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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.
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eligible ages (years): 18.0-999.0, Heart Failure, Congestive Hospitalized for heart failure in the 6 months prior to study entry Able to read and write English Lives independently Current participation in a heart failure management program Impaired cognition Serious co-morbidity
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0
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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.
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eligible ages (years): 18.0-80.0, Asthma Generally healthy men and women with persistent asthma, 18 to 70 years of age, with body weight between 50 kg and 115 kg History of treatment with a medium to high dose of inhaled corticosteroids (ICS), with or without long-acting beta-agonists (LABA), for at least 2 months prior to the screening visit and must remain constant during the study FEV1 ≥ 55% to ≤ 80% predicted and demonstrated improvement in FEV1 (L) with inhaled albuterol (salbutamol) (reversibility) of ≥ 12%
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2
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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.
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eligible ages (years): 12.0-999.0, Asthma Subjects must be 12 years of age or older of either gender, who (and their parent/guardian if the subject is under the age of 20) must demonstrate their willingness to sign and write informed consent Subjects must have had a history of asthma for at least 6 months The subject must be diagnosed mild persistent or moderate persistent asthma and his/her FEV1 must be >= 60% of predicted normal at both the Screening and Baseline visits, when short-acting inhaled beta agonists have been withheld for at least six hours and long-acting inhaled beta agonists have been withheld for at least 12 hours Subjects must demonstrate an increase in absolute FEV1 of >= 12%, with an absolute volume increase of at least 200 mL, after reversibility testing at the Screening visit, or historically within the past 12 months; Subjects without documented absolute FEV1 of >= 12% in reversibility test within the past 12 months need to demonstrate a positive result in Methacholine challenge test If Subjects with ICS treatment have been using ICS on a daily basis for at least 4 weeks prior to Screening. For the two weeks prior to Screening, subjects must have been on a stable regimen of ICS. Each ICS dose is shown in following Flunisolide between 1000 to 2000 mcg/day Budesonide between 400 to 800 mcg/day Triamcinolone acetonide between 600 to 1600 mcg/day Beclomethasone Dipropionate between 252 to 840 mcg/day Fluticasone propionate between 200 to 500 mcg/day Female subjects who are pregnant, breast-feeding, or are pre-menarcheal Subjects who are heavy smokers (more than 10 pack years) or who smoked within previous 6 months Subjects who have required daily or alternate day oral corticosteroid treatment for more than a total of 14 days during the 3 months immediately prior to the Screening visit, and/or subjects who have required a course of systemic corticosteroids within the previous month Subjects who used Leukotriene modifiers within 2 weeks of screening Subjects who took immunosuppressive agents within the previous 3 months Subjects who use daily nebulized ß2-adrenergic agonists Subjects who have had either an asthma exacerbation or a clinically relevant change in asthma medication within the last 4 weeks Subjects who have been admitted to the hospital for asthma control within the previous 3 months or have needed emergency service for asthma more than once within the previous 6 months Subjects who have required ventilator support for respiratory failure secondary to their asthma within the last 5 years Subjects who have used any investigational drug in the 30 days prior to Baseline, or subjects who have been treated with any investigational antibody for asthma in the 90 days prior to Baseline
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1
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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.
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eligible ages (years): 18.0-75.0, Asthma Sign informed consent Be 18-75 years of age, of either sex and any race Have asthma for >= 12 months Have mild or moderate persistent asthma Prior to completing Screening Visit procedures, must be using: low or moderate doses of an inhaled corticosteroid (IC), with a short-acting beta-2 agonist (SABA) as needed (prn) or a SABA prn as monotherapy. Those using a combination ICs plus long-acting beta-2 agonist (LABA) medication, such as Advair 100/50 twice daily (BID), must be changed to fluticasone propionate 100 mcg BID for at least 5 days prior to the start of Run-In-Period. Those using LABA as monotherapy must be switched to SABA prn for at least 5 days prior to the start of Run-In Period Be off treatment with leukotriene receptor antagonist (LTRA) for at least 14 days prior to Screening Have an FEV1 >=65% but <=85% of predicted normal value at Screening and at Baseline when SABAs have been withheld for at least 6 hours Demonstrate an increase of absolute FEV1 of >= 12% with an absolute volume increase of at least 200mL during Screening. Written documentation of FEV1 reversibility of >= 12% within 2 years prior to Screening was acceptable in lieu of testing. FEV1 reversibility testing should be done after withholding inhaled SABA for at least 6 hours Have a frequency of asthma score of at least 2 (at least 2 symptoms) and/or frequency of bronchodilator use score of at least 2 at Screening Have a Total Asthma Severity Score (TASS) of at least 4 on 8 or more of the AM and PM recordings from the last 7 days during the Run-in period prior to Baseline and the AM of the Baseline Visit Women who are pregnant or intend to become pregnant during the study Women who are nursing or intend to nurse during the study or within 30 days after completion Have participated in any clinical trial within the last 30 days or in one involving antibodies for asthma or rhinitis within 3 months prior to Screening Have had an unscheduled medical visit (due to exacerbation of asthma) within 1 month prior to Screening Have been treated in the emergency room or admitted to the hospital due to exacerbation of asthma on two or more occasions within the 12 months prior to Screening Have used >12 puffs of rescue SABAs or 2 treatments with a nebulized beta-2-agonist per day on 2 consecutive days within 4 weeks prior to Screening Required more than 2 courses of oral/systemic corticosteroids for asthma within 12 months prior to Screening Have a history of sleep disorders, including narcolepsy, or use of medications that affect alertness or sleep Have sleep apnea, obstructive sleep apnea-hypopnea, or are being treated with the ventilation devices Continuous Positive Airway Pressure (CPAP) or (Bi-level Positive Airway Pressure (Bi-PAP), or are receiving oxygen by inhalation Are smokers or ex-smokers who have smoked within 6 months prior to Screening or have a cumulative smoking history of 10 pack-years or greater
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1
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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.
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eligible ages (years): 18.0-999.0, Asthma History of asthma attacks Forced expiratory volume in 1 second (measure of how well the lungs are working) is greater than 60% of the predicted value Asthma is not stable: patients were admitted to hospital or received emergency room treatment Patients whose asthma drugs need changing within the month prior to the start of the study
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2
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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.
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eligible ages (years): 18.0-50.0, Mild Asthma Allergy A history of episodic wheezing, chest tightness, or shortness of breath consistent with asthma, or physician diagnosed asthma. 2. Specific allergy to house dust mite Dermatophagoides farinae confirmed by positive immediate skin test response. 3. Provocative concentration of methacholine of 10 mg/ml or less producing a 20% fall in FEV1 (PC20 methacholine) by the method used in a separate screening protocol (98-CEMLB-293) that is already approved by the UNC IRB. 4. 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 mild episodic or mild persistent asthma Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, or chronic thyroid disease. 2. Subjects with a history of immunologic disease, or undergoing therapeutic immune suppression for cancer or other diseases. 3. Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months. 4. Use of systemic steroid therapy within the preceding 12 months for asthma or the following asthma symptoms; cough, wheeze, shortness of breath. 5. Use of inhaled steroids, cromolyn or leukotriene inhibitors (Montelukast or Zafirlukast) within the past month (except for use of cromolyn exclusively prior to exercise). 6. Use of daily theophylline within the past month. 7. Use of medications that might alter the response to methacholine or antigen challenge including anti-inflammatory and anti-histamine agents within one week of challenge. 8. Subjects using tricyclic antidepressants such as doxepin and MAO inhibitors. 9. Subjects using beta-adrenergic blockers or any other medications known to interfere with the treatment of anaphylaxis. 10. Inability to withhold inhaled or oral bronchodilating medications for 12 hours prior to allergen challenge. 11. Pregnancy (positive urine pregnancy test at the baseline visit) or nursing a baby. Pregnant women are excluded due to the risk of fetal exposure to radiation. 12. Women of child bearing potential who are not using dependable contraception (such as birth control pill, IUD, estrogen patches) or who are not completely abstinent. 13. Cigarette smoking >0.5 packs per week within the past 12 months. 14. Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. 15. Exacerbation of asthma more than 2x/week which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. 16. Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. (Not to prophylactic use of albuterol prior to exercise). 17. Viral upper respiratory tract infection within 4 weeks of challenge. 18. Any acute infection requiring antibiotics within 2 weeks of challenge (or 4 weeks in the case of azithromycin due to the prolonged half-life). 19. Participating in any study utilizing an investigational agent within 4 weeks of this challenge
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0
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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.
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eligible ages (years): 0.0-999.0, Respiratory Tract Infections Common Cold Households which at least three persons, at least one of whom is a preschool child, living in Northern Manhattan, have a telephone, speak Spanish or English
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0
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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.
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eligible ages (years): 18.0-999.0, Cough Gastroesophageal Reflux age > 18 years old able to speak and read English chronic cough Cigarette smoking within the past 6 months, or greater than 10 pack year history of prior smoking Any self-reported or clinically diagnosed form of active lung disease, including asthma and emphysema Symptoms of persistent rhinitis within the past three months Dysphagia Symptoms of acute viral upper respiratory tract infection or sinusitis within one month of entry into the study Pregnancy based on self report Abnormal chest radiograph
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0
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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.
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eligible ages (years): 12.0-999.0, Asthma Subjects eligible for enrollment in the study must meet all of the following 1. Consent: A signed and dated written informed consent must be obtained from the subject and/or subject's legally acceptable representative prior to study participation. 2. Type of Subject: Outpatient 3. Gender: Male or female Females are eligible to participate only if they are currently non-pregnant and non-lactating. A female is eligible to enter and participate in the study if she is: 1. of non-child-bearing potential; OR 2. of child-bearing potential but has a negative urinary pregnancy test at Screening (Visit 1 and when specified in Appendix 1) and agrees to take contraceptive precautions (including abstinence) which are adequate to prevent pregnancy during the study. Acceptable methods of contraception [Hatcher, 2004] are Abstinence oral contraceptive (either combined or progestogen only) injectable progestogen implants of levonorgestrel estrogenic vaginal ring percutaneous contraceptive devices intrauterine device (IUD) or intrauterine system (IUS) with published data showing that the lowest expected failure rate is less than 1% per year male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study and is the sole sexual partner for that female subject double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent 1. Age: A subject must be 12 years of age at Visit 1 (screening). 2. Asthma Diagnosis: A documented diagnosis of persistent asthma, for at least six months, as defined by the following American Thoracic Society definition: Asthma is a clinical syndrome characterized by increased responsiveness of the airways to a variety of stimuli. The major symptoms of asthma are episodes of dyspnea, wheezing, and cough, which may vary from mild and almost undetectable to severe and unremitting (status asthmaticus). The primary physiological manifestation of this hyperresponsiveness is variable airway obstruction. This can take the form of spontaneous fluctuations in the severity of obstruction, substantial improvements in the severity of obstruction following bronchodilators or corticosteroids, or increased obstruction caused by drugs or other stimuli [American Thoracic Society, 1987]. 1. Asthma Medication History: A subject must be using a low to medium dose of an ICS (Table 1) OR a combination of controller medications (Table 2), containing a low (total daily) dose ICS (as defined in Table 1) for at least 4 weeks preceding screening. Table 1 (ICS Dosage Table) Inhaled Corticosteroid (Dosage (mcg/day))(LowMedium) Beclomethasone dipropionate CFC (168 = 504> 504 = 840) Beclomethasone dipropionate HFA (80 = 240>240 = 640) Triamcinolone acetonide (400 = 1000>1000 = 2000) Flunisolide (500 = 1000> 1000 = 2000) Fluticasone propionate inhalation aerosol (176 = 220> 220 = 440) Fluticasone propionate inhalation powder (100 = 250> 250 = 500) Budesonide1 (200 = 600> 600 =1200) Mometasone (200 = 400> 400 = 800) Ciclesonide (80 = 160>160 = 320) 1.Respules are allowed at a dosage of 250-500mcg/day. Table 2 (Asthma Controller Medications) Asthma Controller Medication(s) Low dose ICS + Leukotriene modifiers Low dose ICS + Theophylline products Low Dose ICS + Inhaled anticholinergics or combination products (e.g., Atrovent or Combivent) Low Dose ICS + Long acting inhaled anticholinergic (e.g. Spiriva) Low dose ICS+ long acting beta agonist or combination products containing a low dose ICS and a long-acting beta-agonists (e.g. 100/50 mcg BID or Symbicort 160/9 mcg BID (i.e 80/4.5 mcg two inhalations BID) 1.ADVAIR/SERETIDE =250/50 mcg BID or Symbicort 320/9 mcg BID (i.e 160/4.5 mcg two inhalation BID) are not permitted. 1. Pulmonary function: A pre-albuterol (salbutamol) FEV1 of 50% and 85% of predicted normal value at screening (Visit 1) after withholding asthma medications as detailed in the protocol (Section 6.8.1). Predicted FEV1 will be based on the National Health and Nutrition Examination Survey (NHANES III) predicted normal values for ages 8 years and older [Hankinson, 1999]. 2. Reversibility: An increase in FEV1 of 12% over the pre-albuterol (salbutamol) FEV1 within 30 minutes after the inhalation of 2-4 puffs of albuterol (salbutamol). Historical documentation of reversibility will not be permitted. 3. Asthma symptom Each subject must have experienced asthma symptoms requiring albuterol (salbutamol) use within the 4 weeks preceding screening (Visit 1). Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product that may impact subject is provided in the IB and the product labels Subjects meeting any of the following must not be enrolled in the study: 1.Life-Threatening Asthma: A subject must not have life-threatening asthma. Life-threatening asthma is defined for this protocol as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, or hypoxic seizures, or asthma-related syncopal episode(s) within the 12 months prior to screening (Visit 1). 2.Worsening of Asthma: A subject must not have experienced a worsening of asthma which involved an ER visit, hospitalization or use of oral/parenteral corticosteroids within 4 weeks of screening (Visit 1). 3.Intermittent, Seasonal, or Exercise-Induced Asthma Alone: Subjects with only intermittent or seasonal or exercise-induced asthma are excluded from participation in this study. 4.Concurrent Respiratory Disease: A subject must not have current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities other than asthma. 5.Concurrent Conditions/Diseases: A subject with historical or current evidence of any clinically significant, co-morbid or 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 results if the condition/disease exacerbated during the study. The list of excluded conditions/diseases includes, but is not limited to: congestive heart failure known aortic aneurysm clinically significant coronary clinically significant cardiac arrhythmia heart disease stroke within 3 months of screening (Visit 1) uncontrolled hypertension coronary artery disease hematologic, hepatic, or renal disease cystic fibrosis poorly controlled peptic ulcer dyspnea by any other cause than asthma gastroesophageal reflux disease (GERD) not controlled by pharmacotherapy and may be causing/contributing to subject's respiratory symptoms thyrotoxicosis hypokalemia immunologic compromise current malignancy1 tuberculosis (current or quiescent) Cushing's or Addison's disease pneumonia, pneumothorax, chronic bronchitis or atelectasis uncontrolled diabetes mellitus recent history of drug or alcohol abuse 1.history of malignancy is acceptable only if subject has been in remission for one year prior to screening (Visit 1; remission = no treatment for the malignancy in the 12 months prior to screening [Visit 1]) 1. Drug Allergy: A subject must not have had any immediate or delayed hypersensitivity to any beta2-agonist; sympathomimetic drug; any intranasal; inhaled or systemic corticosteroid therapy; lactose; or have a severe milk protein allergy. 2. Respiratory Tract Infections: A subject must not have had any sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection symptoms that have not resolved at least 7 days immediately preceding screening (Visit 1). 3. Asthma Medications: Asthma medications listed below must not have been used prior to screening (Visit 1) for the required period as indicated below: Medication (Exclusion Period Prior to screening (Visit 1)) Oral or parenteral systemic corticosteroids (4 weeks) Omalizumab (Xolair) (6 months) 1. Concurrent Medications: A subject must not have the concurrent use of any of the following medications that interact with any of the study drugs used in this study, or that may affect the course of asthma or interact with sympathomimetic amines, such as beta-adrenergic receptor blocking agents monoamine oxidase (MAO) inhibitors tricyclic antidepressants ritonavir ketoconazole 2. Concurrent use of asthma medications: Concurrent use of all asthma medications (other than protocol defined study and rescue medications and oral/parenteral corticosteroids) are prohibited during the study. 3. Concomitant use of leukotriene modifiers (LTM) for allergies is prohibited. A subject must not be on LTM for treatment of nasal allergies that requires regular maintenance therapy. Substitution with any other antihistamine is permitted. 4. Immunosuppressive Medications: A subject must not be using, or require the use of, immunosuppressive medications during the study. 5. Immunotherapy for the treatment of allergies is not allowed during the study unless the subject has used a constant dose for 4 weeks prior to Screening (Visit 1) and the same dose will be continued throughout the study. 6. Tobacco Use: >10 pack year history or use of any tobacco products within 1 year of screening (Visit 1). This includes cigarettes, cigars, pipe, chewing tobacco, and snuff. 7. Questionable Validity of Consent: A subject must not have any infirmity or disability that would limit the subject's consent. 8. Positive Pregnancy Test (for all females who have had menarche): A current positive pregnancy test. 9. Investigational Medications: A subject must not have had use of any investigational drug within 30 days of screening (Visit 1). 10. Site Affiliation: A subject may not participate if he/she is a participating investigator, sub-investigator, study coordinator, employee of a participating investigator or is in any way associated with the administration of the study. Immediate family members of these individuals are also excluded. 11. Compliance with Study Requirements: A subject may not participate if, in the opinion of the investigator, there are present or anticipated circumstances that will prohibit the subject from being compliant with study visits and procedures (e.g. geographic location that will prohibit subject from required clinic visit schedule)
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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.
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eligible ages (years): 12.0-999.0, Asthma Subjects eligible for enrollment in the study must meet all of the following Consent: A signed and dated written informed consent must be obtained from the subject and/or subject's legally acceptable representative prior to study participation Type of Subject: Outpatient Gender: Male or female Females are eligible to participate only if they are currently non-pregnant and non-lactating. A female is eligible to enter and participate in the study if she is: 1. of non-child-bearing potential; OR 2. of child-bearing potential but has a negative urinary pregnancy test at Screening (Visit 1 and when specified in Appendix 1) and agrees to take contraceptive precautions (including abstinence) which are adequate to prevent pregnancy during the study. Acceptable methods of contraception [Hatcher, 2004] are Abstinence oral contraceptive (either combined or progestogen only) injectable progestogen implants of levonorgestrel estrogenic vaginal ring percutaneous contraceptive devices Subjects meeting any of the following must not be enrolled in the study: 1. Life-Threatening Asthma: A subject must not have life-threatening asthma. Life-threatening asthma is defined for this protocol as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, or hypoxic seizures, or asthma-related syncopal episode(s) within the 12 months prior to screening (Visit 1). 2. Worsening of Asthma: A subject must not have experienced a worsening of asthma which involved an ER visit, hospitalization or use of oral/parenteral corticosteroids within 4 weeks of screening (Visit 1). 3. Intermittent, Seasonal, or Exercise-Induced Asthma Alone: Subjects with only intermittent or seasonal or exercise-induced asthma are excluded from participation in this study. 4. Concurrent Respiratory Disease: A subject must not have current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities other than asthma. 5. Concurrent Conditions/Diseases: A subject with historical or current evidence of any clinically significant, co-morbid or 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 results if the condition/disease exacerbated during the study. The list of excluded conditions/diseases includes, but is not limited to: congestive heart failure known aortic aneurysm clinically significant coronary clinically significant cardiac arrhythmia heart disease stroke within 3 months of screening (Visit 1) uncontrolled hypertension coronary artery disease hematologic, hepatic, or renal disease cystic fibrosis poorly controlled peptic ulcer dyspnea by any other cause than asthma gastroesophageal reflux disease (GERD) not controlled by pharmacotherapy and may be causing/contributing to subject's respiratory symptoms thyrotoxicosis hypokalemia immunologic compromise current malignancy1 tuberculosis (current or quiescent) Cushing's or Addison's disease pneumonia, pneumothorax, chronic bronchitis or atelectasis uncontrolled diabetes mellitus recent history of drug or alcohol abuse 1) history of malignancy is acceptable only if subject has been in remission for one year prior to screening (Visit 1; remission = no treatment for the malignancy in the 12 months prior to screening [Visit 1]) Drug Allergy: A subject must not have had any immediate or delayed hypersensitivity to any beta2-agonist; sympathomimetic drug; any intranasal; inhaled or systemic corticosteroid therapy; lactose; or have a severe milk protein allergy Respiratory Tract Infections: A subject must not have had any sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection symptoms that have not resolved at least 7 days immediately preceding screening (Visit 1). 3. Asthma Medications: Asthma medications listed below must not have been used prior to screening (Visit 1) for the required period as indicated below: Medication (Exclusion Period Prior to screening (Visit 1)) Oral or parenteral systemic corticosteroids (4 weeks) Omalizumab (Xolair) (6 months) 1. Concurrent Medications: A subject must not have the concurrent use of any of the following medications that interact with any of the study drugs used in this study, or that may affect the course of asthma or interact with sympathomimetic amines, such as beta-adrenergic receptor blocking agents monoamine oxidase (MAO) inhibitors tricyclic antidepressants ritonavir ketoconazole 2. Concurrent use of asthma medications: Concurrent use of all asthma medications (other than protocol defined study and rescue medications and oral/parenteral corticosteroids) are prohibited during the study. 3. Concomitant use of leukotriene modifiers (LTM) for allergies is prohibited. A subject must not be on LTM for treatment of nasal allergies that requires regular maintenance therapy. Substitution with any other antihistamine is permitted. 4. Immunosuppressive Medications: A subject must not be using, or require the use of, immunosuppressive medications during the study. 5. Immunotherapy for the treatment of allergies is not allowed during the study unless the subject has used a constant dose for 4 weeks prior to Screening (Visit 1) and the same dose will be continued throughout the study. 6. Tobacco Use: >10 pack year history or use of any tobacco products within 1 year of screening (Visit 1). This includes cigarettes, cigars, pipe, chewing tobacco, and snuff. 7. Questionable Validity of Consent: A subject must not have any infirmity or disability that would limit the subject's consent. 8. Positive Pregnancy Test (for all females who have had menarche): A current positive pregnancy test. 9. Investigational Medications: A subject must not have had use of any investigational drug within 30 days of screening (Visit 1). 10. Site Affiliation: A subject may not participate if he/she is a participating investigator, sub-investigator, study coordinator, employee of a participating investigator or is in any way associated with the administration of the study. Immediate family members of these individuals are also excluded. 11. Compliance with Study Requirements: A subject may not participate if, in the opinion of the investigator, there are present or anticipated circumstances that will prohibit the subject from being compliant with study visits and procedures (e.g. geographic location that will prohibit subject from required clinic visit schedule)
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1
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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.
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eligible ages (years): 18.0-60.0, Asthma Men or women of non-child bearing potential, aged between 18 and 60 years of age inclusive Body weight = 50 kg (110 lbs) for men and = 45 kg for women and Body Mass Index (BMI) within the range 19.0-30.0 kg/m2 inclusive The subject is a current non-smoker who has not used any tobacco products in the last year A signed and dated written informed consent is obtained for the subject The subject is able to understand and comply with protocol requirements and timetables, instructions and protocol-stated restrictions If asthmatic, the subject must be a clinically stable asthmatic The subject has a history of allergy to ingredients within the inhaler The subject has received an investigational drug or participated in any other research trial within 30 days, prior to the first dose of current study medication The subject has used prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 14 days prior to the first dose of study medication The subject has an average weekly alcohol intake of greater than 21 units if male or 14 units if female The subject has any history of breathing problems (e.g. history of asthmatic symptoms) The subject is infected with the hepatitis B, hepatitis C, or HIV virus The subject has had a respiratory tract infection or worsening of asthma within 4 weeks of the start of the study The subject has a past or present disease, which as judged by the Investigator, may affect the outcome of this study The subject has a history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxia seizures The subject has taken inhaled, nasal or dermal steroids within 4 weeks or oral steroids within 8 weeks of the start of the study
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1
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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.
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eligible ages (years): 18.0-50.0, Asthma Positive skin prick test History of asthma (GINA) Regular treatment with FP with/without LABA at least 4 weeks before visit 1 History of recurrent episodes of wheezing, breathlessness, chest tightness and/ or coughing in the previous year Able to use a inhaler Able perform reproducible lung function tests at Visit 1 treatment period FEV1 % predicted > 70% ACT score < 25 after run-in period run-in period Hospitalised for asthma within 4 weeks prior to Visit 1 Acute upper respiratory tract infection or a lower respiratory tract infection within 4 weeks prior to Visit 1 Oral, parental or depot corticosteroids within 4 weeks prior to Visit 1 Hepatic impairment or other significant disease treatment period Non-compliance (< 70%)
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1
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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.
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eligible ages (years): 3.0-7.0, Asthma 5-6.9 year-old children who were asthmatic according to GINA guidelines All children previously had recurrent episodes of wheeze, cough and/or shortness of breath with clinical response to bronchodilator Children were included only if they had not received anti-inflammatory medication for at least one week prior to the test or bronchodilators for at least 24 hours prior to the study On the day of testing, children were included if they had normal chest auscultation and FEV1>75% predicted for healthy preschool children Presence of other chronic respiratory conditions Emergency room visit in the past three months Respiratory infection in the past month
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0
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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.
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eligible ages (years): 18.0-999.0, Seasonal Allergic Rhinitis history of seasonal allergic rhinitis symptoms to pollen positive skin prick test to pollen negative history of seasonal allergic asthma male or female older than 18 female participants must use appropriate contraception able to comply to study procedures pregnancy alcohol or drug abuse subject receiving antihistamines , immunotherapy or on hyposensibilisation
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2
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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.
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eligible ages (years): 6.0-17.0, Asthma At Enrollment (V0) Age 6-17 years at time of enrollment. A goal of 33% minority and 40% female subjects will be incorporated in recruitment Weighs at least 25 kg Asthma diagnosed by a physician and present for at least one year prior to study entry Moderate to severe persistent asthma: 1. Patients will be identified in the following general categories. The general principle is that patients will be uncontrolled on a relatively low dose of ICS that can be stepped-up, or controlled on a moderate or high dose of ICS that can be stepped-down. i) On low dose ICS with or without salmeterol and uncontrolled. This patient will be treated with budesonide and salmeterol to determine criteria. If the addition of salmeterol results in control of symptoms, the patient would be excluded from MARS. If control was not established on low dose budesonide and salmeterol, the dose of budesonide would be increased and entry evaluated based on the algorithm in Figure 1. ii) On a dose of ICS equivalent to budesonide at 400 mcg per day with or without any other medication and uncontrolled. This patient will be treated with budesonide and salmeterol to determine criteria. iii) On a dose of ICS equivalent to budesonide at 800 mcg per day with or without any other medication and controlled. iv) On a dose of ICS equivalent to budesonide at 1600 mcg per day with or without any other medication and uncontrolled but not requiring prednisone acutely. These patients will be followed to see if they become well controlled with increased adherence or more careful monitoring of symptoms. 2. Examples are given for Advair as this drug is a commonly used form of ICS and LABA: i) Patients on Advair 100/50 bid and inadequately controlled ii) Patients on Advair 250/50 bid and inadequately controlled iii) Patients on Advair 250/50 bid and well controlled for greater than 3 months and being considered for stepping-down to Advair 100/50 iv) Patients well controlled on Advair 100/50 bid + either montelukast or theophylline for greater than 3 months and being considered for stepping-down to Advair 100/50 bid alone v) Patients on Advair 500/50 bid and well controlled for greater than 3 months and being considered for stepping-down to Advair 250/50 vi) Patients well controlled on Advair 250/50 bid + either montelukast or theophylline for greater than 3 months and being considered for stepping-down to Advair 250/50 bid alone 3. Patients on an equivalent of budesonide 400 mcg, 800 mcg, or 1600 mcg per day with no symptoms, but with an FEV1 less than 80% predicted, will be enrolled as uncontrolled and observed closely for symptoms or low peak flows for 2 weeks. The rationale for enrolling these patients and observing them as "uncontrolled" is that patients with an FEV1 below the range of normal may be having symptoms and/or low peak flows that will become apparent under close observation after appropriate education. Note that a percent predicted value for FEV1 will be used only at the enrollment visit, with for control and inadequate control during both run-in and during the double-blind portions of the study using the highest FEV1 value obtained during run-in for decisions prior to randomization and the FEV1 at randomization for decisions subsequent to that visit FEV1 at least 80% predicted if there is going to be step-down at enrollment or at least 50% predicted if already suboptimally controlled historically and to be observed for 2 weeks to define baseline symptoms. FEV1 measurements will be obtained pre-bronchodilator Demonstrate a bronchodilator response with an improvement in FEV1 of at least 12% or airway responsiveness to methacholine with a PC20 less than 12.5 mg/ml. 1. Bronchodilator responsiveness testing will be done at Visit 0 (Enrollment) in all patients using 4 puffs albuterol. 2. Methacholine challenge will be done at Visit 1 (Step-up) in patients who did not respond to bronchodilator at Visit 0. Patients with a FEV1 less than 70% predicted or an upper respiratory infection at the time of Visit 1 will have a second bronchodilator challenge rather than a methacholine Varicella immunization complete (unless the subject has already had clinical varicella). If the subject needs varicella vaccine, this will be arranged with the primary care physician and must be received prior randomization Willingness to provide informed consent by the child's parent or guardian Nonsmoker in the past year; in addition, no use of smokeless tobacco products in the year prior to study entry At Enrollment (V0) More than four courses of systemic corticosteroids for asthma during the 12 months prior to study entry More than one hospitalization for wheezing illnesses within the 12 months prior to study entry Current treatment with antibiotics for diagnosed sinus disease History of severe sinusitis requiring sinus surgery within the past 12 months Use of maintenance oral or systemic antibiotics for treatment of an ongoing condition Use of macrolide antibiotics within the 6 weeks prior to study entry Requirement for prednisone therapy for concurrent illness, e.g., RA, SLE, IBD Asthma exacerbation requiring systemic corticosteroids within 4 weeks of study entry Contraindication for use of macrolide or LTRA
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1
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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.
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eligible ages (years): 45.0-90.0, Lung Diseases Bronchitis, Chronic Male or female out-patients >/= 45 years Subjects suffering from chronic bronchitis FEV1</= 70% and FEV1/FVC </= 70% predicted from age, height and sex No documented episode of AECB (requiring treatment) within 6 weeks of randomization and not experiencing an exacerbation at the time of screening Sputum production on most days, even when exacerbation free Subjects presented with at least two documented (i.e. requiring antibiotics and/or systemic steroid administration) acute exacerbation episodes during the last 12 monthsIf receiving chronic therapy with inhaled long acting bronchodilators and/or inhaled or systemic steroids, the treatment must have remained stable for the preceding 6 weeks prior to screening Smoking history of at least 20 pack-years Subjects willing and able to give fully informed written consent Subjects with contra-indications to moxifloxacin Known bronchial carcinoma, pulmonary tuberculosis, cystic fibrosis, documented chronic bronchial asthma or diffuse bronchiectasis Subjects who are actively participating in intensive pulmonary rehabilitation programs Subjects with a known history of chronic colonization of pathogenic organisms resistant to moxifloxacin, e.g. Pseudomonas spp, MRSA No systemic or inhaled antibiotic therapy during the 6 weeks prior to screening and any long term antibiotic usage Subjects requiring home ventilatory support for COPD and those who have a tracheostomy in situ (subjects requiring home/potable oxygen therapy or CPAP for sleep apnea can be included)
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0
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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.
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eligible ages (years): 18.0-70.0, Asthma Documented clinical history of asthma Forced expiratory volume in 1 second between 60% and 90% of predicted Using an inhaled corticosteroid (ICS)at a dose equivalent to 200 to 500 mcg daily of beclomethasone (BDP)or equivalent combined with a long-acting beta-2-agonist or an ICS alone at a dose equivalent to >500 to 1000mcg daily of BDP daily Lower respiratory tract infection within 1 month of study entry Use of systemic corticosteroids within 1 month of study entry Smoking history of 10 pack years or more Changes in regular asthma therapy within 12 weeks of study entry Any significant disorder that in the investigator's opinion might put the patient at risk or influence the study outcomes
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2
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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.
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eligible ages (years): 18.0-999.0, Allergic Asthma diagnosed with stable, mild, allergic asthma history of episodic wheeze and shortness of breath sexually active women of childbearing potential must use contraceptive during the entire duration of study willing and able to give informed consent positive methacholine challenge positive skin prick test to common aeroallergens positive allergen-induced early and late phase bronchoconstrictor response FEV1 at least 70% of predicted value PC20 at baseline that is within 1 doubling dose of that measured during screening active bacterial infection
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1
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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.
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eligible ages (years): 6.0-14.0, Asthma, Bronchial Patient is male or female, 6-14 years of age with mild persistent asthma Patient has a history of the following symptoms: wheezing, chest tightness, cough, etc Patient has asthma diagnosed by a doctor Patient is hospitalized Patient has had major surgery or participated in another clinical trial in the last 4 weeks Patient has been on a breathing tube for asthma
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1
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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.
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eligible ages (years): 18.0-999.0, Asthma for and TALC Studies Clinical history consistent with asthma Forced expiratory volume in one second (FEV1) greater than 40% of predicted value Asthma confirmed by one of the following two 1. Beta-agonist reversibility to 4 puffs albuterol of at least 12% OR 2. Methacholine provocative concentration at 20% (PC20) FEV1 of 8 milligrams per millimeter (mg/mL) or less when not on an inhaled corticosteroid, or 16 mg/mL or less when on an inhaled corticosteroid Need for daily controller therapy (i.e., inhaled corticosteroids, leukotriene modifiers, and/or long-acting beta-agonists) based on one or more of the following 1. Received prescription for or used asthma controller within the 12 months prior to study entry OR 2. Experienced symptoms for more than twice a week and not on asthma controller If on inhaled steroids (any drug at any dose not exceeding the equivalent of 1000 micrograms (mcg) of fluticasone daily), participant must have been on a stable dose for at least 2 weeks prior to study entry Non-smoker (i.e., total lifetime smoking history less than 10 pack-years; no smoking for at least 1 year prior to study entry) Willing to use an effective form of birth control throughout the study for Study Ability to measure peak expiratory flow (PEF) each morning using the electronic peak flow meter (EPFM) device and to accurately transcribe the PEF measurements onto the diary cards at least 75% of the time during the last 2 weeks of the adherence testing period compliance with recording peak flow measurements and symptoms in a symptom diary during the last 2 weeks of the adherence testing period for and TALC Studies Lung disease other than asthma, including chronic obstructive pulmonary disease (COPD) and chronic bronchitis Established or suspected diagnosis of vocal cord dysfunction Significant medical illness other than asthma History of respiratory tract infection within the 4 weeks prior to study entry History of a significant exacerbation of asthma within the 4 weeks prior to study entry History of life-threatening asthma requiring treatment with intubation and mechanical ventilation in the 5 years prior to study entry Hyposensitization therapy other than an established maintenance regimen Inability to coordinate use of the delivery devices used in the study, based on the opinion of the investigator or clinical coordinator Pregnant
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1
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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.
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eligible ages (years): 1.0-4.0, Bronchial Asthma Patients will be enrolled into the 2-week placebo run-in period if they meet all the following Age ≥ 1 year and ≤ 4 years At least 3 episodes of wheeze or asthma-like symptoms in the 6 months preceding the study entry A cooperative attitude and ability to be trained to inhale correctly from the device and to complete the diary cards Written parental/guardian informed consent obtained. Patients will be then randomised to the treatment period if they meet all the previous plus Presence in at least 7 days out of the 14 days of the run-in period of at least one of the following symptoms: wheeze, cough or shortness of breath; or had required at least one dose of relief salbutamol History of severe asthma exacerbation or exacerbations requiring hospitalisation in the previous 4 weeks Symptomatic infection of the airways requiring treatment with antibiotics or antimycotics in the previous 4 weeks Treatment with inhaled steroids in the previous 4 weeks or oral steroids in the previous 8 weeks Treatment with methyl-xantine derivatives in the previous 4 weeks Treatment with long-acting β2-agonists in the previous 2 weeks Changes in asthma medications taken on regular basis in the previous 4 weeks Symptoms of asthma limited to seasonal allergen exposure History of clinically significant cardiac, renal, neurologic, hepatic, endocrine or pulmonary disease (except asthma), or laboratory testing abnormalities, whose sequelae and/or treatments can interfere with the results of the present study Evidence of pulmonary malformations Evidence of immunological deficiency (patients to be withdrawn if diagnosed during the study)
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1
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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.
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eligible ages (years): 18.0-70.0, Asthma Are between 18 and 70 years of age at the time of signing the informed consent Have a diagnosis of asthma according to the Guidelines for the Diagnosis and Management of Asthma and have not been treated with ICS in the previous two months Have a PC20 methacholine less than 8 mg/ml Have a baseline FEV1 greater or equal to 65% of predicted value (at least 6 hours after bronchodilator) Are not optimally controlled with short-acting 2 agonists as shown by awakenings due to asthmatic symptoms at least once a week, or regular use of salbutamol on 4 or more occasions per week (excluding exercise prophylaxis) due to asthma symptoms ACQ score equal or greater than 2 Have sputum eosinophils less than 2% Are non smokers or ex-smokers who smoked a maximum of 10 pack/year Hospitalized patients within the last 3 months Current or recent (within the last month) symptoms of a cold or flu Patients with a history of near fatal asthma Subjects on inhaled corticosteroids, prednisone, long-acting beta 2 agonists, montelukast or theophylline, within 2 months prior to entry into the study
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1
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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.
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eligible ages (years): 12.0-999.0, Asthma Patient with poorly controlled asthma Patient under age of 12 Not possessing a mobile phone and who don't have adequate command of the English language
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2
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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.
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eligible ages (years): 18.0-999.0, Pharmacokinetics Healthy adults Patients with Allergic Rhinitis Under age 18
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1
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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.
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eligible ages (years): 18.0-999.0, Asthma Age 18 years or older History of moderate or severe and persistent asthma Currently being treated with a long acting beta agonist and inhaled corticosteroid FEV1 > or = 70% at randomization visit (pulmonary function test result) Women of childbearing potential must be on an effective form of contraception Ability to read and understand English Active smoking or greater than 10-pack-year history of smoking History of intubation for asthma within the past 10 years Patients who are pregnant, become pregnant during the study or are breast feeding Major comorbidity including: severe cardiac disease, uncontrolled hypertension, poorly controlled diabetes, malignancy within the past 5 years (except non-melanoma skin lesions), and pulmonary disease other than asthma
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1
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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.
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eligible ages (years): 12.0-999.0, Asthma Male and female patients aged ≥ 12 years (or ≥ 18 years depending upon regulatory and/or Institutional Review Board/Independent Ethics Committee/Research Ethics Board [IRB/IEC/REB] approval) who have signed an informed consent form. 2. Patients with moderate to severe persistent asthma, diagnosed according to the Global Initiative for Asthma (GINA) guidelines (Updated 2006) and who additionally meet the following Patients who have used treatment with a bronchodilator, either regularly or on-demand, and who had used a daily dose of at least 100 μg beclomethasone dipropionate (or equivalent) for at least 1 month prior to screening Patients whose forced expiratory volume in 1 second (FEV1) is ≥ 50% of the predicted normal value Patients with documented (in the previous 6 months) or who demonstrate (prior to randomization) a ≥ 12% and at least 200 ml increase in FEV1, after inhaling 200 μg salbutamol Pregnant or nursing (lactating) women and women of child-bearing potential they meet pre-specified definitions of post-menopausal or are using pre-specified acceptable methods of contraception. 2. Patients who have used tobacco products within the 12 month period prior to screening, or who have a smoking history of greater than 10 pack years. 3. Patients who suffer from chronic obstructive pulmonary disease (COPD) as diagnosed by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (2006). 4. Patients who have had emergency room treatment for an acute asthma attack in the 6 weeks prior to screening or who have been hospitalized for an acute asthma attack in the 6 months prior to screening, or at any time between screening and Week 1. 5. Patients with diabetes Type I or those with uncontrolled diabetes Type II including patients with a history of blood glucose levels consistently outside the normal range or glycosylated hemoglobin (HbA1C) > 8.0% measured at screening. 6. Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically significant condition or a clinically relevant laboratory abnormality that might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study. 7. Patients with a history of long QT syndrome, or whose QTc interval (Bazett's formula) is prolonged to > 450 ms (males) or > 470 ms (females). 8. Certain medications for asthma and allied conditions such as long-acting bronchodilators must not be used prior to screening and for a pre-specified minimum washout period. Other protocol-defined inclusion/ applied to the study
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2
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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.
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eligible ages (years): 18.0-50.0, Allergic Rhinitis to 50 years of age (inclusive) Body Mass Index (BMI) between 18 and 28 kg/m2 History of pollen-induced seasonal allergic rhinitis for at least two years and otherwise healthy Elevated specific IgE to at least one aero allergen or at least one positive skin pick test (SPT) Seasonal allergic rhinitis with symptoms provoked by the allergen with a corresponding elevated specific IgE or positive SPT Signed written Informed Consent Perennial allergic rhinitis except for cat and/or dog sensitivity under the condition that these patients are not exposed to cats and dogs Soy bean allergy Peanut allergy Smoking during the last month before study Any upper respiratory tract infection during the period of 2 weeks before the start of the study Chronic medication Any medication, including herbal medicines, during their last five half-lives (t½) Nasal anatomical deviations Extensive use of nasal sprays as judged by the Investigator Ongoing nasal symptoms as judged by the Investigator
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2
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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.
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eligible ages (years): 18.0-999.0, Shortness of Breath Heart Failure Eighteen years of age or older The patients must be seen in the urgent care or emergency area with a chief complaint of shortness of breath not due to trauma Patient is unable to sign or understand the consent form Patient is on any dialysis Patient has trauma related shortness of breath (i.e. penetrating wounds, crush injury)
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0
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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.
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eligible ages (years): 18.0-45.0, Asthma Main Out-patients Written informed consent History of atopic disease History of perennial bronchial asthma for at least 6 months as defined by ATS Current use of only inhaled short acting beta-2-agonist as required (for at least 4 weeks prior to baseline period B0) Stable asthma, i.e. no exacerbation or relevant respiratory tract infection within 2 months prior to study start FEV1 ≥ 70% predicted Hyperreactivity to AMP (PC20FEV1 < 25 mg/ml) Good health with the exception of asthma Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids (e.g. lung tuberculosis) Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation Use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months Pregnancy or intention to become pregnant during the course of the study, breast feeding, lack of safe contraception in heterosexually active female patients of child-bearing potential, or postmenopausal for less than one year COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases Known or suspected hypersensitivity to inhaled steroids or to the other excipients of the metered dose inhalers Immunotherapy within one month prior to B0 and/or during the entire study duration
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1
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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.
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eligible ages (years): 18.0-80.0, Asthma COPD For all patients: 1. The patient understands the study procedures and agrees to participate by signing the consent form. 2. The patient is male or female, at least 18 years of age but no more than 80 years of age at the entry into the study (screening visit). For patients with asthma (groups 1 and 2) 1. The patient has a history of intermittent or persistent symptoms of wheezing, breathlessness, chest tightness and cough. The diagnosis of asthma must have been confirmed by a specialist in pulmonary medicine. 2. The patient fulfils one or several of the following for reversible airway obstruction, as documented during the last 5 years before the study or at screening visit: 1. An increase in FEV1 more than 9% of predicted (or improvement by 200 mL) after administration of 4 puffs of 100 microg salbutamol dose-aerosol inhaler via a spacer, or after additional inhalation of four puffs of 20 microg ipratropium bromide (Atrovent) administered through a large volume spacer. 2. A mean diurnal variation in Peak Expiratory Flow (PEF) of more than 15% on more than 4 days/week for at least 2 weeks, as calculated by the following equation: (highest PEF-lowest PEF)/mean PEF 3. An increase in FEV1 of at least 400 mL after a course of prednisolone 0.5mg/kg/day for 14 days. 4. In patients with a FEV1 more than 70% predicted, demonstrated bronchial hyperresponsiveness to histamine, methacholine, isocapnic hyperventilation, exercise or other indirect challenges (according to established local methods). 3. The patient is a non-smoker or has a total smoking history of less than 5 pack years. In the case the patient is smoking, it must be less than 10 cigarettes a day and the asthma must have started before smoking. Specific for patients with mild to moderate asthma (group 1) 1. The patient has stable disease with minimal symptoms, no exacerbations or hospitalisations during the last year. 2. The patient uses inhaled steroids regularly, but not more than 800 microg/day budesonide or beclomethasone, or up to 500 microg/day fluticasone. 3. The patient uses prescribed short-acting beta agonists as needed. 4. The patient does not require treatment with long-acting beta-agonists. Specific for patients with severe asthma (group 2) 1. The patient has been under specialist treatment for at least one year. 2. The patient requires continuous treatment with high doses of inhaled steroids. If the patient does not take oral steroids, the inhaled dose of steroids must be more than 1600 microg/day budesonide or beclomethasone, or more than 800 microg/day fluticasone or equivalent. In case the patient does take oral steroids, the inhaled dose of steroids must be more than 800 microg/day budesonide or beclomethasone, or more than 400 microg/day fluticasone or equivalent. 3. The patient requires continuous treatment with long acting inhaled beta-agonists or oral theophylline, as documented for at least one year. 4. The patient experienced at least one asthma exacerbation during the previous year. Specific for patients with COPD (group 3) 1. The diagnosis of COPD must have been made by a specialist in pulmonary medicine. The patient may or may not have chronic symptoms (cough, sputum production, dyspnoea). 2. The patient has a FEV1/Forced Vital Capacity (FVC) ratio of less than 70%. 3. The patient's post bronchodilator FEV1 value is more than 30% but less than 80% of predicted. 4. The patient has a smoking history of more than 15 pack years, either as current or ex-smoker. 5. The patient displays a negative reversibility test to inhaled bronchodilators as defined by an increase in FEV1 of less than 9% of predicted (or an improvement by less than 200 mL) after administration of 4 puffs of 100 microg salbutamol dose-aerosol inhaler via a spacer, and four puffs of 20 microg ipratropium bromide (Atrovent) administered through a large volume spacer. 6. The patient has no history of asthma. 7. The patient has no current allergy, as shown by a negative skin-prick test. 8. The patient has used inhaled steroids in the range 800-1600 microg/day (budesonide or equivalent) for at least 3 months prior to the study General exclusions 1. The patient is pregnant. 2. The patient has a recent history of incapacitating psychotic disorders. 3. The patient is a current or recent past abuser of alcohol or illicit drugs. 4. The patient has a history of malignancy, is known to be positive for HIV, or other states that are considered to interfere with study conduct or scientific interpretations. 5. The patient cannot read or comprehend written material, or is in the opinion of the investigator, for other reasons unlikely to understand and follow the study procedures. 6. The patient is mentally or legally incapacitated preventing informed consent from being obtained. Exclusions because of pulmonary disorders 1. The patient is unable to perform acceptable spirometry, peak flow measurements and/or complete diary cards in a satisfactory way during the period between visit 1 and visit 3B (optimisation period and prednisolone/placebo trial). If the patient is unable to use the electronic Peak Flow meters/Diary cards, it is acceptable to use an ordinary mechanical meter (e.g. Mini-Wright) together with a paper version of the diary card. Patients that are unable to use the mechanical meter and paper diary card during the period between visit 1 and 3B cannot enter the follow-up year. 2. The patient has, in addition to asthma or COPD, any other pulmonary disorder that according to the investigator would interfere with the study procedures or scientific evaluation (e.g. tuberculosis). 3. The patient suffers from chronic hypercapnic respiratory failure as indicated by an elevated pCO2 (>47 mm Hg or 6,25 kPa). In case of doubt this should be confirmed with pulse oximetry or blood gas sampling. Exclusions because of medications 1. The patient has received immunosuppressants other than corticosteroids (i.e., methotrexate, gold, troleandomycin, cyclosporin or any other experimental anti-inflammatory drug) within three months of study entry. 2. The patient is currently undergoing immunotherapy. 3. The patient receives chronic oxygen therapy. Specific criterion for patients with asthma (groups 1 & 2) 1. The patient has smoked more than five (5) pack years. Specific criterion for patients with mild asthma (group 1) 1. The patient requires treatment with long-acting beta-agonists. Specific for patients with severe asthma (group 2) 1. The patient is not treated with high doses of inhaled steroids (see above). 2. The patient has not had an exacerbation of asthma during the last year. 3. The patient does not require treatment with long-acting beta-agonists or theophylline as documented during one year. Specific criterion for patients with COPD (group 3) 1. The patient has a history of asthma confirmed by a specialist in pulmonary medicine. Specific for bronchoscopy (all groups) 1. The patient has had a severe exacerbation of asthma requiring high doses of oral steroids during the last three (3) months. 2. The patient has had a severe exacerbation of COPD requiring intensive outpatient treatment or hospitalisation during the last three (3) months. 3. The patient has had three or more severe exacerbations of asthma or COPD during the last year. 4. The patient displays more than 10% fall in FEV1 at 2 minutes after inhalation of 0.9% saline (during induction of sputum at visit 2). 5. The patient has shown signs of uncontrolled disease during the last three days, e.g. the patient has required more than four puffs/day of rescue medication above baseline use during the last three days. (In the case 1-4 are not met, such patients may be rescheduled for bronchoscopy in two weeks time. The start of the oral prednisolone intervention will then be postponed by the number of days passing before the bronchoscopy). 6. If a patient who otherwise has qualified for bronchoscopy has received more than 6 mg per kg BW of lidocaine during the preparation for the procedure, the bronchoscopy must be terminated and cannot be continued the same day. 7. Patients who have experienced severe bronchoconstriction or other adverse reactions at previous attempts to perform bronchoscopy. 8. The patient has a post-bronchodilator FEV1 < 40% predicted. 9. Do not start or proceed bronchoscopy if Transcutaneous oxygen saturation by pulse-oximeter < 90% (despite giving oxygen by nasal cannula when saturation is < 94%) Heart frequency > 130 Heart rhythm disturbances. Specific for induced sputum (all groups) 1. A post-bronchodilator (after administration of 4 puffs of 100 microg salbutamol dose-aerosol inhaler via a spacer) FEV1 percent of predicted being less than 60%, or in absolute values less than 1.0 L. 2. A peak flow variability of more than 30% during the previous four days. 3. Patients who display more than a 15% fall in FEV1 at 2 minutes after inhalation of saline (0.9% NaCl) during induction of sputum.. 4. Patients who have experienced severe bronchoconstriction or other adverse reactions at previous attempts to induce sputum
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2
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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.
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eligible ages (years): 18.0-999.0, Asthma for TALC and Studies Clinical history consistent with asthma Forced expiratory volume in one second (FEV1) greater than 40% of predicted value Asthma confirmed by one of the following two 1. Beta-agonist reversibility to 4 puffs albuterol of at least 12% OR 2. Methacholine provocative concentration at 20% (PC20) of 8 milligrams per milliliter (mg/mL) or less when not on an inhaled corticosteroid (ICS), or 16 mg/mL or less when on an ICS Need for daily controller therapy (i.e., ICS, leukotriene modifiers, and/or long-acting beta-agonists) based on one or more of the following 1. Received prescription for or used asthma controller within the 12 months prior to study entry OR 2. Experienced symptoms for more than twice a week and not on asthma controller If on inhaled steroids (any drug at any dose not exceeding the equivalent of 1000 micrograms (mcg) of fluticasone daily), participant must have been on a stable dose for at least 2 weeks prior to study entry Non-smoker (i.e., total lifetime smoking history less than 10 pack-years; no smoking for at least 1 year prior to study entry) Willing to use an effective form of birth control throughout the study for TALC Study Ability to measure morning (AM) peak expiratory flow (PEF) on schedule using electronic peak flow meter (EPFM) and to complete the study diary correctly at least 75% of the time during the interval between Weeks 2 and 4 of the run-in period Adherence with study medication dosing at least 75% of the time during the interval between Weeks 2 and 4 of the run-in period for and TALC Studies Lung disease other than asthma, including chronic obstructive pulmonary disease (COPD) and chronic bronchitis Established or suspected diagnosis of vocal cord dysfunction Significant medical illness other than asthma History of respiratory tract infection within the 4 weeks prior to study entry History of a significant asthma exacerbation within the 4 weeks prior to study entry History of life-threatening asthma requiring treatment with intubation and mechanical ventilation in the 5 years prior to study entry Hyposensitization therapy other than an established maintenance regimen Inability to coordinate use of the delivery devices used in the study, based on the opinion of the investigator or clinical coordinator Pregnant
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1
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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.
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eligible ages (years): 4.0-17.0, Asthma English speaking participants aged 4-17 years from four rural schools with physician diagnosed asthma or symptoms of asthma in the previous 12 months (coughing, wheezing, chest tightness, shortness of breath) (per parental or legal guardian report) and current taking prescribed medications for asthma such as inhalers, syrup or breathing machine Children with significant underlying respiratory disease other than asthma (such as cystic fibrosis) or significant co-morbid conditions such as severe developmental delay or cerebral palsy will be excluded from the study
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1
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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.
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eligible ages (years): 18.0-999.0, Asthma Pulmonary Disease, Chronic Obstructive No change from the MIA and LEUKO trials No change from the MIA and LEUKO trials
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0
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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.
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eligible ages (years): 18.0-50.0, Asthma A. Subjects with Allergic Asthma (AA subjects) 1. All subjects will have a baseline FEV1 determined at the characterization visit that is no less than 75 % of the predicted value. 2. All subjects will have a clinical history of allergic symptoms to cat or dust mite allergen and demonstrated skin reactivity (a positive allergen prick test). 3. Life-long absence of cigarette smoking (defined as a lifetime total of less than 5 pack-years); none in 5 years). 4. Willing and able to give informed consent. 5. Expressed the desire to participate in an interview with the principal investigator. 6. Age between 18 and 50 years Women of childbearing potential who are documented to be pregnant (based on Urine beta-HCG testing), are sexually active and not using contraception, are seeking to become pregnant, or who are nursing. 2. The presence of spontaneous asthmatic episode or clinical evidence of upper respiratory tract infection within the previous 6 weeks. 3. Participation in research study involving a drug or biologic during the 30 days prior to the study. 4. Intolerance to albuterol, atropine, lidocaine, fentanyl, or midazolam. 5. Antihistamines within 7 days of the screening visit. 6. Presence of diabetes mellitus, congestive heart failure, ventricular arrhythmias, history of a cerebrovascular accident, renal failure, history of anaphylaxis, or cirrhosis. 7. Use of systemic steroids, increased use of inhaled steroids, beta blockers and MAO inhibitors or a visit for an asthma exacerbation within 1 month of the screening visit. 8. Antibiotic use for respiratory disease within 1 month of the characterization visit or a respiratory tract infection within 6 weeks of the bronchoscopy visits. 9. A history of asthma-related respiratory failure requiring intubation. 10. Quantitative skin-prick test positive reaction down to an allergen concentration of 0.056 BAU or AU/ml . 11. Taking beta-adrenergic blocking agents or monoamine oxidase inhibitors. 12. Subjects with a high possibility of poor compliance with the study. 13. No history of cigarette smoking within the past 5 years or > 10 pack years total. 14. Having second-hand cigarette smoke exposure or indoor furry pets except in the case of dog, if the subject is not allergic to the dog and the subject has a negative skin test to dog (It is also preferred but not required that dust mite allergic subjects have dust mite-proof encasings on their mattress and pillows.) 15. Other lung diseases, such as sarcoidosis, bronchiectasis or active lung infection. 16. Use of Xolair (omalizumab anti-IgE monoclonal antibody) for 6 months. 17. Immunotherapy with cat or dust mite extract now or in the past. 18. Non-English speakers. 19. History of coagulopathy, thrombocytopenia, pulmonary hypertension, and/or use of anti-coagulants/anti-platelet drugs. B. Healthy Normal Control Subjects (NC subjects) Normal control subjects will be individuals who are in good overall health, age and sex matched to the asthmatic group, age 18 and nonallergic, i.e. entirely negative on the panel of prick skin tests listed in section V (Study Procedures), with no history of allergic rhinitis or asthma, no history of allergic symptoms caused by cats or dust mite allergen exposure, life-long nonsmokers of cigarettes (defined as a lifetime total of less than 5 pack-years and none in 5 years), normal spirometry (i.e. FEV1 and FVC of at least 90% of predicted) and with a methacholine PC20 of > 16 mg/ml A history of allergy, asthma, nasal or sinus disease. 2 #1, 3-8 and 10-19 from (A.) above. C. Allergic Nonasthmatic Subjects (ANA subjects) 1. ANA subjects will have a history of either (a) allergic rhinitis (with one or more of the following symptoms: nasal congestion, sneezing, runny nose, postnasal drainage), (b) allergic conjunctivitis (ocular itching, tearing and/or swelling) or (c) contact allergy associated with cat dander or dust mite and a positive allergy test to the same allergen. 2. All subjects will have a baseline FEV1 and FVC determined at the characterization visit that is no less than 90 % of the predicted value. 3. All subjects will have a positive allergy skin prick test to cat dander or dust mite allergen. 4. All subjects will be in good general health. 5. Life-long absence of cigarette smoking (defined as a lifetime total of less than 5 pack-years and none in 5 years). 6. Willing and able to give informed consent. 7. Expressed the desire to participate in an interview with the principal investigator. 8. Age between 18 and 50 years A history of asthma. 2 #1, 3-8 and 10-19 from (A.) above. 3. A methacholine PC20 < 16 mg/ml
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1
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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.
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eligible ages (years): 18.0-65.0, Anxiety/Depression in Cardiological Unit investigated for chest pain or palpitation 6 month ago at Cardiological Out-patient Clinic, Molde Hospital suffer of chest pain or palpitations do not speak norwegian properly mentally retarded psychosis last 6 month current alcohol or drug misuse
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0
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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.
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eligible ages (years): 18.0-55.0, Asthma Patient has a history of mild to moderate persistent allergic asthma for at least 6 months with typical symptoms, including cough, wheezing, and shortness of breath, is clinically stable and has no history of recent respiratory tract infection within 3 weeks of the start of the study Patient, aside history of asthma, is judged to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests Patient is able to perform reproducible pulmonary function test Patient has an allergic response to house dust mite allergen, demonstrates a positive early and late phase response to an inhaled allergen challenge (as defined by a bronchoconstrictive response) Patient is a nonsmoker for at least 12 months. Patients must have less than or equal to 10 pack years of smoking to be included. (10 pack years = one pack per day for 10 years.) Patients who have discontinued smoking for at least 10 months may be enrolled at the discretion of the investigator Patient is willing to avoid strenuous physical activity (i.e., strenuous or unaccustomed weight lifting, running, bicycling, etc.) for 72 hours prior to each visit when laboratory safety tests are obtained and 48 hours prior to allergen challenge Patient has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses additional risk to the patient by their participation in the study Patient has taken oral corticosteroids within 8 weeks or inhaled corticosteroids/nasal corticosteroids within 4 weeks of screening and/or during the study Patient has a history of stroke, chronic seizures, or major neurological disorder Patient has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory (other than asthma), or genitourinary abnormalities or diseases, or has a history of neoplastic disease Patient is unable to refrain from or anticipates the use of any medication other than the ones permitted in this study, including prescription and non-prescription drugs or herbal remedies prior to administration of the initial dose of study drug, throughout the study (including washout intervals between treatment periods), until the poststudy visit Patient consumes excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages per day or >21 drink equivalents per week Patient consumes excessive amounts, defined as greater than 6 servings of coffee, tea, cola, or other caffeinated beverages per day
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1
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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.
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eligible ages (years): 20.0-60.0, Asthma Healthy male adults aged between 20 and 60 years inclusive Healthy as determined by a responsible physician, based on a medical evaluation including 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 considers that the finding will not introduce additional risk factors and will not interfere with the study procedures Male subjects must use double-barrier (condom/spermicide) birth control methods or abstain from sexual intercourse with female partners who are pregnant, lactating, or able to bear children in addition to any birth control method the female partner is using, from the first dose of study medication until 90 days after the last dose of study medication Japanese ethnic origin (defined as having been born in Japan with four ethnic Japanese grandparents and able to speak Japanese) Body weight ≥ 45 kg and body mass index within the range of 18-28 kg/m2 inclusive No significant abnormality on 12-lead ECG at screening, including the following specific requirements Ventricular rate ≥ 45 beats per minute PR interval ≤ 210msec Q waves < 30msec (up to 50 ms permitted in lead III only) QRS interval to be ≥ 60msec and ≤ 120msec As a result of medical interview, physical examination or screening investigations, the principle investigator or delegate physician deems the subject unsuitable for the study. Subjects must not have a systolic blood pressure above 145 mmHg or a diastolic pressure above 85 mmHg unless the Investigator confirms that it is satisfactory for their age The subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness Subjects who have suffered an upper or lower respiratory tract infection within 4 weeks of the screening visit Liver function tests (AST, ALT or ALP) greater than 1.5 of the upper limit of laboratory reference range History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation History of milk protein allergy The subject has taken prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is the longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Sponsor the medication will not interfere with the study procedures or compromise subject safety The subject has taken oral corticosteroids less than 8 weeks before the screening visit The subject has taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit History of alcohol/drug abuse or dependence within 12 months of the study
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1
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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.
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eligible ages (years): 0.0-999.0, Cystic Fibrosis Infection Pseudomonas Aeruginosa Clinical diagnosis of cystic fibrosis Colonized with Pseudomonas aeruginosa informed consent Egg allergy
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0
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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.
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eligible ages (years): 18.0-75.0, Asthma Patients will be between 18 and 75 years of age, male or female, with a diagnosis of asthma for at least one year. Oxygen saturation on room air greater than or equal to 92 percent Diagnosis of a pulmonary disorder other than asthma (for example: chronic bronchitis, emphysema, cystic fibrosis, bronchiectasis, sarcoidosis, HIV-related lymphocytic airway inflammation). Cigarette smoking within the past 3 months or a prior history of greater than 10 cumulative pack-years. History of coronary artery disease. Research volunteers will be between 18 and 75 years of age, male or female. Oxygen saturation on room air greater than or equal to 92 percent Same as the asthmatic plus a history of asthma. Reversible Airflow Obstruction (increase in FEV (1) by 12 percent and 200 cc after inhaled beta 2-agonist)
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2
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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.
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eligible ages (years): 18.0-999.0, Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus Moderate Chronic Obstructive Pulmonary Disease Asthma Asthma Physician diagnosis of asthma with history of any or all of the following: recurrent wheezing, recurrent chest tightness, recurrent difficulty breathing, or cough, particularly worse at nighttime Never smoked or former smokers (= 6 months since cessation) ≥18 years of age Prebronchodilator Forced Expiratory Volume in 1sec (FEV1) ≥ 60% Third National Health and Nutrition Examination Survey (NHANES III) predicted, prebronchodilator total lung capacity (TLC) ≥ 80% predicted Intermountain Thoracic Society (ITS), and prebronchodilator single breath carbon monoxide diffusing capacity of the lung (DLco) (unc) ≥70% predicted (Miller) < 30% day-to-day variability in daily morning Peak expiratory Volume (PEF) during the 2-week run-in period Significant improvement in pre to postbronchodilator spirometry (defined as an increase from baseline of ≥ 12% and ≥ 200 mL in FEV1 or Forced Vital Capacity [FVC]) at Screening/Visit 1 or documented significant improvement in pre to postbronchodilator spirometry (as defined above) within past 12 months in subject's medical records or a documented positive methacholine challenge test within the past 12 months COPD Physician diagnosis of COPD (including emphysema and/or chronic bronchitis), history of dyspnea and/or intermittent or daily chronic cough with or without sputum production, not attributable to any other known cause History of pulmonary exacerbation within 8 weeks of screening/V1 or between V1 and V2 Use of systemic corticosteroids or antibiotics for respiratory illness within 8 weeks of screening/V1 OR between V1 and V2 Increase from baseline in the use of short-acting bronchodilator or short-acting anticholinergic agents, or the combination of the 2, by ≥6 puffs or ≥3 nebulizer treatments per day for ≥ 2 days Treatment with supplemental oxygen therapy, room air oxygen saturation, 94% or history of intubation or ICU admission for respiratory illness in the past 5 yrs Greater than 2 hospitalizations or ER or urgent care visits or required >3 courses of systemic steroid in the past 12 months for respiratory illness Use of Symlin® (pramlintide acetate) within the preceding 90 days Two or more severe hypoglycemic episodes within 6 months of screening or episode of severe hypoglycemia between Screening and Baseline Previous exposure to any inhaled insulin product Currently using an insulin delivery pump Requires significant change (define as initiation of a new medication or change in the dose or frequency of the controller medications) in the asthma or COPD therapeutic regimen within 8 weeks of Screening/Visit 1 (Week -4) or between Visit 1 and Baseline/Visit 2
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1
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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.
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eligible ages (years): 18.0-65.0, Coronary Artery Disease Chest Pain Patients given clopidogrel loading dose before scheduled catheterization or percutaneous intervention Acute coronary syndrome Unable to tolerate clopidogrel
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0
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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.
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eligible ages (years): 50.0-999.0, Heart Failure, Congestive Stage C Heart Failure,[34] which refers to past or current symptoms of heart failure with underlying structural heart disease. Indicated by chronic systolic dysfunction (left ventricle [LV] ejection fraction < 45%), diastolic dysfunction (with echo evidence of diminished compliance of the LV), or both. 2. The patient's cardiologist has recommended or initiated one of the following to prevent decompensation: continuing diuretic treatment, fluid restrictions, and/or restriction/reduction of dietary sodium intake. 3. A family member or members available for study participation with whom patient lives for at least 5 days a week. Emphasis will be given to the closest family members available (i.e., spouse). 4. Subjects are able to give informed consent (see below for due to well-documented dementia or evidence of cognitive impairment). 5. Patients will be age 50 or above. Younger patients may have a different family environment than the most common type of patient who is the target of the FPI intervention Patient has a well-documented diagnosis of dementia 2. Moderate or greater cognitive impairment, based on the Blessed Test of Orientation, Memory, and Concentration (BOMC)[26] score of 16. 3. Patient's family member has BOMC score of 10 (i.e., mild or greater cognitive impairment). 4. Inability to communicate verbally, major visual impairment, uncorrected hearing loss. 5. Patient and/or family member reports "frequent use" illicit substance abuse within the past year. Scores on the AUDIT-C 4 indicating alcohol abuse/dependence.[30] 6. Patient or family member has a current diagnosis of schizophrenia spectrum psychiatric disorder (e.g., schizophrenia, schizoaffective disorder). 7. Patient indicates active suicidal ideation and evaluated as a clinical risk. 8. Patient is in the Philadelphia VAMC home-telehealth program or some other incompatible intervention. 9. Patient has an unstable medical condition that would likely prevent the subject from completing the study
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0
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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.
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eligible ages (years): 12.0-999.0, Asthma Diagnosis of asthma and baseline lung function tests, symptoms and medication use as determined by the protocol Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol Has required treatment with non-inhaled corticosteroids within previous 30 days, has sensitivity to drugs specified in the protocol or requires treatment with a beta-blocker Has had cancer within previous 5 years or has a condition that may put the patient at risk in this study
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1
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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.
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eligible ages (years): 18.0-65.0, Asthma Age 18-65 at the Screening Visit History of asthma for at least 6 months prior to Screening Visit Well controlled asthma with rescue short acting beta agonist (albuterol) and or stable doses of other medications for at least 4 weeks prior to Screening Visit Female subjects that are not pregnant or lactating Otherwise healthy as determined by the Investigator Life-threatening asthma within the past year or visit to emergency room for asthma in the past 3 months prior to the Screening Visit Significant,nonreversible pulmonary disease (e.g. chronic obstructive pulmonary disease, cystic fibrosis or bronchiectasis) Use of any steroid medications, topical or inhaled steroids within 4 weeks or systemic (oral or injectable) steroids within 3 months of dosing An upper or lower respiratory tract infection within the last 4 weeks pior to Screening Visit or acute illness or infection within 6 weeks prior to dosing Any significant disease or major disorder that may jeopardize subject safety History of tabacco use within 6 months prior to dosing and/or smoking history > 10 pack-years Female subjects on hormone replacement therapy or using birth control involving hormones in the past 6 months Additional and will evaluated by the investigator
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1
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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.
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eligible ages (years): 18.0-70.0, Asthma for severe asthmatics Physician diagnosis of asthma Aged 18 Non-smokers or ex-smokers with less than 5 pack/year history Major characteristics (at least one of the following criteria) Treatment with continuous or near continuous (>50% of year) oral corticosteroids Requirement for treatment with high dose inhaled corticosteroids (ICS) Minor characteristics (at least 2 out of the following) 1. Requirement for daily treatment with a controller medication in addition to ICS e.g. LABA, theophylline, leukotriene antagonist 2. Asthma symptoms requiring SABA on a daily or near daily basis 3. Persistent airways obstruction (FEV1 <80% predicted, diurnal PEF variation >20%) 4. One or more emergency care visits for asthma per year 5. 3 or more steroid "bursts" per year 6. Prompt deterioration with ≤ 25% reduction in oral or ICS 7. Near fatal asthma event in the past for moderately-severe asthma Physician diagnosis of asthma Current smokers, or less than 3 years since quitting smoking Less than 4 weeks from an exacerbation Diabetes Active peptic ulceration Previous history of psychiatric disturbances on high dose prednisolone On steroid-sparing agent or immunosuppressant such as azathioprine, methotrexate and ciclosporin Concomitant anti-IgE therapy Pregnancy
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2
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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.
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eligible ages (years): 18.0-999.0, Chest Pain Coronary Artery Disease Patients referred to Kettering Medical Center for PET myocardial perfusion imaging with or without CTA and/or coronary flow reserve measurement Patients over 18 years of age Patients who do not consent to participate
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0
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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.
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eligible ages (years): 18.0-70.0, Asthma Diagnosed persistent asthma regular use of inhaled steroids and concomitant medication never been diagnosed COPD seasonal asthma
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2
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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.
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eligible ages (years): 12.0-999.0, Asthma Willingness to participate and comply with procedures by signing a written informed consent years of age or older of either gender and any race Women of childbearing potential (includes women who are less than 1 year postmenopausal and currently are or will become sexually active during the study) must be using or agree to use an acceptable method of birth control unless they are surgically sterilized Must understand and be able to adhere to dosing and visit schedules, and agree to record symptom severity scores, PEFR values, medication times, and concomitant medications accurately and consistently in a daily diary Diagnosed history of mild-moderate persistent asthma for at least 12 months FEV1 must be >60% of predicted normal or personal best FEV1 during the last 12 months Using daily inhaled corticosteroids for at least 30 days prior to Screening. In the Screening Visit patients FEV1 should be >= 65% to <= 90% predicted Asthma Symptom Total daily (AM+PM) severity score at Screening Visit should be <= 2 For two weeks prior to Screening, subjects must have been on a stable regimen of one of the following twice daily regimen: fluticasone propionate (FP) >= 100 <= 500 mcg/day; budesonide (BUD) >= 200 Females who are pregnant or breast-feeding Subjects who have not observed the designated washout periods for any of the prohibited medications Subjects who have used any investigational product within 30 days or any antibodies for asthma or allergic rhinitis in the past 90 days prior to enrollment Subjects who have any clinically significant deviation from normal in the physical examination that may interfere with the study evaluations or affect subject safety Subjects who have required systemic steroids within the previous month Subjects who are allergic or have an idiosyncratic reaction to corticosteroids Subjects who have required inpatient hospitalization for asthma control within the previous 3 months, or more than once in the previous 6 months Subjects with clinical evidence of chronic obstructive pulmonary disease or lung diseases other than asthma Subjects who have experienced an upper or lower respiratory tract infection within the previous 2 weeks prior to the Screening Visit Subjects with evidence of clinically significant oropharyngeal candidiasis
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1
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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.
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eligible ages (years): 18.0-65.0, Asthma Man or woman 18 to 65 years of age of any race Has mild, stable, allergic asthma as defined by American Thoracic Society criteria Has history of episodic wheezing and shortness of breath Has Forced Expiratory Volume in 1 second (FEV1) of at least 70% of predicted at Screening and within 10% of preallergen screening value at both baselines Has positive methacholine challenge at Screening. Methacholine challenges are considered positive if decreases of at least 20% in the FEV1 occur at a concentration of less than or equal to 16 mg/mL Baseline methacholine PC20 (concentration that initiated a 20% fall in FEV1) must be within 1 doubling concentration of the preallergen screening PC20 to enter treatment Has positive skin-prick test to common allergens (cat, dust mite, grass, pollen) Has a positive Early Asthmatic Response of >=20% fall in FEV1 measured from the FEV1 immediately prior to challenge, and Late Asthmatic Response of >=15% fall in FEV1 from the FEV1 measured immediately prior to challenge during Screening period Has been free from asthma exacerbation for at least 4 weeks before Screening. An exacerbation is defined as an occurrence of any clinical deterioration of asthma that requires emergency treatment, hospitalization due to asthma, or treatment with additional medication, as judged by the clinical investigator Has been free from relevant seasonal allergen exposure for at least 4 weeks before the study and be able to remain so for the duration of the study Has had a diagnosis of chronic obstructive pulmonary disease (COPD) or any other clinically relevant lung disease (eg, cystic fibrosis, pulmonary fibrosis, bronchiectasis) other than mild allergic asthma, or has a history of having been intubated Has had a worsening of a respiratory tract infection within 4 weeks before Screening Has had any clinically significant abnormality; history of clinically significant hypotensive episodes of fainting, dizziness, or lightheadedness; history or symptoms of cardiovascular disease; significant neurologic disease; or hematologic abnormality, including coagulopathy; or has a medication regimen or clinically relevant medical condition other than asthma that may interfere with the effect of study medication Had a peripheral blood neutrophil (PBN) count of <3 × 10^9/L at the Screening Visit Has an allergy/sensitivity to the study drug or its excipients Is pregnant, breast-feeding, or intends to become pregnant during the study Has used any investigational drug within 30 days or 5 half-lives of Screening Is presently participating in any other clinical study Is part of the staff personnel directly involved with this study Is a family member of the investigational study staff
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1
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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.
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eligible ages (years): 12.0-69.0, Asthma Asthmatic participants Males or females greater than or equal to 12 and less than 70 years of age Physician-diagnosed and investigator-confirmed stable asthma (excluding exercise induced asthma) Current treatment for asthma by a healthcare provider within the preceding twelve months: current asthma treatment defined as regular use of asthma medications. Asthma medications short and long acting adrenergic bronchodilators, bronchodilator combinations, inhaled anticholinergics, inhaled corticosteroids, cromolyn sodium and nedocromil, leukotriene modifiers and methylxanthines Stable asthma defined by no asthma exacerbation (emergency room visit, hospitalization, course of increased systemic steroids, or urgent health care visit for asthma) during the prior four weeks Forced expiratory volume at one second (FEV1) >70% predicted pre-bronchodilator Ability to provide screening and baseline information Ability and willingness to provide informed consent For women of childbearing potential: not pregnant, non-lactating, and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study Chronic oral steroid therapy (daily) Oral corticosteroid use within past 4 weeks Respiratory tract infection within past 4 weeks Chronic diseases (other than asthma) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation, e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, or nervous system, or immunodeficiency Known allergy to methacholine (for example, a previous bad reaction to methacholine) or to any other parasympathomimetic agents Current use of beta adrenergic blocking agent (a heart medicine) or a cholinesterase inhibitor (medicine used to treat myasthenia gravis or Alzheimer's disease) History of epilepsy, cardiovascular disease with bradycardia (slow heart beat), vagotonia (increased activity of the vagus nerve causing slow heart rate or low blood pressure), peptic ulcer disease, thyroid disease, or urinary tract obstruction History of cigarette smoking within the past 5 years or >10 pack years total Use of investigative drugs or intervention trials in the 30 days prior to enrollment or during the duration of the study Any condition or compliance issue which in the opinion of the investigator might interfere with participation Nonasthmatic control
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1
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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.
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eligible ages (years): 18.0-75.0, Asthma Clinical history consistent with asthma Has a current prescription for a long-acting beta agonist, either along or in combination with an inhaled corticosteroid (salmeterol, formoterol, fluticasone/salmeterol, or budesonide/formoterol) Ability to provide informed consent Non-smoker (total lifetime smoking history < 10 pack-years; no more than five occasions of smoking any substance or using smokeless tobacco products in the past year) No smoking or use of smokeless tobacco in the past 30 days No known contraindication to inhaled tiotropium e.g. narrow angle glaucoma, history of bladder neck obstruction or significant symptoms related to prostatic hypertrophy Lung disease other than asthma Established or suspected diagnosis of vocal cord dysfunction Significant medical illness (other than asthma) that is not stable History of life-threatening asthma requiring treatment with intubation and mechanical ventilation within the past 5 years History of respiratory tract infection within the previous 4 weeks (only applies at screening visits) Hyposensitization therapy other than an established maintenance regimen Allergy to tiotropium Pregnancy or lactation. If potentially able to bear children, not using an acceptable form of birth control Inability to use inhaler devices Inability to participate over the one year period
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2
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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.
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eligible ages (years): 12.0-999.0, Allergic Asthma Allergic Rhinitis Allergic asthma or allergic rhinitis age 12+ smokers
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2
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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.
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eligible ages (years): 1.0-45.0, Respiratory Sounds Patient and/or parents/guardian signed informed consent Patients with cough or shortness of breath Chest tubes Skin lesions precluding attachment of sensors Respiratory distress Pregnant women
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2
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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.
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eligible ages (years): 18.0-999.0, Allergic Asthma Age > 18 years, a physician's diagnosis of allergic asthma A documented sensitization to aero-allergens (pollen, animal hair, or house dust mite) A pre-bronchodilator forced expiratory volume in the first second (FEV1) > 80 % of the predicted value (% predicted), a provocative concentration of histamine causing a 20 % fall in FEV1 (PC20) of < 8 mg histamine / ml No regular treatment (only short-acting inhalers on demand were allowed) No history of or evidence for any other chronic disease than asthma No history of smoking, absence of any signs or symptoms of an infection
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1
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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.
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eligible ages (years): 12.0-999.0, Asthma Key Clinical diagnosis of Asthma Reversibility ≥ 12% and ≥200mls reversibility of FEV1 within approximately 30-minutes following 2 to 4 puffs of albuterol FEV1 between 40-85% predicted Currently on short acting beta2 agonist therapy Key History of life threatening asthma Respiratory Infection or oropharyngeal candidiasis Asthma exacerbation Uncontrolled disease or clinical abnormality Allergies Taking another Investigational medications or other prohibited medications
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1
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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.
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eligible ages (years): 18.0-65.0, Asthma Male or female aged 18 to 65 years, inclusive History of moderate to severe asthma: Currently on a medium to high dose of an inhaled corticosteroid (ICS)and long-acting bronchodilator, and/or for medium dose of ICS as per GINA guidelines. ICS requirements are as follows: Beclomethasone HFA 80* - 4 puffs/day; Budesonide DPI 180* puffs/day; Budesonide/Fomoterol MDI* puffs/day; Ciclesonide 80* puffs/day; Ciclesonide 160* puffs/day; Flunisolide CFC 250* puffs/day; Fluticasone 110* puffs/day; Fluticasone 220* puffs/day; Fluticasone/salmeterol DPI 250/50 puffs/day; Fluticasone/salmeterol MDI 115/21 The use of the following medications will subjects from entering the study: Oral or parenteral steroids months; Omalizumab less than 12 months; Short and long-acting anticholinergics Stop at time of run-in; Antileukotrienes, beta-adrenergic blocking agents, inhaled cromolyn sodium or nedocromil, macrolide antibiotics Stop at time of run-in Tobacco within 1 year or >5 pack years Pregnant women, lactating women, or women of childbearing age not willing to take precautions to avoid becoming pregnant during the study Subjects with upper respiratory infection or receiving an influenza vaccine within 6 weeks before the study Subjects with a history of allergy or adverse reaction to inhaled beta2-agonists, methacholine, salmeterol, fluticasone, epinephrine or omalizumab or related classes of drug(s) Subjects with clinically significant evidence of cardiovascular, central nervous system, endocrine, gastrointestinal, hematopoietic, hepatic, renal, psychiatric, respiratory (other than asthma) disease, or any other severe medical condition(s) that in the view of the investigator prohibits participation in the study
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1
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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.
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eligible ages (years): 12.0-80.0, Asthma Ages 12-80 years. [NOTE: Only the Johns Hopkins site will enroll subjects under 18.] Clinical history consistent with asthma (GINA 4 definitions) for at least six months Current symptoms and features of partly-controlled or uncontrolled asthma, according to GINA classification of asthma control A stable (1 month) treatment regimen consisting of as needed short-acting bronchodilators alone as needed short-acting bronchodilators in combination with low or medium-dose inhaled corticosteroids (<= 1000 mcg per day beclomethasone or equivalent any combination of long acting beta-agonist bronchodilator and low or medium-dose inhaled corticosteroid (as defined above),as needed short-acting bronchodilators in combination with montelukast or other leukotriene modifier Willingness to comply with the study protocol and ability to perform the study procedures Pulmonary disease other than asthma, such as smoking-related chronic obstructive pulmonary disease (COPD), clinically significant bronchiectasis, lung resection, and interstitial lung disease Other significant systemic illness which might, in the opinion of the investigator alter the risk or outcome of the study (e.g. cardiovascular arrhythmias or conduction abnormalities, hyperthyroidism, uncontrolled hypertension, cancer) Tobacco smoking greater than 10 pack-year of cumulative exposure or current smoking within 10 years Respiratory tract infection within 6 weeks of the study Seasonal allergies causing symptoms within the past 4 weeks. Perennial or out of season allergic rhinitis is acceptable. Nasal corticosteroids and long-acting antihistamines are acceptable Any investigational drug or treatment within 30 days Use of cromolyn, nedocromil, theophylline, tiotropium, or oral albuterol within 1 week prior to Visit 1 of the study Current use of omalizumab or within the last 8 weeks Subjects on anti-depressant (mono-amine oxidase inhibitors or tricyclic antidepressants) treatment within 8 weeks Non-potassium sparing diuretics unless in fixed combination with potassium-sparing diuretics within one week
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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.
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eligible ages (years): 0.0-999.0, Atopic Dermatitis Patient has participated in the FG-506-06-21 study in Helsinki Patient was tested for bronchial hyperreactivity in the years 1998-2000 Patient gives signed informed consent to participate in this study
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0
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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.
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eligible ages (years): 18.0-999.0, Asthma Male or female patient, ≥ 18 years of age with a documented clinical history of asthma, has been treated for asthma and, in the opinion of the Investigator, is not fully controlled on current asthma therapy. 2. Patient satisfies, or has satisfied in the past, the GINA definition of moderate persistent to severe persistent asthma. 3. Patient has been maintained on moderate-to-high doses of ICS and LABA in the form of combination therapy or as individual agents (equivalent to fluticasone ≥ 250 mcg bid and salmeterol ≥ 50 mcg bid for ≥ 4 weeks before Screening [Visit 1]). 4. Patient has experienced an asthma exacerbation at least once in the past 2 years (defined here as use of physician prescribed oral corticosteroids or asthma requiring treatment increase approximately 4 times the baseline dose of inhaled corticosteroids or hospitalization due to asthma). 5. Patient has a pre-bronchodilator FEV1 ≥ 50% but ≤ 95% of the predicted value at both Screening (Visit 1) and Visit 2. 6. Patient demonstrates ≥ 12% reversibility (and a ≥ 200 mL difference) from prebronchodilator FEV1 within 15 to 30 minutes of receiving up to 4 puffs of a short-acting beta-agonist at Screening (Visit 1) or has ≥ 10% reversibility from pre-bronchodilator FEV1 plus a documented reversibility of ≥ 12% within the previous 12 months (documented methacholine or histamine sensitivity (PC20) <8mg/mL is also acceptable evidence or reversible airways disease). 7. Patient scores ≤ 20 on The Asthma Control Test™ at Screening (Visit 1) and Visit 2. 8. Female patient of childbearing potential or male patient and his female partner are practicing adequate and effective forms of contraception and agree to continue for the duration of the study. If female, must have a negative urine pregnancy test. 9. Patient has a pre-study medical history, physical examination, 12-Lead ECG, and safety laboratory test results within normal reference ranges or clinically acceptable to the Investigator. 10. Patient is a non-smoker for at least 6 months before Screening (Visit 1) and has a < 10 pack/year history of smoking. 11. Patient is medically stable for at least 8 weeks before Randomization (Visit 2), and the Investigator does not consider study participation to place the patient at increased risk of AEs (with the exception of possible asthma exacerbations). 12. Patient is able and willing to give written informed consent Patient has a current diagnosis of respiratory disorder other than asthma (e.g., chronic bronchitis, bronchiectasis, emphysema, chronic obstructive pulmonary disease [COPD], etc). 2. Patient has received oral corticosteroid treatment within 8 weeks of Randomization (Visit 2)or patient has been intubated for ventilation in the past 5 years. 3. Patient has used any leukotriene antagonist within 1 week before Screening (Visit 1) or anti-IgE medications within 4 weeks of Screening (Visit 1). 4. Female patient is pregnant, breastfeeding, or not using an adequate method of contraception. 5. Patient has a clinically relevant medical history of very severs asthma that would preclude steroid reduction or sufficient compliance with the protocol. 6. Patient uses concomitant medications, including herbal, over-the-counter, or prescription medicines that, in the opinion of the Investigator, may affect the outcome of study endpoints and/or well-being of the patient. 7. Patient has a history of alcohol or substance abuse within 2 years of Screening (Visit 1). 8. Patient consumes more than 28 units (male) or 21 units (female) of alcohol a week (unit = 1 glass of wine = 1measure of spirits = ½ pint or 8 fluid ounces of beer). 9. Patient cannot communicate reliably with the Investigator or is unlikely to cooperate with the requirements of the study. 10. Patient has previously taken or another formulation of AER 001 (e.g., BAY 16-9996, pitrakinra). 11. Patient has participated in any clinical trial involving use of an investigational drug within 12 weeks of first dose of study drug
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2
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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.
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eligible ages (years): 18.0-50.0, Asthma Males or females age 18 to 50 yrs History of asthma based upon presence of asthma symptoms such as cough, shortness of breath, wheeze or chest tightness positive skin-prick test to a House Dust Mite extract Forced expiratory volume at one second >70% predicted pre-albuterol, > 80% predicted post albuterol >12% increase in Forced expiratory volume at one second following inhaled albuterol (180 µg) and/or airway responsiveness to methacholine (PC20 <8mg/ml) > 20% immediate drop in FEV1 following inhaled antigen challenge Safety laboratory assessments within normal ranges (labs to complete blood count with differential, blood urea nitrogen, creatinine, aspartate aminotransferase, alanine aminotransferase, Prothrombin time, Partial Thromboplastin Time, and platelet count) Female subjects of child-bearing potential must have a negative urine pregnancy test (urine HCG) within 48 hours of the methacholine challenge at Visit 2 and agree to use a reliable method of birth control for the duration of the study (reliable methods of birth control can abstinence, barrier methods, oral contraceptives, injection contraceptives or skin absorption contraceptives) In the opinion of the investigator, capable and willing to grant written informed consent and cooperate with study procedures and requirements Use of inhaled or systemic corticosteroids or leukotriene inhibitors within 1 month of screening Treatment with Omalizumab (anti-IgE) within 9 months of screening visit Concomitant use of any other monoclonal antibody Respiratory infection within 4 weeks of study Unstable asthma as indicated by self-report of increased symptoms or increased beta-agonist use over the previous 2 weeks Female subjects who are pregnant, nursing or have a pregnancy planned during the course of study Current smokers (defined as smoked within the last year) or a former smoker with a history of >5 pack years Major health problems such as heart disease, type I and II diabetes or lung diseases other than asthma. Decisions regarding this will be based upon the judgment of the investigator Previous malignancy Medication other than for asthma, allergies or contraception and that the investigator feels may interfere with the conduct of study (e.g. monoamine oxidase inhibitors and B-adrenergic antagonists in any form)
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1
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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.
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eligible ages (years): 6.0-12.0, Rhinitis, Allergic, Seasonal Asthma Children must be >= 6 to < 12 years of age of either sex and any race Children's parent(s) or legal representative(s) must demonstrate their willingness to participate in the study and comply with its procedures by signing an informed consent Children must be free of any clinically significant disease (other than SAR) that would interfere with study evaluations Children's parent(s) or legal representative(s) must understand and be able to adhere to dosing and visit schedules, agree to report concomitant medications and adverse events to the Investigator or designee The diagnosis of seasonal allergic rhinitis with or without intermittent asthma will be assessed by Clinical history of sneezing, rhinorrhea (nasal discharge/running nose or post-nasal drip), nasal stuffiness/congestion and nasal itching and non-nasal symptoms (eye symptoms) as itching, burning, tearing and redness, during the previous pollen season Ascertained skin prick positivity (or RAST positivity) to one of the following: grasses, parietaria, birch, hazelnut (the skin test has to be performed within the last year) Children must be clinically symptomatic with SAR at Visit 1 (day 1): the total (nasal + non nasal) symptoms score must be >= 8 with a nasal congestion score of >= 2, and the non-nasal symptoms severity score must be >= 2 Asthma symptoms (wheezing, cough, difficulty breathing, chest tightness) will be evaluated at visit 1 (day 1) and graded only for child with concomitant asthma Children who have not observed the designated washout periods for any of the prohibited medications Children with persistent asthma (mild, moderate or severe) or perennial allergic rhinitis (PAR) Children with rhinitis medicamentosa Children who have had an upper respiratory tract or sinus infection that required antibiotic therapy within 14 days prior to Visit 1 (day 1), or children who have had a viral upper respiratory infection within 7 days prior to Visit 1 (day 1) Children who have nasal structural abnormalities, including nasal polyps and marked septal deviation, that significantly interfere with nasal airflow Children who, in the opinion of the Investigator, are dependent upon nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids Children with a history of hypersensitivity to desloratadine or any of its excipients Children who have any current clinically significant metabolic, cardiovascular, hepatic, renal, immunologic, neurologic, hematologic, gastrointestinal, cerebrovascular or respiratory disease, or any other disorder which, in the judgment of the Investigator, may interfere with the study evaluations or affect subject safety A known lack of response to H1-antihistamines
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1
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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.
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eligible ages (years): 15.0-70.0, Asthma Patient is male or female, at least 15 years of age and no more than 70 years Patient has mild persistent asthma (step 2) of the Guidelines for the Diagnosis and Management of Asthma issued by the National Heart, Lung, and Blood Institute of the National Institutes of Health as defined by a history of symptoms at least once a week but less than daily (step 2) (5) Current asthma treatment includes short-acting inhaled β-agonist alone as needed Patient fulfils all the following signs and symptoms of asthma History of symptoms including, but not limited to dyspnea, wheezing, chest tightness, cough, or sputum production for at least 12 months A forced expiratory volume in one second (FEV1) of at least 80% of the predicted value (pre-bronchodilator) while withholding β-agonist for at least six hours Patient has a diagnosis of asthma as defined by 1) an increase in FEV1 or PEF of ≥12% (absolute value), 20 to 30 minutes after inhaled β-agonist administration, OR 2) a positive methacholine PC20 (provocative concentration causing a 20% fall in FEV1) of 8 mg/ml or lower which was performed within the previous 12 months, OR 3) a fall in FEV1 of at least 15% after an exercise challenge which was performed within the previous 12 months. β-agonist reversibility and the methacholine and exercise challenge tests may be satisfied within the previous 12 months if there is adequate source documentation Patients demonstrate symptoms requiring β-agonist use on ≥2 and ≤6 days of the week for the previous two weeks Patient is able to chew a tablet Patient is judged to be in good, stable physical and mental health (except for his/her asthma) based on the medical history, physical examination, and routine laboratory data, and appears able to successfully complete this trial none
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1
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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.
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eligible ages (years): 18.0-65.0, Asthma Men and women 18 to 65 years of age Generally good health; steroid naïve (or who have not taken inhaled/oral corticosteroid within last month) mild to moderate, stable, allergic asthma as defined by ATS History of episodic wheeze and shortness of breath Forced expiratory volume in one second (FEV1) at baseline ≥ 70% of the predicted value Able to comprehend and follow all required study procedures; willing and able to sign an informed consent form Significant acute or chronic medical or psychiatric illness Known coagulopathy, worsening of asthma or respiratory infection in the preceding 6 weeks Use of inhaled or oral corticosteroids within the last 30 days, or need for antihistamines within 72 hours of each allergen or methacholine challenge, immunosuppressives, nonsteroidal anti-inflammatory drugs, or anticoagulants (intermittent doses of short-acting β2-agonist are allowed)
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1
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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.
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eligible ages (years): 18.0-65.0, Nasal Polyps Asthma For all subjects Non smoking men or women aged 18 to 65 years old Subjects will have nasal polyps as defined above. For asthmatic subjects Subjects will have a history consistent with asthma according to the of the ATS[18] defined on the basis of episodic or persistent chest tightness, wheeze or cough in the past 6 months. At entry into the study, FEV1 will be over 70% predicted Asthma will have been stable for at least 3 months before entering the trial Asthma medication will have been stable for at least 1 month prior to the study. For non asthmatic subjects A methacholine challenge test with a PC20 (provoking concentration of methacholine to cause a 20% fall in FEV1) over 16 mg/mL For all subjects Smoking (current smoking) or ex-smoking (les than 6 months or history of more than 10 pack-year of smoking) Use of anti-leukotriene medication within the last 3 months Use of systemic corticosteroids within the last 3 months Use of anti-coagulant therapy Recent (less than 1 month) upper or lower respiratory tract infection, any other condition that may interfere with the evaluations Pregnancy, breast-feeding or planned pregnancy during the study. Fertile woman not using acceptable contraceptive measures, as judged by the investigator Subjects unable to perform or with contraindications to the tests proposed Subjects who are, in the opinion of the investigator, mentally or legally incapacitated thus preventing informed consent from being obtained. For asthmatic subjects Unstable asthma shown by respiratory symptoms and B2-agonists need more than 3 times/week and nocturnal asthma symptoms
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0
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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.
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eligible ages (years): 18.0-50.0, Allergic Asthmatic Allergy Asthma Specific allergy to House Dust Mite farinae confirmed by positive immediate skin test response. 2. Oxygen saturation of > 94 % at baseline 3. Blood pressure within the following parameters (Systolic between 140 Diastolic between 90-60 mm Hg) 4. Moderate or severe persistent asthma according to NHLBI definitions including history of one of the following: 1. Episodic wheezing, chest tightness or shortness of breath consistent with asthma occurring at least once a week that may affect activity 2. Asthma symptoms occurring at night or during sleep at least 1 time per week 3. measured FEV1 or FVC is <80% of predicted OR 4. Physician diagnosed moderate or severe persistent asthma which is currently treated or controlled with maintenance medication including moderate or high dose inhaled corticosteroid, or any dose of inhaled corticosteroid and a long-acting inhaled B2-agonist Any chronic medical condition considered by the PI as a contraindication to receiving gamma-T, including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, chronic thyroid disease, kidney disease or coagulation defects. 2. Use of inhaled steroids, cromolyn or leukotriene inhibitors (Montelukast or Zafirlukast) which have been used for at least one month are allowed. Patients must be on a stable regimen of maintenance asthma therapy which has not changed in the past month prior to entrance into the study. 3. Non-steroidal Anti-Inflammatory Drugs (NSAIDS) or aspirin (ASA) use within 48 hours of beginning the study, and inability to suspended use of these medications during the length of the study. 4. Use of anticoagulants including warfarin, heparin, or clopidogrel. 5. Diagnosis of anemia or abnormal blood counts at screening. Abnormal PT or PTT values at screening (PT that is prolonged more than 1-2 sec and PTT prolonged more than 3-5 sec of normal. The normal values used will be those defined by McLendon lab.) 6. Pregnancy or nursing a baby. As this is a phase I study, the potential risk to a fetus cannot be justified. 7. Children will not be included in this study as the potential risk to a growing child cannot be justified. 8. Adults age 51 and older are excluded as the potential for concomitant illness in this population increases the risk for confounding the data. 9. Known vagal response to venipuncture 10. Use of any tobacco product within the past 6 months 11. Hypertension, classified as a systolic blood pressure of equal to or greater than 140, and a diastolic blood pressure equal to or greater than 90
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0
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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.
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eligible ages (years): 18.0-999.0, Asthma Diagnosis of asthma Are pregnant Take hormonal medication Have an illness with fever (> 38.0 ˚ C or 100.4 ˚ F) within 24 hours of Visit 1 or between Visits 1 and 2 Are participating in another interventional research trial Have other major chronic illnesses that would interfere with participation Are taking the following medications: leukotriene receptor antagonists, oral steroids, anticoagulants, or insulin Are unable to provide consent
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0
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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.
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eligible ages (years): 18.0-50.0, Asthma • 18-50 years old + years old with prior approval to begin an exercise program from primary care physician within 6 months of enrollment Men and women Asthma Doctor diagnosed asthma Lung function tests must meet certain levels common in asthma patients Active, daily doctor-prescribed asthma controller medication (inhaled corticosteroid) for 2 months or longer at a minimum dose equivalent to fluticasone 88 mcg/day, about two (2) puffs. (you can be on other drugs as long as they are in the same dose range as fluticasone) Poor asthma control: Any one of the following conditions Use of beta-agonist (A bronchodilator medicine that opens the airways by relaxing the muscles around the airways that may tighten during an asthma attack )for asthma symptoms twice/week or more OR Awakening from sleep with asthma symptoms more than once per week OR One or more control problems identified on the Asthma Treatment and Control Questionnaire (ATAQ). Smoking status • Poor lung function Current participation in a regular aerobic exercise program (formal or at home) Any "yes" to any one of items a-e of question number two of the Stanford Usual Activity Questionnaire Pregnancy Sudden illness that accompanies fever (> 38.00 C or 100.40F) within 24 hours of Visit 2 Participation in another interventional research trial Other major chronic illnesses that would interfere with participation in the study Medication use Chronic oral corticosteroid use Oral corticosteroid use within 4 weeks of study start Anti-coagulants (An anticoagulant is a drug that helps prevent the clotting (coagulation) of blood.), insulin, any investigative drugs within 2 months Drug allergy: • Previous adverse effects from methacholine challenge Non-adherence Inability or unwillingness to provide consent
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1
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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.
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eligible ages (years): 18.0-50.0, Rhinitis, Allergic, Perennial Rhinitis, Allergic, Seasonal Asthma Specific allergy 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 FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .75 (without use of bronchodilating medications for 12 hours), consistent with lung function of persons with no more than mild episodic or mild persistent asthma History of nasal allergy, including episodic, perennial, or seasonal sneezing, nasal congestion or cough, or such symptoms associated with specific exposures (such as cat or dog) for classification as having asthma with allergic rhinitis vs. allergic rhinitis alone History of episodic wheezing, chest tightness, or shortness of breath consistent with asthma, or physician diagnosed asthma Provocative concentration of methacholine producing a 20% fall in FEV1 (PC20 methacholine) of less than 10 mg/ml by the method used (see below) Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, or chronic thyroid disease Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months Use of systemic steroid therapy within the preceding 12 months for an asthma exacerbation. All use of systemic steroids in the last year will be reviewed by a study physician Use of inhaled steroids, cromolyn or leukotriene inhibitors (Montelukast or zafirkulast) initiated within the past month (except for use of cromolyn exclusively prior to exercise). Patients must be on a stable regimen of therapy and shown to be stable Use of daily theophylline within the past month Pregnancy or nursing a baby Cigarette smoking > 1 pack per month Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma Exacerbation of asthma more than 2x/week which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. (Not to prophylactic use of albuterol prior to exercise)
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1
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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.
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eligible ages (years): 18.0-64.0, Asthma Adults age 18-64 years old. 2. Doctor diagnosis of mild persistent asthma. Persistent asthma is defined by NAEPP guidelines as asthma symptoms (cough/wheeze/dyspnea/exercise limitation)of greater than 2 times/week daytime or greater than 2 times/month at night over the previous month but less than continual and less than 5 nights/week. 3. FEV1 greater than 60% predicted for age/gender/race/height based on normative data. 4. No unscheduled asthma related health visit in the 1 month prior to enrollment 5. School or work days missed less than or equal to 2 in the previous month for asthma. 6. Albuterol use less than 8 doses (2 puffs or one neb) in past week. 7. Ability to speak and understand English. 8. Telephone access. 9. Women of childbearing potential must confirm that they will use birth control while in the study and have a negative urine pregnancy screen at baseline Pregnant women, prisoners. 2. Chronic illness (other than asthma, allergic rhinitis and eczema) such as renal disease, diabetes, hypertension or terminal disease or abnormal vital signs: T> 100.3F, HR>130 bpm, SBP>155 mmHg, or DBP>100 mmHg, RR>25 bpm, or pox<93% room air. 3. Unable to perform spirometry, necessary for lung function assessment. 4. Received probiotic in past 6 months. 5. Subject or household member has immunosuppression such as HIV, history of organ transplantation, present cancer or chemotherapy, primary immune disease, or is taking an immune modulating drug. 6. Severe persistent asthmatics who have continual daily or frequent (greater than 5 nights/week) asthma symptoms and/or FEV1 less than 60% predicted . 7. Diarrhea or constipation (symptoms more than once in the past week) 8. Unable to feed orally or to consume cornstarch 9. Lung disease other than asthma (e.g. COPD, cystic fibrosis, lung cancer, bronchiectasis, interstitial lung disease). 10. Subjects at increased risk of developing infective endocarditis such as those with a history of cardiac surgery, IV drug abuse, recent invasive medical procedures or dental work (recent = last month). 11. Allergy to Vancomycin or Cefepime. The parameters of intestinal barrier function, intestinal flora, serum inflammatory cytokines, IgE, will have no ranges as these will be collected over time on product as a way of describing the population characteristics of study participants
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1
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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.
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eligible ages (years): 18.0-90.0, Asthma symptomatic asthma usage of inhaled or oral corticosteroids recent febrile respiratory infection severe, unstable asthma
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1
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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.
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eligible ages (years): 18.0-999.0, Asthma Mild asthma FEV1 > 70% predicted Positive methacholine challenge
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1
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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.
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eligible ages (years): 18.0-999.0, Healthy Volunteer Fatigue Depression To be included, participants must meet the following Healthy, 18 years of age or older Speak and understand the English language Participants with any one of the following will be excluded Inability to provide informed consent for the study Are unwilling or unable to cooperate with the study procedures or travel to NIH for the procedures Have a confirmed medical condition causing clinically significant fatigue symptom (e.g. congestive heart failure, cancer actively receiving therapy, sleep disorders) Currently taking medications that cause fatigue (e.g. diuretics, beta blockers, narcotics) Working late evening and night shifts within the past month Have severe psychiatric conditions (e.g. major depressive disorder, bipolar disorder, anxiety disorder, schizophrenia, drug and/or addiction abuse or dependence) Report consuming more than 300mg of caffeine containing beverages (approximately 4 cups of coffee or 8 cups of soda or tea) or food (approximately 1 lb of chocolate) within 24 hours Reports consuming more than 2 servings of alcohol containing beverages every day and with detectable blood alcohol content (BAC) using breath analyzer (greater than 1 mg/dL of BAC) Pregnant or lactating women
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0
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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.
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eligible ages (years): 18.0-55.0, Mild to Moderate Persistent Asthma Male or female asthmatics, any racial group. Females of childbearing potential must practise two forms of contraception Aged 18 to 55 years inclusive Non smokers for at least the past 12 months with a pack history of less than 10 pack years Mild to moderate persistent asthma according to GINA4 guidelines for at least 12 months Receipt of prescribed or over the counter medication within 14 days prior to the first study day
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1
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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.
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eligible ages (years): 18.0-60.0, Asthma for People with Asthma A physician diagnosis of asthma, consistent clinical history, and either 1) airway hyperresponsiveness indicated by a 20% or greater decrease in forced expiratory volume at one second (FEV1) in response to inhalation of methacholine at 8 mg/mL or less, or 2) bronchodilator-responsive expiratory airflow limitation (if FEV1 less than 70% of predicted value or less than 1.5 L, improving at least 200 mL and 12% in response to 180 μg of albuterol aerosol). Patients with NA should meet the above and demonstrate an overnight decrease in peak flow of 20% or greater on at least four of seven nights at home. for all Participants Able to follow directions for Participants with Asthma Use of oral steroids within 2 weeks of study entry Use of cromolyn, leukotriene antagonist, or theophylline within 1 week of study entry History of cognitive or other neurological disorder Active symptoms of Diagnostic and Statistical Manual IV (DSM-IV) for any major psychiatric disorder, alcohol abuse, or substance abuse History of, or concurrent, unstable or serious medical illness Shift work History or evidence of chronic obstructive pulmonary disease (COPD) Tobacco smoking within the last month, or history of smoking greater than 5 pack-years Pregnancy or the desire to become pregnant during the study period
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1
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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.
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eligible ages (years): 5.0-15.0, Bronchial Asthma Children aged 5-15 years of either sex seeking treatment with mild exacerbation of asthma in pediatric chest clinic or Pediatric OPD 2. Mild exacerbation will be defined as children presenting with increase in symptoms (cough, wheeze, breathlessness) for less than 7 days duration no chest indrawing no difficulty in speech clinical asthma score (or pulmonary index score-annexure 1) between 6-9 Children with life threatening asthma detected by presence of any of the following severe chest indrawing cyanosis irregular respiration altered sensorium 2. Children with other chronic respiratory conditions like tuberculosis, cystic fibrosis or other acute illness that would complicate current treatment and response for asthma 3. If child has taken salbutamol in last 6 hours or if he is on long acting beta agonists (formoterol or salmeterol) 4. Child not able to perform spirometry 5. Parents refusing to give consent
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1
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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.
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eligible ages (years): 0.0-999.0, Allergic Rhinitis Patients who are treated with Nasonex for perennial or seasonal allergic rhinitis Patients with an infection for which there is no effective antimicrobial drug or systemic fungal infection [symptoms may exacerbate] Patients with a history of hypersensitivity to any ingredient of this drug
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1
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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.
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eligible ages (years): 18.0-50.0, Fibromyalgia Age 18-50 2. Meet american college of rheumatology for fibromyalgia 3. at baseline report an average pain of 4 or more on a brief Pain Inventory. 4. can climb 2 flights of stairs without shortness of breath new medication change in the last 2 months 2. any cardiac disease at all 3. known thyroid disease before or after thyroid screening bloodwork 4. unstable medical or psychiatric disease. 5. Known inflammatory or rheumatic disease other than fibromyalgia 6. substance abuse in the last year 7. suicidality or depression as indicated by a Beck Depression Inventory of 30 or above 8. concomitant herbal medications 9. multiple severe medication allergies 10. the assessment of the research team that of the subject could in some way compromise the safety and validity of the study. 11. diabetes 12. smoking 13. Known uncontrolled hypertension 14. known uncontrolled hypercholesterolemia
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0
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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.
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eligible ages (years): 18.0-45.0, Asthma asthmatics below 18 and above 45 COPD patients no mobile phone not using the prescribed asthma inhalation medication
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2
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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.
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eligible ages (years): 18.0-75.0, Asthma Non-smoker male and female adult patients aged 18-75 years inclusive, who have signed an informed consent form prior to initiation of any study-related procedure, including any adjustments to asthma medication prior to screening Patients with asthma, receiving daily treatment with inhaled corticosteroid Patients with a forced expiratory volume in 1 second (FEV1) during screening of ≥ 50% of the predicted normal value for the patient Body mass index (BMI) must be within the range 18-32 kg/m^2 (inclusive) Able to communicate well with the investigator and comply with the requirements of the study A urine cotinine level greater than the local laboratory lowest level of quantification (LOQ of 500 ng/ml or lower) Patients who have had a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening Patients who have had an emergency room visit for an asthma attack/exacerbation within 6 weeks prior to screening or any time between screening and pre-dose on day 1 of the study Patients who have had a respiratory tract infection within 4 weeks prior to screening or any time between screening and pre-dose on day 1 of the study Patients who require the use of ≥ 8 inhalations per day of the short-acting β2-agonist salbutamol/albuterol (100 μg/90 μg salbutamol/albuterol metered dose inhaler [MDI] or equivalent dose of a dry-powder inhaler [DPI]) on any 2 consecutive days from screening to randomization Patients diagnosed with chronic obstructive pulmonary disease (COPD) as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (2008) Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation. Previous participation in a study with either the investigational or comparator drugs does not a patient from participation in this study Significant illness History of being immunocompromised, including a positive human immunodeficiency virus (HIV) test result (ELISA and Western blot) A positive hepatitis B surface antigen (HBsAg) or hepatitis C test result
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2
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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.
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eligible ages (years): 8.0-65.0, Asthma Well-defined history of physician diagnosed asthma Any ethnic background to 65 years old Baseline pre-bronchodilator FEV1 of 40% to 80% predicted for age, height, and gender No oral corticosteroid use, emergency room visits, or hospitalizations within the previous 3 months Nonsmokers or less than a 5 pack-year history with no smoking in the previous year Normal physical exam and no confounding diseases were selected Able to withhold inhaled short-acting b2-agonists or inhaled anticholinergic drugs for 8 hours, oral antihistamines for 5 days, theophylline for 24 hours, and cromolyn, nedocromil, and inhaled corticosteroids for 2 hours prior to the study
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1
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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.
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eligible ages (years): 18.0-60.0, Asthma Male or female, aged 18 to 60 years Diagnosed with asthma, defined as episodic chest tightness, wheezing and dyspnoea, cough Non-Smoker or Ex-Smoker for at least 10 years and a smoking history of less than 5 pack years History of asthma symptoms for more than 10years Receiving as required short acting bronchodilators Post bronchodilator FEV1 50 to 100 % predicted Evidence of airway calibre reversibility within the previous 12 months: reversibility to salbutamol of 12% following 400mcg inhaled salbutamol, histamine PC20 < 8mg/ml, diurnal variation in peak expiratory flow of 20% Able to produce sputum after induction with saline Cardiac or pulmonary disease other than asthma Respiratory infection defined as fever, nasal/sinus congestion, fatigue, cough, antibiotic use or yellow/green sputum within 4 weeks prior to study Receiving inhaled or oral corticosteroid therapy, long acting Beta2 agonist therapy or leukotriene modifying therapy for the previous 1 month Severe or uncontrolled co-morbid disease Pregnancy or breastfeeding Unable to give written informed consent
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1
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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.
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eligible ages (years): 18.0-999.0, Severe Persistent Asthma Adults (18 and older) with physiologically confirmed SA or mild-moderate asthma and followed by an asthma specialist for at least 6 months Must agree to have regular clinic visits (minimum 3-4 per year for SA, 1-2 for mild-moderate asthma) Must have good compliance with medications Patients with asthma and COPD Malignancy and other significant medical conditions that will impact follow up within this program Those less than 18 years of age Concomitant interstitial lung disease, sarcoidosis, other significant lung disease Those who have had a transplant Significant travel with work Unable to make appointments (every three to six months over 2 years) Those residing in another country or planned absence for more than one month
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2
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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.
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eligible ages (years): 18.0-65.0, Asthma Body weight ≥ 50 kg and ≤ 150 kg at Visit 1 Chest radiograph within 12 months of Visit 1 without evidence of a clinically significant abnormality Stable asthma Asthma exacerbation during screening Known malignancy Known immunodeficiency Pre-existing lung disease other than asthma Uncontrolled clinically significant medical disease Current smoker History of substance abuse that may impair or risk the patient's full participation in the study, in the judgment of the investigator Prior allergic reaction to a monoclonal antibody Patients (men and women) of reproductive potential who are not willing to use contraception Pregnancy
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1
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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.
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eligible ages (years): 18.0-60.0, Allergic Rhinitis Positive history of allergen specific seasonal allergic rhinitis Positive screening skin prick test (wheal diameter > 3 mm) Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication Signed and dated patient´s Informed Consent Previous immunotherapy within the last 3 years Simultaneous participation in other clinical trials Other reasons contra-indicating an into the trial according to the investigator´s estimation (e.g. poor compliance) Auto-immune disorders Severe chronic inflammatory diseases Malignancy Alcohol abuse Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs
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2
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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.
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eligible ages (years): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs
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0
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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.
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eligible ages (years): 18.0-999.0, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin
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0
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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.
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eligible ages (years): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination
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0
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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.
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eligible ages (years): 18.0-50.0, Asthma Age 18-50 years Diagnosis of allergic rhinitis and/or mild asthma Pre-albuterol forced expiratory volume in the first second (FEV1) of >70% predicted Skin test positive to house dust mite (D. farinae), short ragweed or cat hair Documented negative Tuberculin skin test (PPD) within the last 12 months or a medical history that is consistent with a low probability of exposure to tuberculosis (i.e. the subject is not a health worker, has not traveled to endemic areas, and has no pre-existing medical or social risk factors for tuberculosis) At least a 20% decrease in FEV1 during the immediate response following inhaled antigen challenge Safety laboratory assessments within normal ranges (labs to complete blood count with differential, blood urea nitrogen, creatinine, Prothrombin time, Partial Thromboplastin Time and platelet count) Women of child-bearing potential (WCBP) must have a negative urine pregnancy test (urine HCG) within 48 hours of the methacholine challenge at Visit 2, within 48 hours of the inhaled allergen challenge at V3 and on the day of the segmental allergen challenge on Visit 5. WCBP must agree to use a reliable method of birth control for the duration of the study (reliable methods of birth control can abstinence, barrier methods, oral contraceptives, injection contraceptives or skin absorption contraceptives) In the opinion of the investigator, capable and willing to grant written informed consent and cooperate with study procedures and requirements Major health problems such as autoimmune disease, heart disease, type I and II diabetes, uncontrolled hypertension or lung diseases other than asthma. The listed health problems are definitive but decisions regarding major health problems not listed will be based upon the judgment of the investigator No pre-existing chronic infectious disease Any condition for which, in the opinion of the investigator, transient oxyhemoglobin desaturation is inadvisable Pregnant or lactating females or has a planned pregnancy during the course of the study Medication other than for asthma, allergies or contraception (e.g. monoamine oxidase inhibitors and beta-adrenergic antagonists in any form) Inhaled corticosteroids or oral corticosteroids within 1 month of screening Upper or lower respiratory infection within 1 month of screening Unstable asthma as indicated by self report of increased symptoms or increased beta-agonist use over the 2 weeks preceding the screening visit Current smokers (defined as smoked within the last year) or a former smoker with a history of >5 pack years Obesity as defined by a Body Mass Index (BMI) >30
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0
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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.
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eligible ages (years): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded
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0
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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.
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eligible ages (years): 18.0-999.0, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy
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0
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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.
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eligible ages (years): 18.0-45.0, Bronchial Asthma Known history of asthma (intermittent wheezing, cough, dyspnoea responsive to inhaled short acting beta agonists) FEV1 >65% of predicted on at least two occasions at screening At the screening allergen challenge, a decrease in FEV1 of ≥20% in the early asthmatic reaction and of ≥15% in the LAR to allergen on 3 separate occasions between 3-10hrs post allergen, 2 of which must be consecutive No steroid usage in the past 12 weeks Testing positive to skin prick challenge with at least one of the following allergens: house dust mite, pollen or cat hair within the previous 12 months Non smokers for a minimum of 6 months; less than 10 pack year history Respiratory tract pathology other than allergic asthma Lower respiratory tract infection within 4 weeks prior to an allergen challenge Receipt of prescribed or OTC medication other than paracetamol or short acting inhaled beta agonists within 14 days of screening or of the first day of each dosing period
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1
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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.
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eligible ages (years): 18.0-65.0, Asthma Cough Variant Asthma Subjects with asthma or suspected CVA who have previously participated in or who have expressed interest in participating in studies will be invited to participate in the study. Previous treatment with inhaled or systemic corticosteroids is not an criterion, but medication use will be recorded and examined in the analysis An exacerbation necessitating any alteration in medication, emergency department visit or hospitalizations within the previous 4 weeks; 2. Inability to perform acceptable quality spirometry; 3. Medical contraindications to methacholine challenge testing 35, including: 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 L); 6. Inability to perform acceptable quality spirometry; 7. Current use of cholinesterase inhibitor medication (for myasthenia gravis); and 8. Pregnant or nursing mothers. 4. Smoking history in excess of 10 pack years; 5. Medical contraindications to mannitol challenge testing, including: 1. Aortic or cerebral aneurysm; 2. Uncontrolled hypertension; and 3. Myocardial infarction or a cerebral vascular accident in the previous six months). 6. Women who are pregnant or breastfeeding because the effects of a possible hyperresponsiveness reaction to mannitol in mothers and/or fetuses are unknown and many compounds are excreted in human milk therefore caution should be taken
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1
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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.
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eligible ages (years): 19.0-55.0, Allergic Rhinitis Male or female subjects with seasonal allergic rhinitis (out of season) Sensitive to ragweed skin prick test and screening nasal allergen challenge Subjects with significant concomitant diseases Subjects with symptoms of allergic rhinitis in 2 weeks prior to screening Female subjects that are pregnant or nursing. Subjects with hypersensitivity to study drugs or allergen challenge
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2
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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.
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eligible ages (years): 18.0-999.0, Allergic Rhinitis 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 manifest symptoms of clinically active allergic rhinitis at the start of Visit 1 or Visit 2 known intolerance or allergy to antihistamines or corticosteroids have a compromised lung function at 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 planned surgery (nasal, ocular or systemic) during the trial period or within 30 days thereafter use disallowed medications (topical, topical ophthalmic, systemic and/or injectable treatments and all anti-allergy therapies including prescription, over the counter or homeopathy, and over the counter sleeping aids) during the study or appropriate pre-study washout period
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1
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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.
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eligible ages (years): 18.0-999.0, Cystic Fibrosis Gender: Male or female (non-pregnant, non-lactating) Cystic fibrosis documented by a compatible clinical and radiographic presentation, and sweat chloride > 60 mEq/l or 2 disease causing CFTR mutations Severity of Disease: 1. Must have FEV1 of greater than or equal to 50% of predicted at the screening visit. 2. Must have an oxygen saturation of >92% on room air as determined by pulse oximetry at the screening visit Patient or legally authorized representative agrees to the patient/individual's participation in the study by signing and dating the informed consent form after the nature of the study has been fully explained and all questions have been satisfactorily answered Unstable lung disease: As defined by a change in medical regimen during the preceding 2 weeks; an FEV1 >15% below recent (within 6 months) clinical measurements; or a significant new finding on chest radiograph (pneumothorax, lobar/segmental collapse) not considered a part of the usual, chronic progression of CF lung disease Patients unable or unwilling to be withdrawn from hypertonic saline therapy, dornase alfa, or N-acetylcysteine 3 days prior to and for the duration of each Baseline and Treatment Period will be excluded Patients unable to withhold use of long-acting bronchodilators (i.e., Salmeterol, Advair, Formoterol), anti-cholinergics, and vest therapy 12 hours prior to and for the duration of each treatment period Patients unable to withhold short-acting bronchodilator 6 hours prior to and for the duration of each treatment period except as prescribed by the study protocol Patients that have received an investigational drug or therapy during the preceding 30 days Patients that have had radiation exposure within the past year that would cause them to exceed Federal Regulations by participating in this study
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0
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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.
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eligible ages (years): 18.0-60.0, Rhinitis Male and female subjects Aged 18 to 60 years People with nasal and ocular discomfort at least sensitized to grass pollen Subject with PER allergy (persistent form) as defined by ARIA guidelines or with a recurrent history of seasonal allergic rhinitis documented by treatment intakes in his medical dossier Previous positive skin prick test or presence of specific serum IgE antibodies class II or above against timothy grass in the last 5 years. If no data are available, a test for detection of timothy grass specific serum IgE antibodies (Phadia CAP System) will be performed at the pre-inclusion visit With RQLQ score ≥ 2 Subjects agree to stop consumption of probiotics (food or dietary supplement containing probiotics) and vitamins and/or minerals during the study (D-10/D-7 to D49). Female subjects with efficient contraception and asthmatic subjects (with a controlled disease and without oral corticosteroid) can be included in the study. The baseline period prior to treatment with Lactobacillus paracasei LP-33 is 7 days. On recommendations of the consulted experts, Pr Bousquet and Pr Hamelmann, a wash-out period of 3 additional days is recommended before baseline for subject using intranasal corticosteroid before their inclusion. As a consequence, the baseline may be extended to 10 days for these subjects In case the subject consumed an anti-H1 (other than Loratadine) before his (her) he (she) will have to switch to Loratadine to be included Taking part in another clinical trial or being in the period of a previous clinical trial Presenting a psychological incapability or having a bad comprehension of the language (French or German according to the concerned country) to understand the information letter and then to sign the informed consent Refusing to sign the informed consent Adult under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision Pregnant or breastfeeding women Use of medication which could interfere with the study in the investigator's opinion (antibiotics, etc…) Subject who does not agree to stop his/her consumption of dietary supplements and foods containing probiotics and his/her supplementation of vitamins/minerals during the study (D-10/D-7 to D49)
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0
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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.
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eligible ages (years): 18.0-65.0, Asthma Patients with moderate persistent asthma Smokers Any significant disease or illness, other than asthma Other protocol-defined inclusion/
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2
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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.
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eligible ages (years): 4.0-80.0, Asthma Aged: 4-80 years: Paediatric cohort (aged 4-11 years); Adult cohort (aged 12-69 years); Elderly cohort (aged 70-80 years Evidence of asthma: i.e. a diagnostic code of asthma or ≥2 prescriptions for asthma at different points in time during the prior year, including one ICS prescription Be on current asthma therapy: i.e. ≥1 asthma prescriptions in the prior year, and at least 1 other asthma prescription during the same period Have at least one year of up-to-standard (UTS) baseline data (prior to the IPD) and at least one year of UTS outcome data (following the IPD) Diagnostic read code for chronic respiratory disease (including COPD) at any time On maintenance oral steroid therapy at baseline Any patients receiving a combination inhaler in addition to their separate ICS inhaler in the baseline year
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1
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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.
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eligible ages (years): 3.0-5.0, Intrinsic Asthma Allergic Asthma Allergy Bronchial Hyperresponsiveness informed consent age 3 to 6 years diagnosis asthma pulmonary function: FEV1 (% pred.)≥ 70% ability to carry out 2 reproducible flow volume loops moderate to severe BHR (PD20 FEV1 ≤ 0,3 mg methacholine) more than 4 weeks interval since last infection hours washout period of Short Acting Beta Agonist week washout period of Ipratropium Bromide week washout period of Long Acting Beta Agonist Age < 3 and > 6 Years Pulmonary function test: FEV1 (% pred.) < 70% Others chronic diseases or infections (e.g., HIV, tuberculosis, malignancy) Incapability to perform spirometry Current participation in another clinical trial
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1
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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.
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eligible ages (years): 18.0-999.0, NSCLC Dyspnea Histologically or cytologically proven incurable stage IIIb or stage IV non-small cell lung cancer. 2. Dyspnea as defined by a score of 2 or higher on the 10-point Dyspnea Numeric Scale (Appendix 2). 3. New dyspnea or worsening dyspnea within the last 6 months per patient reporting Age < 18. 2. An FEV1 / FVC ratio < 0.7 with an FEV1 of < 80% predicted post-bronchodilator. 3. Life expectancy < 3 months. 4. Significant worsening of dyspnea over the last week such that an acute cardiac or respiratory condition is considered likely (e.g. pneumonia, heart failure). 5. Myocardial infarction within the previous month. 6. Heart rate ≥ 120. 7. Active tuberculosis or tuberculosis receiving antibiotic therapy. 8. Current or previous use of ipratropium, tiotropium, or oxitropium (see Appendix 6). 9. Sensitivity to atropine. 10. Pre-existing diagnosis of asthma or moderate to severe Chronic Obstructive Pulmonary Disease 11. Use of beta-adrenergic bronchodilators more than once per week. 12. Use of experimental therapy with known cholinergic or adrenergic effects. 13. Uncontrolled glaucoma. 14. Urinary retention. 15. An active upper or lower respiratory infection or having taken antibiotics for any recent respiratory infection within 4 weeks. 16. Symptomatic pleural or pericardial effusion. 17. Evidence of reversible proximal endobronchial obstruction. 18. Oxygen saturation < 90%. 19. A hemoglobin of < 100 g/litre. Testing is to be within 4 weeks of randomization. 20. Calculated or urine creatinine clearance ≤ 50 mL/min (see Appendix 5 for calculation). Testing it to be within 4 weeks of randomization. 21. Weight loss > 10% of usual body weight within 6 months. 22. Known pregnancy or lactating. 23. Unable to independently fill out quality of life forms or give informed consent. -
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0
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