Use of topical corticosteroid ointments or cream, or systemic corticosteroids during the study period Disorders associated with disruption of HPA axis (Cushing syndrome, Addison syndrome) Insufficient hair for analysis Bleaching or use of artificial hair color Pregnancy
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 12.0-999.0, Persistent Asthma Key 1. Written informed consent, and assent if applicable, must be obtained before any assessment is performed. 2. Male or female patients 12 years of age and older 3. Confirmed diagnosis of persistent asthma, as defined by national and international asthma guidelines (e.g., GINA; NIH; etc.) for at least 1 year prior to study enrollment. 4. PEF≥50% of predicted normal value. 5. Current and appropriate use of one of the treatments listed in the protocol for asthma. 6. Recent asthma exacerbation between 30 days and 12 months prior to randomization that either required treatment with systemic corticosteroids (tablets, suspension, or injection) or required hospitalization (defined as an inpatient stay or >24-hour stay in an observation area in an emergency room or other equivalent facility) Key History of life-threatening asthma episode that required intubation and/or was associated with hypercapnia requiring non-invasive ventilatory support. 2. Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia, or other respiratory abnormalities other than asthma. 3. Current evidence of, or past physician assessment of, chronic bronchitis, emphysema, or chronic obstructive pulmonary disease. 4. History of smoking ≥ 10 pack years. 5. Exercise induced asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine. 6. Suspected or documented bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved at randomization. 7. Worsening/Unstable asthma within 7 days prior to randomization. 8. Any asthma exacerbation requiring systemic corticosteroids within 30 days of randomization or more than 4 separate exacerbations in the 12 months preceding randomization. 9. Two or more hospitalizations for greater than 24 hours duration for treatment of asthma in the 12 months preceding randomization. 10. History of hypersensitivity to any beta2-agonist, sympathomimetic drug, inhaled corticosteroids, or systemic corticosteroid therapy or any component of the possible study treatments in this trial, including severe milk protein hypersensitivity. 11. Use of anti-IgE (e.g., omalizumab) or any other monoclonal antibody, in the 6 months prior to randomization. 12. Use of (Beta) β-blockers within 1 day prior to first dose of study medication. 13. Use of ICS, LABA, ICS+LABA, LTRAs, leukotriene modifiers, anticholinergics, or theophylline must be discontinued prior to the first dose of investigational treatment. 14. Use of a potent CYP3A4 inhibitor within 4 weeks of randomization (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin)
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-50.0, Asthma Age 18-50 of both genders 2. History of episodic wheezing, chest tightness, or shortness of breath after age of 6 years consistent with asthma, or physician diagnosed asthma after age of 6 years. 3. AND: Positive methacholine test. A positive test is defined as a provocative concentration of methacholine of 10 mg/ml or less producing a 20% fall in FEV1 (PC20 methacholine). Methacholine challenge in a separate screening protocol (98-0799), or from other venues will be accepted. 4. OR: Pre and post bronchodilator FEV1 improvement by 12% or more after 4 puffs of albuterol inhaler. 5. FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .70 (without use of bronchodilating medications for 12 hours), consistent with lung function of persons with no more than mild episodic or mild persistent asthma (NHANES III predicted set). 6. Allergic sensitization to at least one of the following allergen preparations: (House Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1, Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive immediate skin test response in a separate screening protocol. Proof of allergy from other venues, including ImmunoCAP testing from a medical workup, provided by the subject, will be accepted. 7. Oxygen saturation of > 94 % and normal blood pressure (Systolic between 150 Diastolic between 90-60 mm Hg) 8. Willing to provide information regarding health history and habits of cigarette smoke exposure; 9. Willing to avoid antioxidant vitamins and cruciferous vegetables as well as juices/drinks with added vitamin supplements for 2 days prior the baseline screening visit and throughout initial dosing period. 10. Subjects must be willing to avoid antihistamine use for 4 days prior to each session and NSAIDs for 7 days prior to each session. Nasal steroids must be held for 2 weeks prior to the session Medical history or underlying health problems that preclude participation in the protocol per the study physician; 2. Current nutritional disorder such as anorexia, bulimia, irritable bowel syndrome, Crohn's disease etc; 3. Use of oral corticosteroids within the past 4 weeks; 4. Presence of upper or lower respiratory tract infection or treatment with antibiotics within the previous 4 weeks; 5. Pregnancy as determined by menstrual history or urine pregnancy test; 6. Current smokers will be excluded. Anyone with a smoking history > 0.5 pack year and/or >1 pack per month will also be excluded. 7. History of bleeding disorder; 8. Recent nasal surgery (with 6 months). If a subject has had nasal surgery between 6 months and 5 years, a study physician will visualize the area prior to the biopsy to evaluate the suitability of the nose for the procedure. 9. History of intolerance of or aversion to broccoli 10. Unable to withhold nasal steroids for 2 weeks before each session. These subjects may be deferred until after their allergy season
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-60.0, Asthma Healthy males and females aged 18-60 years Normal weight, at least 50 kg Evidence of clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study Known hypersensitivity to the active substance(s) or the excipient of the drug Pregnant or lactating females
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 12.0-999.0, Muscle Tightness healthy feet and ankles must have limited dorsiflexion ROM. Limited dorsiflexion will be judged by patient having <12 degrees of DF PROM with knee extended, or <50 degrees of weight bearing DF ROM with the knee flexed inability to fully weight bear through their lower extremities have <0-90 degrees of ROM in their knees inability to follow directions presence of a Lower Extremity fracture pregnant or nursing
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-64.0, Atopic Asthma Age 18 to 64 years (inclusive). 2. Male or female. 3. If male, is surgically sterile (vasectomy) or agrees to comply with required contraceptive measures. 4. If female, not pregnant (or lactating), as evidenced by a negative serum pregnancy test, and is either surgically sterile (hysterectomy, bilateral ovariectomy, or bilateral tubal ligation), or if a female of childbearing potential, agrees to comply with required contraceptive measures. 5. History of episodic wheeze and shortness of breath with a prebronchodilator FEV1 ≥70% of predicted at screening. 6. Asthma symptoms treated (if necessary) only with intermittent short-acting ß-agonist therapy by inhalation. 7. Demonstration of a positive wheal reaction on skin prick testing to at least 1 common aeroallergen at screening. 8. Screening inhalational allergen challenge response demonstrating that the subject experiences both an early asthmatic response (EAR) and a late asthmatic response (LAR). 9. Methacholine PC20 ≤16 mg/mL at screening. 10. No history of smoking within 6 months of screening, and with a total pack year history of ≤10 pack years. 11. 12-lead ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the investigator. 12. All values for hematology, clinical chemistry, and urinalysis within the normal range, or if abnormal, are deemed not clinically significant by the investigator with documented agreement from the medical monitor. 13. Is able to give written informed consent Past or present disease which, as judged by the investigator, may affect the outcome of this study. 2. Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the screening period. 3. Symptomatic allergic rhinitis. Those subjects with a history of allergic rhinitis may participate if asymptomatic at screening (and continue to be so at baseline on Day 1 prior to dosing) and if, in the opinion of the investigator, it is unlikely that disease exacerbation will occur during the course of the study. 4. History of life-threatening asthma. 5. Abnormal chest X-ray. 6. Use of oral, injectable, or dermal steroids within 3 months and/or inhaled steroids within 1 month of screening. 7. Use of cromoglycate, nedocromil, leukotriene receptor antagonists (zafirlukast, pranlukast, montelukast), and inhibitors of 5-lipoxygenase (zileuton) within 4 weeks of screening. 8. Use of immunosuppressives, anticoagulants (warfarin or heparin), or any medications that may interact with pharmacodynamic (PD) effects of AXP1275 within 4 weeks of screening. 9. Use of theophylline-containing agents (any type) and long-acting β2-agonists (salmeterol, formoterol) within 4 weeks of screening. 10. Positive screen for drug(s) of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, or benzodiazepines) or cotinine. 11. Positive for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus (HIV) 1/2. 12. Has participated in a clinical trial and has received an investigational product within 30 days prior to screening, or 5 elimination half lives of the investigational product, whichever is longer. 13. Has had significant blood loss (>500 mL) or donation of blood within 2 months prior to screening visit 1. 14. History of being unable to tolerate or complete methacholine or allergen challenge tests. 15. Subject is undergoing allergen desensitization therapy. 16. History of immunotherapy in the 3 years prior to screening or concurrently undergoing immunotherapy treatment. 17. Professional or ancillary personnel involved in the study. 18. Is not, in the opinion of the investigator, suitable for entry into the study
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 45.0-999.0, Chest Pain Coronary Artery Disease Angina All patients who meet and enroll in the parent study will be eligible to participate in 1. New or worsening chest pain syndrome or equivalent symptoms suspicious for clinically significant coronary artery disease 2. No prior evaluation for this episode of symptoms 3. Planned non-invasive testing for evaluation of possible coronary artery disease 4. Men age > 55 and women age ≥65 years 5. If age in men 45 or women 50 years, then must have increased probability of CAD due to A. Diabetes Mellitus (DM) requiring medical treatment OR Peripheral Arterial Disease (PAD) defined as documented >50% peripheral arterial stenosis treated medically or invasively OR Cerebrovascular disease (stroke, documented > 50% carotid stenosis treated medically or invasively) OR B. At least one of the following cardiovascular risk factors Ongoing tobacco use Hypertension Abnormal ankle-brachial index defined as less than <0.9 Dyslipidemia 6. Serum creatinine < 1.5 mg/dL within the past 90 days 7. Negative urine/serum pregnancy test for female subjects of child-bearing potential and not breast-feeding Diagnosed or suspected acute coronary syndrome requiring hospitalization or urgent or emergent testing; Elevated troponin or creatinine kinase-MB 2. Hemodynamically or clinically unstable condition (systolic blood pressure < 90 mmHg, atrial or ventricular arrhythmias, or persistent resting chest pain felt to be ischemic despite adequate therapy) 3. Known coronary artery disease with prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting or any angiographic evidence of coronary artery disease ≥50% lesion in a major epicardial vessel. 4. Any invasive coronary angiography or non-invasive anatomic or functional cardiovascular test for detection of coronary artery disease, including coronary computed tomographic angiography and exercise electrocardiogram, within the previous twelve (12) months. 5. Known significant congenital, valvular (> moderate) or cardiomyopathic process (hypertrophic cardiomyopathy or reduced systolic left ventricular function (left ventricular ejection fraction ≤ 40%)) which could explain cardiac symptoms. 6. Contraindication to undergoing a coronary computed tomographic angiography, including but not limited to: a. Pregnancy or breastfeeding 7. Life expectancy < 2 years 8. Unable to provide written informed consent or participate in long-term follow-up
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 4.0-11.0, Asthma parent/legal guardian and subject must be able to speak and understand English and patient must be willing and able to give assent to take part in the study diagnosed with asthma for at least 6 months able to demonstrate inhalation technique with study device if taking inhaled corticosteroids, dose must be stable for 2 weeks no significant concomitant medical conditions or abnormal physical findings on screening except for those consistent with asthma and allergic rhinitis airway responsiveness to methacholine with a baseline provocational dose causing an increase of at least 40% in R5 (PC40R5) at no more than 8 mg/mL female who has started menstruating past or present history of any allergic reaction to any of the medications or formulations administered in this study prior treatment with systemic corticosteroids in last 30 days or more than 4 courses in previous 12 months use of short-acting beta-agonist more than two times per week in the previous month use of long-acting beta-agonist in the 3 weeks before the first methacholine challenge or during the study change in dosage of inhaled corticosteroids in previous 30 days, nasal steroids in previous 15 days and montelukast in last 7 days history of life-threatening asthma, including loss of consciousness, intubation and/or admission to ICU hospitalization for acute asthma within past year inability to withhold the following medications before methacholine challenges short-acting beta-agonists at least 6 hours
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-999.0, Chronic Obstructive Pulmonary Disease chronic obstructive pulmonary disease acute respiratory failure under ventilator support for less than 72 hours endotracheal tube inserted confirmed asthma Acute Physiology and Chronic Health Evaluation II score over 35 a co-morbidity of septic shock
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-999.0, Allergic Rhinitis be at least 18 years of age positive ST to Dust Mite history of allergic rhinitis no active infections no disallowed medications no nasal anatomical deformities or nasal surgical interventions in the past
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-999.0, Asthma Asthma for at least 6 months, using inhaled corticosteroid for at least one month, foreced breath test less than below the normal value of the general population, -show an immediate improvement in breathing when given albuterol patients who have smoked in the past 6 months or are currently smoking, including those who smoked more than a pack of cigarettes a day for at least 10 years, -patients who have a history of life-threatening asthma, -patients who have had an astham attack, in the last 6 weeks, requiring use of systemic steroids, hospitalization, or ER visit, -patients who have had a respiratory tract infection or worsening asthma between screening or run-in periods, patients requring use of other asthma-related drugs during the trial, other protocol-defined inclusion/exclusion may apply
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-999.0, Asthma Criteria:70 adult (over 18 years) subjects with the following features doctor's diagnosis of asthma and right to special reimbursement from anti-asthma medication expenses according to Finnish Social Insurance Institute (code 203 in the social insurance card) asthma diagnosis confirmed at least two years previously regular treatment with inhaled corticosteroids and long-acting beta-agonists for at least 6 months no changes in regular anti-asthma medication within 6 months asthma is well controlled (all conditions must be fulfilled) No courses of oral corticosteroids due to asthma within one year No hospital admissions due to asthma within one year Juniper's Asthma Control Questionnaire score equal or less than 0.75 the presence of another chronic respiratory disease in addition to asthma. Such diseases moderate to severe polypotic chronic rhinosinusitis, chronic obstructive pulmonary disease, sarcoidosis, and cystic fibrosis presence of severe co-morbidity history of smoking more than 10 pack-years pregnancy
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 5.0-999.0, Asthma Individuals who self-report Black ancestry (with at least 1 Black grandparent). 2. Able to perform reproducible spirometry according to ATS criteria. 3. Clinical history consistent with asthma. 4. Baseline FEV1≥40% of predicted and/or post-bronchodilator FEV1≥40% of predicted. 5. Asthma confirmed either by: (1) Beta-agonist reversibility to 4 puffs albuterol ≥ 12% OR (2) PC20FEV1 ≤ 16 mg/ml OR (3) an absolute relative change in %predicted FEV1 of ≥ 12% over two measurements documented by repeat spirogram over the previous year 6. Either: A) inadequately controlled on low-, medium or high-dose ICS monotherapy, or low or medium-dose ICS/LABA, or B) well-controlled on medium or high-dose ICS monotherapy, or low-, medium or high-dose ICS/LABA. Inadequate asthma control will be defined as an ACT/c-ACT score <20; well-controlled asthma will be defined as an ACT/c-ACT score ≥20. 7. Stable asthma controller therapy dose (ICS or ICS/LABA) for the 2 weeks prior to enrollment. 8. Non-smoker (total lifetime smoking history < 5 pack-years if <18, or <10 pack-years if ≥18 years of age; no smoking for at least 1 year). 9. For participants ≥18 years of age: Ability to provide informed consent. For participants under 18 years of age: Ability to provide verbal or written assent and ability of parent to provide informed consent Medical contraindication to LABA or history of adverse reactions to ICS or LABA preparations or any of their ingredients. 2. Current or prior use of medications known to significantly interact with corticosteroid disposition within the two-week period preceding enrollment. 3. Unwilling to provide a blood sample for DNA extraction and genetic analysis. 4. Major medical problems prohibiting study participation, i.e. presence of chronic or active lung disease other than asthma or history of unstable significant medical illness other than asthma, including thyroid disease, diabetes mellitus, Cushing's disease, Addison's disease, hepatic disease, or concurrent medical problems that could require oral corticosteroids during the study or that would place the participant at increased risk. 5. Systemic corticosteroid treatment for any condition within 4 weeks of enrollment or more than five courses of systemic corticosteroids in the past year. 6. History of a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure within the last 2 years. 7. History of a respiratory tract infection within 4 weeks of enrollment. 8. If a female of child-bearing potential, failure to practice abstinence or use an acceptable birth control method. 9. Pregnancy or lactation or planning to get pregnant during the course of the trial. 10. Receiving hyposensitization therapy other than an established maintenance regimen defined as a continuous regimen for ≥ 3 months prior to enrollment. 11. Participation in an intervention trial or use of investigative drugs in the past 30 days or plans to enroll in such a trial during the study
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 12.0-80.0, Asthma Male or female >=12 and <=80 years of age at the time of signing the informed consent A female subject is eligible to participate if she is of Non-childbearing potential defined as premenopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone >40 milli international unit per milliliter (mIU/mL) and oestradiol <40 picogram (pg)/mL [<147 picomole per liter (pmol/L)] is confirmatory); Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods (i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study from Screening to follow-up contact) if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrolment. For most forms of HRT, at least 2 to 4 weeks should elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. After confirmation of their postmenopausal status, they can resume use of HRT during the study without use of a contraceptive method; child-bearing potential and is abstinent or agrees to use one of the contraception methods for an appropriate period of time (as determined by the product label or investigator) before the start of dosing to sufficiently minimise the risk of pregnancy at that point. Female subjects must agree to use contraception until at least 2 days post the last dose of study treatment; abstinence from penile-vaginal intercourse must be consistent with the preferred and usual lifestyle of the subject Severity of disease: A best prebronchodilator FEV1 of >=40% to <=85% of the predicted normal value at Visit 1 (Screening and Run-in Visit). Predicted values will be based upon National Health and Nutrition Examination Survey (NHANES) III. If a subject is recorded as having Hispanic or Latino ethnicity, then the Mexican-American equations will be used (irrespective of race). If a subject is recorded as being of African-American/African heritage race, then the African American equations will be used. If a subject is recorded as being of Asian race, then the Asian adjustment will be used. Otherwise, the Caucasian equations will be used Reversibility of disease: Demonstrated >=12% and >=200 mL reversibility of FEV1 within 10 to 40 minutes after 2 to 4 inhalations of salbutamol inhalation aerosol (or equivalent nebulised treatment with salbutamol solution) at Visit 1 (Screening and Run-in Visit) Current anti-asthma therapy: All subjects must be using an Inhaled Corticosteroid (ICS) with or without long-acting beta-adrenergic agonist (LABA) for at least 8 weeks and a stable dose for at least 4 weeks before Visit 1 (Screening and Run-in Visit). Two populations are eligible for enrolment Subjects maintained on ICS monotherapy (FP 100 mcg to 250 mcg BID or equivalent) for at least 8 weeks and a stable dose for at least 4 weeks before Visit 1 (Screening and Run-in Visit) or Subjects maintained on an ICS/LABA combination product (e.g., Fluticasone propionate/salmeterol 100/50 or 250/50 mcg BID or equivalent by other combination products or by separate inhalers) for at least 8 weeks and a stable dose for at least 4 weeks before Visit 1 (Screening and Run-in Visit). Subjects taking budesonide/formoterol or beclomethasone/formoterol as needed must switch to budesonide/formoterol maintenance dosing (excluding the highest dose) with use of a SABA for symptom relief at least 8 weeks and a stable dose for at least 4 weeks before Visit 1 (Screening and Run-in Visit). NOTE: Subjects on low dose ICS monotherapy should only be enrolled, if, in the opinion of the investigator, after review of their medical history and clinical examination, they will be able to benefit from both an increase in ICS dose and the addition of LABA therapy arising from and ICS/LABA combination Ability to withhold LABA therapy: Other than what is provided during the study, LABA therapy is not permitted on the day of Visit 1 (Screening and Run-in Visit) and throughout the entire study. The last dose of LABA and LABA/ICS combinations are to be taken on the day before Visit 1. Sites should contact the medical monitor to discuss subject for doses of commonly prescribed ICS and ICS/LABA combination medication; as mentioned in the study protocol SABA: All subjects must be able to replace their current SABA treatment with rescue salbutamol/albuterol at Visit 1 (Screening and Run-in Visit) for use as needed for the duration of the study. Subjects must be able to withhold salbutamol/albuterol for at least 6 hours before each study visit Liver safety Alanine aminotransferase (ALT) <=2 the upper limit of normal (ULN), Alkaline phosphatase and bilirubin <=1.5 ULN (isolated bilirubin >1.5 ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%) at Visit 1 (Screening and Run-in Visit) History of life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures within the last 10 years Respiratory infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1 (Screening and Run-in Visit) and led to a change in asthma management, or in the opinion of the investigator, is expected to affect the subject's asthma status or ability to participate in the study Asthma exacerbation: Any asthma exacerbation requiring oral corticosteroids within 12 weeks of Visit 1 (Screening and Run-in Visit) or that resulted in overnight hospitalisation requiring additional treatment for asthma within 6 months before Visit 1 (Screening and Run-in Visit) Concurrent respiratory disease: A subject must not have current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities other than asthma Other concurrent diseases/abnormalities: A subject must not have any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study. Additional excluded conditions/diseases are included in the study protocol Evidence of a severe exacerbation, defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalisation or emergency department visit due to asthma that required systemic corticosteroids between Visit 1 (Screening and Run-in Visit) and Visit 2 (randomisation and Treatment Period 1 Baseline Visit) Oropharyngeal examination: A subject will not be eligible for the Run-in if he/she has clinical visual evidence of candidiasis at Visit 1 (Screening and Run-in Visit) Investigational medications: A subject must not have administered any investigational drug within 30 days before Visit 1(Screening and Run-in Visit) or within five half-lives of the prior investigational drug (whichever is the longer of the two). The prior investigational drug half-life may be confirmed with the prior investigational study sponsor or by consulting relevant study documentation Allergies: Drug allergy; Any adverse reaction including immediate or delayed hypersensitivity to any beta2 agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the FSC multi-dose inhaler and capsule-based inhaler (i.e., lactose), Milk protein allergy; History of severe milk protein allergy Concomitant medications: Administration of prescription or over the counter medication that would significantly affect the course of asthma, or interact with study treatment, such as: anticonvulsants (barbiturates, hydantoins, carbamazepine); polycyclic antidepressants; beta-adrenergic blocking agents; phenothiazines; and monoamine oxidase (MAO) inhibitors
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 40.0-80.0, Pulmonary Disease, Chronic Obstructive Male or female >=40 and <=80 years of age at the time of signing the informed consent A female subject is eligible to participate if she is of: Non-childbearing potential defined as premenopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone >40 milli international unit per milliliter (mIU/mL) and oestradiol <40 picogram [pg]/mL [<147 picomole per liter (pmol/L)] is confirmatory); females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods (i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study from Screening to follow-up contact) if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrolment. For most forms of HRT, at least 2 to 4 weeks should elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. After confirmation of their postmenopausal status, they can resume use of HRT during the study without use of a contraceptive method; child-bearing potential and is abstinent or agrees to use one of the contraception methods for an appropriate period of time (as determined by the product label or investigator) before the start of dosing to sufficiently minimise the risk of pregnancy at that point. Female subjects must agree to use contraception until at least 2 days post the last dose of study treatment; abstinence from penile-vaginal intercourse must be consistent with the preferred and usual lifestyle of the subject COPD Diagnosis: An established clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society Severity of Disease: A measured pre and post-salbutamol/albuterol FEV1/forced vital capacity (FVC) ratio of <0.70 at Visit 1 (Screening and Run-in Visit) A measured pre-salbutamol/albuterol FEV1 <50% of predicted normal values at Visit 1 (Screening and Run-in Visit). A measured post-salbutamol/albuterol FEV1 >=30% of predicted normal values at Visit 1 (Screening and Run-in Visit). Predicted values will be calculated using the National Health and Nutrition Examination Survey (NHANES) III reference equations Tobacco Use: Current or prior history of at least 10 pack-years of cigarette smoking (e.g., 20 cigarettes/day for 10 years). One pack-year is defined as 20 manufactured cigarettes (1 pack) smoked per day for 1 year. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1 (Screening and Run-in Visit). Former smokers are eligible to enter the study provided they have at least 10 pack-years smoking history. Subjects making a conscious decision to stop smoking at any time during the study and who refrain from smoking for >4 weeks will be discontinued from the study. Additionally, subjects who start smoking during the study and smoke for at least 7 consecutive days will be discontinued from the study Dyspnoea: A score of >=2 on the Modified Medical Research Council Dyspnoea Scale (mMRC) at Visit 1 (Screening and Run-in Visit) Liver Safety Alanine aminotransferase (ALT) <=2 the upper limit of normal (ULN), alkaline phosphatase and bilirubin <=1.5 ULN (isolated bilirubin >1.5 ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%) at Visit 1 (Screening and Run-in Visit) Electrocardiogram (ECG) Safety The subject must have no ECG abnormalities that would, in the opinion of investigator, compromise subject safety, or significantly affect subject's ability to complete the trial. As such the investigator will determine the clinical significance of any ECG abnormality and determine if a subject is precluded from entering the study. At Visit 1 (Screening and Run-in Visit), ECG safety must be: QT interval corrected for heart rate (QTc) or QT interval corrected for heart rate according to Fridericia formula (QTcF) <450 milliseconds (msec) or QTc <480 msec for subjects with a bundle branch block. Investigators will be responsible for ensuring appropriate clinical interpretation of ECGs Able to use the inhaler devices adequately after training A current diagnosis of asthma Any clinically significant and uncontrolled disease, including but not limited to the following: neurological, psychiatric, renal, immunological, endocrine/metabolic (including uncontrolled diabetes, hypokalaemia or thyroid disease), cardiovascular, neuromuscular, hepatic, gastric, or haematological abnormalities, or peripheral vascular disease. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk or would affect the efficacy analysis if the disease/condition exacerbated during the study A respiratory diagnosis other than COPD (e.g., lung cancer, bronchiectasis, sarcoidosis, tuberculosis, lung fibrosis), including subjects with a diagnosis of alpha-1-antitrypsin deficiency. Allergic rhinitis is not exclusionary An abnormal and clinically significant chest X-ray film or computed tomography scan not believed to be a result of the presence of COPD. A chest X-ray must be taken if the subject has not had 1 within 6 months of Visit 1 (Screening and Run in Visit) Lung resection surgery (e.g., lung volume reduction surgery, or lobectomy) within 1 year of Visit 1 (Screening and Run-in Visit) A COPD exacerbation and/or infection of the upper or lower respiratory tract requiring treatment with systemic (oral or parenteral) corticosteroids and/or antibiotics that has not resolved within 30 days of Visit 1 (Screening and Run-in Visit) A COPD exacerbation that resulted in hospitalisation that has not resolved within 3 months of Visit 1 (Screening and Run-in Visit) Use of nocturnal-positive pressure (e.g., continuous positive airway pressure or bilevel positive airway pressure) Oropharyngeal Examination: A subject will not be eligible for the Run-in Period if he/she has clinical visual evidence of candidiasis at Visit 1 (Screening and Run-in Visit) An abnormal and clinically significant 12-lead ECG result. For the purposes of this study, an abnormal ECG result is defined as a 12-lead tracing that is interpreted as demonstrating (but not limited to) any of the following: Myocardial ischemia, clinically significant conduction abnormalities (e.g., left bundle branch block, Wolff-Parkinson-White syndrome), clinically significant arrhythmias (e.g., atrial fibrillation, ventricular tachycardia). The study investigator will determine the clinical significance of any ECG abnormality and determine if a subject is precluded from entering the study
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 40.0-65.0, Adult Lymphoblastic Lymphoma Disease ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration Philadelphia chromosome positive ALL is allowed Lymphoid blastic crisis of CML will be included (provided that patients achieve CR) Age Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen Organ Function All organ function testing should be done within 28 days of study registration Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL) Hepatic Non-compliant to medications No appropriate caregivers identified HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive Active life-threatening cancer requiring treatment other than ALL Uncontrolled medical or psychiatric disorders Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration Active central nervous system (CNS) leukemia Preceding allogeneic HSCT Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-999.0, Breast Cancer Nos Metastatic Recurrent Women Aged 18 years and over With an invasive breast cancer diagnosed by cytology or histology Tumors cT0 to cT3, CN0-3 No clinical evidence of metastasis at the time of Untreated including scored for breast cancer surgery in progress Patient receiving a social security system Patient mastering the French language Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage Metastatic breast cancer Local recurrence of breast cancer History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix Already received treatment for breast cancer ongoing Blood transfusion performed for less than six months Persons deprived of liberty or under supervision (including guardianship)
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-999.0, Thyroid Cancer Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary type; TNM classification system) Willing to participate in the EG meetings >18 years Alert and capable of giving free and informed consent Able to speak and read English or French Anaplastic thyroid cancer Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC) or referring physician) or expected survival <6 months according to clinical judgment
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-65.0, Chronic Pain Women Clinical diagnosis of chronic pelvic pain More than eighteen years Non-menstrual or noncyclic pelvic pain Duration of pain of at least 6 months Duration of pain less than 6 months Women who were pregnant in the last 12 months
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-999.0, Coronary Artery Stenosis Age ≥ 18 years Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked Non-target vessel PCI are allowed prior to randomization depending on the time interval and conditions as follows: a. During Baseline Procedure: i. PCI of non-target vessels performed during the baseline procedure itself immediately prior to randomization if successful and uncomplicated defined as: <50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding. b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see #3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as defined above. ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling. d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. Angiographic (visual estimate) Treatment of up to three de novo target lesions, maximum of one de novo target lesion per vessel Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to <100% Lesion must be ≤28 mm long and can be covered by a single study stent with maximum length of 33 mm (note: multiple focal stenoses may be considered as a single lesion and be enrolled if they can be completely covered with one stent) TIMI flow 2 or 3 If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria Planned procedures after the baseline procedure in either the target or non-target vessels STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin)have not peaked PCI within the 24 hours preceding the baseline procedure and randomization Non-target lesion PCI in the target vessel within 12 months of the baseline procedure History of stent thrombosis Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP Known LVEF <30% Subject is intubated Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment) Hemoglobin <10 g/dL
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 3.0-14.0, Influenza Children in schools randomized to LAIV cannot receive this vaccine if they have any of the following contraindications: severe asthma (defined as currently on oral or high-dose inhaled glucocorticosteriods or active wheezing) or medically attended wheezing in the 7 days prior to vaccination; receiving aspirin or aspirin-containing therapy because of the association of Reye's syndrome with aspirin and wild-type influenza infection; or immune-compromising conditions due to underlying disease and/or therapy, as the vaccine contains live attenuated virus. These children will receive TIV instead, unless they have a contraindication to receiving TIV. Children in schools assigned to TIV cannot receive this vaccine if they have any of the following contraindications: an anaphylactic reaction to a previous dose; an anaphylactic reaction to any of the vaccine components, with the exception of egg; or Guillain-Barré Syndrome (GBS) within six weeks of a previous influenza vaccination
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 19.0-85.0, Asthma Mixed Asthma With Acute Exacerbation Physician diagnosed asthma. 2. A history of an asthma exacerbation requiring oral corticosteroids or admission to Emergency Department/hospital in the previous year. 3. Ability to understand English and follow the material included in the two different interventions. 4. Ownership of a mobile phone with the capacity to support text messaging. 5. Patients on maintenance inhaled corticosteroids alone or with a combination inhaler. Subjects on other controller therapies will not be excluded as long as they fulfill these criteria. - Inability to provide written informed consent. 2. A history of smoking cigarettes for greater than ten pack years. 3. Not owning a mobile cell phone. 4. Subjects only taking a reliever medication and on no controller medication. 5. A history of significant co morbid disease judged by the investigator to preclude enrolment. 6. A history of an asthma exacerbation requiring oral corticosteroids in the previous six weeks. 7. Plans to move out of the study area in the next year. -
|
2
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-80.0, Asthma Adults with persistent asthma (defined as per the Global INitiative for Asthma Management (GINA) criteria) If they had a respiratory tract infection or asthma exacerbation within 30 days prior to If they were receiving oral steroids or immunosuppressive treatments
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 16.0-999.0, Asthma Male or female volunteers aged at least 16 years with persistent asthma and on inhaled corticosteroids (at least 400 micrograms of beclomethasone dipropionate or the equivalent FEV1 > 50 % predicted Mannitol PD15 < 635 mg Ability to give informed consent Agreement for their general practitioner to be made aware of study participation and to receive feedback as relevant to the participant's well being Other respiratory diseases such as chronic obstructive pulmonary disease, bronchiectasis or allergic bronchopulmonary aspergillosis An asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 3 months of the study commencement Any clinically significant medical condition that may endanger the health or safety of the participant Smoking within one year or >10 pack year history Participation in another trial within 30 days before the commencement of the study Pregnancy or lactation Unable to comply with the procedures of the protocol
|
2
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 16.0-85.0, Cough Patients will be required to demonstrate significant cough symptoms by a score greater than 20/70 on the Hull Airways Reflux Questionnaire All patients must be current non-smokers Patients must be on stable medication for at least one month Patients must be able to attend the trials unit on at least 3 occasions Patients must have normal lung function patients must be able to give informed consent Subjects who are pregnant, or have pacemakers in situ are excluded from this study Those with a serious comorbid conditions such as cancer, severe COPD, or heart failure will be excluded Those who are non-English speakers and special groups (i.e. mentally ill, children under 16 years of age, and those suffering from dementia) will be excluded No test will be performed on any subject during an acute worsening of asthma or upper airway infection. If the subject has had an upper airway infection in the last three weeks they will be offered another appointment If the subject has taken any over the counter (OTC) cough mixture within the last twelve hours: If the subject is willing to come back another time for challenge testing, another appointment should be made If the subject has had any food or drink products containing caffeine or menthol within the last hour. If the subject is unwilling to wait for 1 hour before starting the test, the subject should return another time. If the subject is unwilling to return another time, testing should proceed and the medication used recorded If the participant is currently involved in research, or within 3 months of participation in any type of research, they will be excluded from this study
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 4.0-11.0, Asthma Written informed consent Asthma diagnosis: The patient has a diagnosis of asthma as defined by the National Institute of Health (NIH). The asthma diagnosis has been present for a minimum of 3 months and has been stable (defined as no exacerbations and no changes in medication) for at least 30 days before screening visit Severity of disease: The patient has persistent asthma, with a forced expiratory volume in 1 second (FEV1) 40% to 90% of the value predicted for age, height, and sex at screening visit (SV) Current asthma therapy: The patient is currently being treated with 1 of the following: 1) a stable daily dosage of an inhaled corticosteroid (ICS) in the range of 88-176 mcg/day of fluticasone propionate (or equivalent) for a minimum of 4 weeks (28 days) before screening visit 2) a stable daily dosage of non-corticosteroid therapy 3) a daily dose of ICS plus a long-acting beta2-agonist (LABA) (at a dose less than or equivalent to fluticasone propionate 100 mcg/salmeterol 50 mcg twice daily) Reversibility of disease: The patient has demonstrated at least 12% reversibility of FEV1 within 30 minutes after 2-4 inhalations of albuterol/salbutamol hydrofluoroalkane (HFA) MDI (90 mcg ex-actuator) or equivalent at screening visit or on retesting Other apply, please contact the investigator for more information The patient has a history of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures The patient is pregnant or lactating, or plans to become pregnant during the study period or for 30 days after the patient's last study-related visit (for eligible patients only, if applicable). Any patient becoming pregnant during the study will be withdrawn from the study The patient has a known hypersensitivity to any corticosteroid or any of the excipients in the study drug or rescue medication formulation The patient has used tobacco products within the past year (eg, cigarettes, cigars, chewing tobacco, or pipe tobacco, as applicable) The patient has had an asthma exacerbation requiring oral corticosteroids within 30 days before screening visit, or has had any hospitalization for asthma within 2 months before screening visit The patient has historical or current evidence of a clinically significant disease. Significant disease is defined as any disease that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study Other apply, please contact the investigator for more information
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 12.0-999.0, Persistent Asthma Severity of Disease: The patient has persistent asthma, with an forced expiratory volume in 1 second (FEV1) 40%-85% of the value predicted for age, height, sex, and race as per the National Health and Nutrition Examination Survey (NHANES III) reference values at screening visit (SV) (Hankinson et al 1999) Current asthma therapy: The patient is currently being treated with 1 of the following: 1) inhaled corticosteroids (ICSs) at a stable daily dose of less than or equal to 220 mcg/day fluticasone propionate via metered dose inhaler (MDI) or equivalent for a minimum of 4 weeks (28 days) before screening visit, or 2) a stable daily dosage of non-corticosteroid therapy, including leukotriene modifiers, theophylline, chromones, or short-acting beta-2 agonists (SABAs) alone or in combination for a minimum of 4 weeks (28 days) before screening visit (SV) Reversibility of disease: The patient has demonstrated at least 15% and at least 200 mL increase from baseline FEV1 (patients age 18 and older) within 30 minutes after 2-4 inhalations of albuterol/salbutamol hydrofluoroalkane (HFA) MDI (90 mcg ex-actuator) or equivalent at SV or on retesting Other apply, please contact the investigator for more information The patient has a history of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest, or hypoxic seizures The patient is a pregnant or lactating female or plans to become pregnant The patient has a known hypersensitivity to any corticosteroid or any of the excipients in the study drug or rescue medication formulation The patient currently smokes or has a smoking history of 10 pack-years or more (a pack-year is defined as smoking 1 pack of cigarettes/day for 1 year). The patient may not have used tobacco products within the past year The patient has had an asthma exacerbation requiring oral corticosteroids within 1 month before SV, or has had any hospitalization for asthma within 2 months before SV The patient has historical or current evidence of a clinically significant disease. Significant disease is defined as any disease that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study Other apply, please contact the investigator for more information
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 8.0-999.0, Diet Modification Chronic Urticaria Urticaria +/ angioedema present for a minimum of 6 weeks Agree to be on anti-histamine prn Age older than 8 years old, with no upper age limit Causes such as parasite infestation, microbial and viral infections, autoimmune disease, or other pathology that could account for the U/A/P should be excluded Skin prick test and/or radioallergosorbent (RAST) test are negative for all food allergens tested, or patient had achieved no symptomatic improvement after strict avoidance of all skin test-positive foods Pregnant or breast feeding women Patients who is taking central nervous system (CNS) acting agents (including tranquilizers, antidepressants, sedatives, hypnotics or antiepileptics) at any time
|
0
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-45.0, Asthma Age ranging between 18 and 45 years Diagnosis of asthma No exacerbations during last month History of spine surgery Diabetes, neurological or a cardiovascular disease Spine deformities and use of orthopedic devices
|
1
|
A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
|
eligible ages (years): 18.0-999.0, Dyspnea All patients requiring dispatch of emergency physician because of severe dyspnea. Severe dyspnea is defined by dyspnea plus at least ONE of the following Respiration frequency > 20 or < 8 Saturation < 96 without supplementary oxygen Heart rate > 100 or < 50 Systolic blood pressure < 100 or > 200 Difficulty talking Central or peripheral cyanosis Use of accessory muscles of respiration Glasgow coma scale score < 15 AND because of the physical condition, the patient is not able to give informed consent Age < 18
|
0
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.