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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): 5.0-11.0, Asthma Physician-diagnosed asthma At least 1 exacerbation treated with systemic (oral or injectable) corticosteroids in the past 12 months Able to perform reproducible spirometry Current treatment with step 2 controller therapy [low-dose ICS, leukotriene receptor antagonist (LTRA)] OR current treatment with step 3 controller therapy [low-dose ICS + long-acting beta agonist (LABA), low-dose ICS + LTRA, or medium dose ICS] with a childhood Asthma Control Test (c-ACT) score of >19, no more than 2 prednisone treated exacerbations in the past 6 months, prebronchodilator Forced Expiratory Volume at 1 second (FEV1) ≥ 80% predicted and willing to step down therapy OR controller naïve and qualifying for step 2 controller therapy [asthma symptoms or short acting beta agonist (SABA) use > 2 days per week or night-time awakenings due to asthma > 2 nights per month] Prebronchodilator FEV1 ≥ 60% predicted Ability and willingness to provide informed assent For females of childbearing potential: not pregnant, non-lactating, and agree to practice an adequate birth control method History of clinical varicella or varicella vaccine Systemic (oral or injectable) corticosteroids within previous 2-week period Current or recent (previous 2-weeks) use of medications known to significantly interact with corticosteroid disposition, including but not limited to carbamazepine, erythromycin, phenobarbital, phenytoin, rifampin, and ketoconazole Presence of chronic or active lung disease other than asthma Significant medical illness other than asthma, including thyroid disease, diabetes mellitus, Cushing's disease, Addison's disease, hepatic disease, or concurrent medical problems that could require oral corticosteroids during the study A history of cataracts, glaucoma, or any other medical disorder associated with an adverse effect to corticosteroids History of a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure More than 5 prednisone treated exacerbations in the past 12 months More than 1 hospitalizations lasting >24 hours for asthma in the past 12 months History of adverse reactions to ICS preparations or any of their ingredients Receiving hyposensitization therapy other than an established maintenance regimen (On maintenance regimen for ≥ 3 months)
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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): 12.0-45.0, Asthma Individuals aged 12 to 45 years, for whom the pharmacists had dispensed at least one anti-asthma drug in the previous six months were screened and randomly contacted by phone. Those who reported an asthma diagnosis and who were using a short-acting beta-2-agonist (SABA) >3 times a week (except before exercise) or a corticosteroid (inhaled or oral), irrespective of frequency were included Pregnancy, no prior asthma diagnosis, participation in an ongoing respiratory study, or another respiratory illness
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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): 18.0-60.0, Asthma Adult males and non-pregnant, non-lactating females aged between 18 and 60 years (both inclusive) Patients with a confirmed 6-months' history of asthma at the time of enrolment into the trial Patients treated with short-acting beta-agonists or inhaled corticosteroids at a stable dose and regimen (up to the equivalent of 1600 μg/day of beclometasone dipropionate) for at least 4 weeks prior to screening Patients whose (pre-salbutamol) forced expiratory volume in 1 second (FEV1) at screening is >60% of the predicted normal value after a washout of at least 6 hours for short-acting beta-agonists and 48 hours for long-acting beta-agonists, if applicable Patients with a FEV1 absolute increase of at least 250 mL over baseline value after inhalation of 4 puffs of 100 μg of salbutamol in one of two pulmonary function tests performed within 10-15 min Patients with clinically significant respiratory or pulmonary diseases other than asthma or history of thoracic surgery Patients with a Body Mass Index (BMI) < 18 or > 40kg/m2 (both inclusive)
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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 Best pre-bronchodilator forced expiratory volume in 1 second (FEV1) of 40 to 85% of their predicted normal value. 2. Current Asthma Therapy: Patients must have a short-acting β2-agonist (for rescue use) for a minimum of 8 weeks before the Screening Visit (SV) and a low-dose inhaled corticosteroid (ICS). The low-dose ICS may be either as ICS monotherapy or as an ICS/long-acting beta agonist (LABA) combination. The ICS component of the patient's asthma therapy should be stable for a minimum of 1 months before providing consent. 3. Reversibility of Disease: Patients must have at least 15% reversibility (all patients) and at least a 200 mL increase from baseline FEV1 (patients age 18 and older) within 30 minutes after 2 to 4 inhalations of albuterol/salbutamol at the SV. Note: Patients who do not qualify for the study due to failure to meet reversibility will be permitted to perform a retest once within 7 days. 4. Patients must provide written informed consent/assent. For minor patients (ages 12 to 17 years, or as applicable per local regulations), the written ICF must be signed and dated by the parent/legal guardian and the written assent form must be signed and dated by the patient (if applicable). Note: Age requirements are as specified by local regulations. 5. Outpatient >= 12 years of age on the date of consent/assent. In countries where the local regulations permit enrollment of adult patients only, patients must be 18 years of age and older. 6. Asthma diagnosis: The patient has a diagnosis of asthma as defined by the National Institutes of Health (NIH). The asthma diagnosis has been present for a minimum of 3 months and has been stable (defined as no exacerbations and no changes in asthma medication) for at least 30 days. 7. The patient is able to perform acceptable and repeatable spirometry. 8. The patient is able to perform peak expiratory flow (PEF) with a handheld peak flow meter. 9. The patient is able to use a MDI device without a spacer device and a MDPI device. 10. The patient is able to withhold (as judged by the investigator) his or her regimen of ICS or study drug, and rescue medication for at least 6 hours before the SV and before all treatment visits. 11. The patient/parent/legal guardian/caregiver is capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent/assent and being compliant with all study requirements. 12. SABAs: All patients must be able to replace their current SABA with albuterol/salbutamol HFA MDI inhalation aerosol for the duration of the study. 13. Female patients may not be pregnant, breastfeeding, or attempting to become pregnant other may apply, please contact the investigator for more information A history of a life-threatening asthma exacerbation (an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest, or hypoxic seizures). 2. The patient is pregnant or lactating, or plans to become pregnant during the study period or for 30 days after the study. 3. The patient has participated as a randomized patient in any investigational drug study within 30 days of the SV. 4. The patient has previously participated as a randomized patient in a study of Fp MDPI or FS MDPI. 5. The patient has a known hypersensitivity to any corticosteroid, salmeterol, or any of the excipients in the study drug or rescue medication formulation (ie, lactose). 6. The patient has been treated with any known strong cytochrome P450 (CYP) 3A4 inhibitors (eg, azole antifungals, ritonavir, or clarithromycin) within 30 days before the SV. 7. The patient has been treated with any of the prohibited medications during the prescribed (per protocol) washout periods before the SV. 8. The patient currently smokes or has a smoking history of 10 pack years or more (a pack year is defined as smoking 1 pack of cigarettes/day for 1 year). The patient must not have used tobacco products within the past year (eg, cigarettes, cigars, chewing tobacco, or pipe tobacco). 9. The patient has a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before the SV. 10. The patient has a history of alcohol or drug abuse within 2 years preceding the SV. 11. The patient has had an asthma exacerbation requiring systemic corticosteroids within 30 days before the SV, or has had any hospitalization for asthma within 2 months before the SV. 12. Initiation or dose escalation of immunotherapy (administered by any route) is planned during the study period. However, patients on stable immunotherapy may be considered for inclusion. 13. The patient has used immunosuppressive medications within 4 weeks before the SV. 14. The patient is unable to tolerate or unwilling to comply with the appropriate washout periods and withholding of all applicable medications. 15. The patient has untreated oral candidiasis at the SV. Patients with clinical visual evidence of oral candidiasis who agree to receive treatment and comply with appropriate medical monitoring may enter the study. 16. The patient has a history of a positive test for human immunodeficiency virus (HIV), active hepatitis B virus, or hepatitis C infection. 17. The patient is either an employee or an immediate relative of an employee of the clinical investigational center. 18. A member of the patient's household is participating in the study at the same time. However, after the enrolled patient completes or discontinues participation in the study, another patient from the same household may be screened. 19. The patient has a disease/condition that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study other may apply, please contact the investigator for more information
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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 Best pre-bronchodilator forced expiratory volume in 1 second (FEV1) of 40 to 85% of their predicted normal value. 2. Current Asthma Therapy: Patients must have a short-acting β2-agonist (for rescue use) for a minimum of 8 weeks before the Screening Visit (SV) and a qualifying dose of an inhaled corticosteroid (ICS). The ICS may be either as ICS monotherapy or as an ICS/long-acting beta agonist (LABA) combination. The ICS component of the patient's asthma therapy should be stable for a minimum of 1 month before providing consent. 3. Reversibility of Disease: Patients must have at least 15% reversibility (all patients) and at least a 200 mL increase from baseline FEV1 (patients age 18 and older) within 30 minutes after 2 to 4 inhalations of albuterol/salbutamol at the SV. Note: Patients who do not qualify for the study due to failure to meet reversibility will be permitted to perform a retest once within 7 days. 4. Patients must provide written informed consent/assent.. For minor patients (ages 12 to 17 years, or as applicable per local regulations), the written ICF must be signed and dated by the parent/legal guardian and the written assent form must be signed and dated by the patient (if applicable). Note: Age requirements are as specified by local regulations. 5. Outpatient >= 12 years of age on the date of consent/assent. In countries where the local regulations permit enrollment of adult patients only, patients must be 18 years of age and older. 6. Asthma diagnosis: The patient has a diagnosis of asthma as defined by the National Institute of Health (NIH). The asthma diagnosis has been present for a minimum of 3 months and has been stable (defined as no exacerbations and no changes in asthma medication) for at least 30 days. 7. The patient is able to perform acceptable and repeatable spirometry. 8. The patient is able to perform peak expiratory flow (PEF) with a handheld peak flow meter. 9. The patient is able to use a metered dose inhaler (MDI) device without a spacer device and a multidose dry powder inhaler (MDPI) device. 10. The patient is able to withhold (as judged by the investigator) his or her regimen of ICS or study drug, and rescue medication for at least 6 hours before the screening visit (SV) and before all treatment visits. 11. The patient/parent/legal guardian/caregiver is capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent/assent and being compliant with all study requirements. 12. SABAs: All patients must be able to replace their current SABA with albuterol/salbutamol HFA MDI inhalation aerosol for the duration of the study. 13. Female patients may not be pregnant, breastfeeding, or attempting to become pregnant other may apply, please contact the investigator for more information A history of a life-threatening asthma exacerbation (an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures). 2. The patient is pregnant or lactating, or plans to become pregnant during the study period or for 30 days after the study. 3. The patient has participated as a randomized patient in any investigational drug study within 30 days of the SV. 4. The patient has previously participated as a randomized patient in a study of Fp MDPI or FS MDPI. 5. The patient has a known hypersensitivity to any corticosteroid, salmeterol, or any of the excipients in the study drug or rescue medication formulation (ie, lactose). 6. The patient has been treated with any known strong cytochrome P450 (CYP) 3A4 inhibitors (eg, azole antifungals, ritonavir, or clarithromycin) within 30 days before the SV. 7. The patient has been treated with any of the prohibited medications during the prescribed (per protocol) washout periods before the SV. 8. The patient currently smokes or has a smoking history of 10 pack years or more (a pack year is defined as smoking 1 pack of cigarettes/day for 1 year). The patient must not have used tobacco products within the past year (eg, cigarettes, cigars, chewing tobacco, or pipe tobacco). 9. The patient has a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before the SV. 10. The patient has a history of alcohol or drug abuse within 2 years preceding the SV. 11. The patient has had an asthma exacerbation requiring systemic corticosteroids within 30 days before the SV, or has had any hospitalization for asthma within 2 months before the SV. 12. Initiation or dose escalation of immunotherapy (administered by any route) is planned during the study period. However, patients on stable immunotherapy may be considered for inclusion. 13. The patient has used immunosuppressive medications within 4 weeks before the SV. 14. The patient is unable to tolerate or unwilling to comply with the appropriate washout periods and withholding of all applicable medications. 15. The patient has untreated oral candidiasis at the SV. Patients with clinical visual evidence of oral candidiasis who agree to receive treatment and comply with appropriate medical monitoring may enter the study. 16. The patient has a history of a positive test for human immunodeficiency virus (HIV), active hepatitis B virus, or hepatitis C infection. 17. The patient is either an employee or an immediate relative of an employee of the clinical investigational center. 18. A member of the patient's household is participating in the study at the same time. However, after the enrolled patient completes or discontinues participation in the study, another patient from the same household may be screened. 19. The patient has a disease/condition that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study other may apply, please contact the investigator for more information
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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): 2.0-17.0, Egg Allergy Egg allergic children Uncontrolled asthma the day of immunization severe asthma treated by oral steroids or high dose of inhaled steroids urticaria on the day of immunization antihistamines taken in the previous 3 to 7 days of immunization acute disease on the day of immunization (fever,irritability, vomiting, diarrhea, pallor, cyanosis, diaphoresis, lethargy) immunosuppressed patients or health worker who should be in contact with immunosuppressed patients
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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, Asthma in Children Anxiety Biological mothers of male and female children between 2 and 12 years of age who live with or have contact with their children English is the primary language of the biological mother Mothers of children only below 2 or above 12 years of age Mothers of children thought to have a chronic health condition other than asthma Mothers who have already completed a questionnaire with another child
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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 At least 18 years of age Physician-diagnosed asthma based on the presence of typical symptoms (wheezing, breathlessness, chest tightness, cough) Asthma confirmed by Forced expiratory volume in 1 second (FEV1) increase of at least 12% and 200 mL after inhalation of 400 mcg salbutamol And/or a provocative concentration of methacholine causing a 20% fall in FEV1 (PC20M) less than 16 mg/ml Sputum eosinophils rate less than 3% Absolute blood eosinophils count less than 400 per mm3 Treatment with a stable dose of inhaled corticosteroid (ICS) for the previous three months High risk of asthma-related death, defined by Near-fatal asthma history, requiring a stay in an intensive care unit Current using or recent discontinuation (four weeks) of oral corticosteroids (OCS) Treatment with omalizumab Pregnant women
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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): 25.0-59.0, Muscle Tightness Healthy active Duty or DoD beneficiaries between 25 and 59 years old Not on a physical profile Not taking any OTC or prescription pain medications or workout supplements
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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 of either sex aged 18 years (inclusive) Non-smokers or ex smokers. stopped smoking >= 1 year prior to screening and with a smoking history of <= 10 pack years Diagnosis of to bronchial asthma with a duration of at least 6 months with the 4 plus 5 and a diagnosis of asthma according to the WHO guidelines for at least one year Increase of asthma symptoms (wheeze, cough, shortness of breath, chest tightness) when exposure to any of the following stimuli: cold, dry air, dust, smoke, exercise and allergens Patients on a stable dosage of either mcg <= BDP (beclomethasone dipropionate) <= 1600 mcg daily or other inhaled steroid with or without inhaled long acting β2-agonists or oral xanthines at screening visit 1 for the past 4 weeks and short acting β2-agonists prn for the past 6 weeks or mcg <= BDP < 800 mcg daily or other inhaled steroid and inhaled long-acting β2-agonists (or oral xanthines), at screening visit 1 for the past 4 weeks and short acting β2-agonists prn for the past 6 weeks FEV1 >= 60% but <= 90 % predicted normal at visit 1 after withholding respiratory drugs as per section 4.2.1. Predicted normal values are based on the guidelines for standardized function testing of the European Community for Coal and Steel (ECCS) Males: FEV1 pred. (L) = 4.30 x Height (m) Patients with a history of seasonal exacerbation of asthma suggesting seasonal asthma which would not be controlled by medication allowed in the protocol (see 4.2.2) and likely to occur during the time period that the patients will be in the study History of cardiovascular, renal, neurologic, liver, immunologic or endocrine dysfunction if they are clinically significant. A clinically significant disease is defined as one which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study Patients with a recent history (<= 1 year) of myocardial infarction and/or (<= 3 years) of heart failure or patients with any cardiac arrhythmia requiring drug therapy History of cancer within the past 5 years excluding treated basal cell carcinoma Patients with current psychiatric disorders which would interfere with the conduct of the trial Patients with history or presence of glaucoma and/or posterior subcapsular cataracts Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per Patients with active tuberculosis with indication for treatment Patients with a history of cystic fibrosis, bronchiectasis, chronic bronchitis or emphysema Patients with active rhinitis requiring treatment with intranasal steroids and/or ketotifen
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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 Subjects with a known physician diagnosis of asthma with a best Forced Expiratory Volume in 1 Second (FEV1) of >70% of the predicted normal value at the Screening visit. Percent predicted will be calculated using the European Respiratory Society Global Lung Function Initiative reference equations. Subjects must abstain from short acting beta-2 agonists (SABA) use for 6 hours prior to the Screening visit During the screening visit, subjects must either demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of >=12.0% over baseline and an absolute change of >=200 millilitres (mL) within 60 minutes following 4 inhalations of albuterol/salbutamol inhalation aerosol (or equivalent nebulized treatment with albuterol/salbutamol solution) or in the absence of reversibility have documented evidence of a physician diagnosed asthma for at least 6 months Male/females aged between 18 and 65 years of age inclusive, at the time of signing the informed consent Body weight >= 50 kilograms (kg) and body mass index (BMI) within the range 18 0 kilogram/square meter (kg/m^2) (inclusive) A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy for this definition, "documented" refers to the outcome of the investigator's/designee's review of the subject's medical history for study as obtained via a verbal interview with the subject or from the subject's medical records; or postmenopausal defined as 12 months of spontaneous amenorrhea. In questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milliinternational units per/millilitre (MIU/mL) and estradiol <40 picogram/millilitre (pg/mL) (<147 picomoles per liter [pmol/L]) is confirmatory. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods, if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.; Child-bearing potential with negative pregnancy test as determined by serum or human chorionic gonadotropin (hCG) test at screening or urine hCG test prior to dosing AND ; Agrees to use one of the contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until the follow-up visit.; OR has only same-sex partners, when this is her preferred and usual lifestyle Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form Subjects who are current non-smokers and who have a pack history of <=10 pack years. A subject may not have used inhaled tobacco products within the past 3 months (i.e., cigarettes, cigars or pipe tobacco). [number of pack years = (number of cigarettes per day / 20) x number of years smoked] Alanine transaminase (ALT), alkaline phosphatase and bilirubin <= 1.5x Upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) Based on single or averaged corrected QT interval (QTc) values of triplicate electrocardiogram (ECGs) obtained over a brief recording period: QT duration corrected for heart rate by Fridericia's formula (QTcF) <450 milliseconds (msec); or QTcF <480 msec in subjects with Bundle Branch Block Based Upon Medical Histories Any clinically relevant medical condition or abnormality identified during the screening medical assessment and procedures, physical examination, or laboratory assessments (including clinical chemistry and haematology), which in the opinion of the Investigator and/or GSK Medical Monitor is likely to affect the safety of the subject and/or interfere with the study procedures and outcomes Acute exacerbation of asthma in the last 6 months prior to the Screening visit Subjects on treatment with fluticasone propionate either as monotherapy or in combination at a total daily dose higher than 500 mcg or budesonide monotherapy or in combination at a total daily dose higher than 800 mcg or beclomethasone (CFC) at a total daily dose higher than 1000 mcg or beclomethasone (HFA) at a total daily dose higher than 400mcg are excluded from the study Subjects with other significant pulmonary diseases (pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities other than asthma) Use of oral/injectable/depot corticosteroid for any indication within 3 months prior to the Screening visit Use of any anti immunoglobulin E (Anti-IgE) (e.g. Xolair) in any period prior to screening Use of intra-nasal steroids (INS). To be eligible for the study, patients on INS therapy will be required to switch to non-INS therapy at screening Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) History of regular alcohol consumption within 6 months of the study defined as: For Australian sites: An average weekly intake of >21 units for males or >14 units for females. One unit (= standard drink) is equivalent to 10 g of alcohol: 270 mL of full strength beer (4.8%), 375 mL of mid strength beer (3.5%), 470 mL of light beer (2.7%), 250 mL pre-mix full strength spirit (5%), 100 mL of wine (13.5%) and 30 mL of spirit (40%); For South African sites: An average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 grams (g) of alcohol: a half-pint (approximately 330 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits
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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, Medication Reconciliation unscheduled patients admitted to the Emergency Department at Randers Regional Hospital at weekdays during daytime (9 am to 16.15 pm) or more drugs prescribed patients triage red patients who cannot give informed consent terminal patients patients admitted to detoxification patients refered to the acute outpatient department patients remaining in the Emergency Department overnight
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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, Allergic Rhinitis Participant is a healthy, ambulatory male or female volunteer 18 to 55 years of age Participant has a history of Seasonal Allergic Rhinitis due to ragweed for the last two consecutive ragweed seasons Participant has a positive response (wheal diameter greater than or equal to 3 mm larger than diluent control) to a skin prick test to short ragweed allergen at screening or within 12 months of screening visit Participant is a female that is pregnant, lactating or actively trying to become pregnant smokers Participant is unable to comply with the washout periods for prohibited medications Participant is currently receiving allergen specific immunotherapy injections
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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): 18.0-40.0, Asthma Asthmatic symptoms during the last year and at least one criterion of the below: 1. current FEV1-increase of minimum 12% after b2-agonist, 2. positiv Methacholintest, 3. Day-to-day FEV1-variation of at least 20% during a two-week period. 4. Positive mannitol test. Furthermore, all of the below At least 10 packyears At least 10 cigarettes per day within the last year Age 18-40 years Asthmatics who have been treated with inhaled corticosteroids (ICS), systemic corticosteroids, leukotrien-antagonists (LTA), long-lasting b2-agonists, anticholinergic medicine or varenicline within the last 3 months 2. Lower respiratory tract infections, including pneumonia, within the last 6 weeks. 3. Patients suffering from other chronic respiratory disease than asthma, such as sarcoidosis and COPD will also be excluded. 4. Pregnant and nursing women will be excluded as well as women planning pregnancy during the study period. 5. A history of allergy towards study drugs will lead to exclusion. Patients who during the study period develop lower respiratory infections or due to severe uncontrolled asthma receive treatment with any of the above listed types of medicine will be excluded. Patients who are diagnosed with other chronic respiratory disease than asthma during the study period will also be excluded, as well as patients who during the study period require more asthma medicine than the planned study medication. Any participant who wishes to leave the study, for any reason, including unacceptable side-effects, during the study period will be excluded, as well as anyone who wants to withdraw their recorded data from the project after the study period has ended. In case of unacceptable side-effects to varenicline resulting in immediate cessation of treatment with this drug, the participant will continue visits unchanged, but he/she will be excluded from the calculations of tobacco cessation succes-rate. However, varenicline cessation up to 4 weeks after treatment start with varenicline will result in and replacement of the participant. Cessation of treatment with budesonide will result in from the rest the study. The person will not be replaced. The data recorded from the participant until the last visit before cessation will be used. Allergic reactions towards study drugs will result in immediate cessation of the drug, and possible as described in the above. -
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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 Dyspnea Wheezing Presenting to the Emergency Department with cough, wheezing and/or dyspnea (shortness of breath) Referred for CXR and/or CT scan Life threatening medical condition requiring immediate treatment Unable to sit up for a chest ultrasound Unable to consent Pregnant Unable to speak, read and write in English
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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): 35.0-90.0, Asthma Chronic Obstructive Pulmonary Disease will be anybody whose regular treatment requires inhaled medication. They will be included regardless of age, disease, inhaler device used or cognition The only will be if a willing participant is not on an inhaler of any type
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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, Non-allergic Rhinitis idiopathic rhinitis patients with at least 2 persistent (> 12w) rhinological symptoms (nasal discharge, sneezing, nasal congestion) for an average of at least 1 h per day idiopathic rhinitis patients with a total nasal symptoms score (TNS) of 5 or more on a visual analogue scale (VAS) Age > 18 and < 65 years Written informed consent Willingness to adhere to visit schedules Adequate contraceptive precautions in female patients with childbearing potential Patients with concomitant allergic rhinitis, demonstrated by positive skin prick test (Hal reagents) and/or immunoglobins E in blood. * Patients with structural abnormalities: nasal polyps, severe septal deviation (septum reaching concha inferior or lateral nasal wall), septal perforation, hypertrophy of the inferior turbinates Patients with local allergic rhinitis (LAR) or entopy Systemic steroid treatment less than 4 weeks before the in the study, nasal steroid spray less than 4 weeks before the oral leukotriene antagonists or long-acting antihistamines less than 2 weeks before the inclusion Inability of the patient to stop taking medication affecting nasal function like ß-blockers History of prolonged use or abuse of decongestant nasal spray like xylometazoline spray and/or use or abuse of decongestive oral medication Evidence of infectious rhinitis/rhinosinusitis or common cold within 4 weeks prior to inclusion Pregnancy or lactation. ** Any disorder of which might compromise the ability of a patient to give truly informed consent for participation in this study Enrollment in other investigational drug trial(s) or receiving other investigational agent(s) for any other medical condition
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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 Written informed consent is obtained before conducting any study-related procedures The patient is a man or woman aged 18 to 80 years as of the screening visit The patient is experiencing non-specific respiratory symptoms defined as follows: Cough and/or wheeze and/or chronic dyspnoea for ≥ 6 weeks prior to visit 1 Patients displaying an FEV1< 90% predicted at visit 1, will also need to show a reversibility to a short-acting beta-agonist of < 20% at visit 1 or within the previous year Women of childbearing potential (post-menarche or less than 2 years post-menopausal or not surgically sterile) must be willing to commit to using a medically accepted method of contraception for the duration of the study. Accepted methods of contraception intrauterine devices (IUD), systemic contraception e.g. steroidal contraceptives (oral, implanted transdermal or injected), barrier methods with spermicide, and partner vasectomy The patient has ever been diagnosed with asthma as evidenced by the UK quality outcome framework approved Read code as well as a reversibility of ≥ 20% predicted The patient has received oral, inhaled or systemic corticosteroids, a leukotriene modifier or long-acting-beta-agonist within four weeks prior to visit 1. All therapy and treatment other than those outlined are permitted during the study The patient has a significant chronic respiratory disorder other than asthma, e.g. COPD (fixed obstruction, post-bronchodilator) cystic fibrosis, severe and untreated bronchiectasis or interstitial lung disease The patient has a significant medical condition that would make it unlikely for the patient to complete the study The patient has a known significant risk factor for cough or wheeze, including but not limited to: taking an ACE inhibitor, severe untreated rhinitis, or significant gastroesophageal reflux disease The patient is asymptomatic (ACQ < 1) after the initial 2-week assessment The patient has had a respiratory tract infection as judged clinically, within four weeks prior to visit 1, or displays an acute respiratory tract infection at the time of the study The patient is a pregnant woman or intends to get pregnant (Any woman becoming pregnant during the study will be withdrawn from the study)
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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): 2.0-11.0, Fever Wheezing are 2 through 11years of age, 2. have a visit at a study site anytime during the study period, 3. receive first dose or second dose of LAIV4 or IIV in the season, 4. the parent has a cell phone with text messaging capabilities, and 5. the parent and child > 7 years of age speaks English or Spanish at the Columbia sites or English at the Boston site presence of fever ≥100.4 at time of vaccination, 2. administration of any antipyretic in the 6-hour period prior to vaccination, 3. stated intent, at time of vaccination, to use prophylactic antipyretics before the development of a fever, 4. parent only speaks a language other than English or Spanish at the Columbia sites or English at the Boston site. 5. enrollee is a child >7 years of age who only speaks a language other than English or Spanish at the Columbia sites or English at the Boston site. 6. parent's inability to read and send text messages, 7. sibling already enrolled this season (OR cell phone # already used for another child) 8. chronic medical condition considered by ACIP to be a precaution or contraindication for LAIV1 (except for asthma), 9. current asthma exacerbation, or exacerbation in the last 2 weeks 10. use of oral or other systemic steroid within the last 2 weeks
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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 give their signed and dated written informed consent to participate prior to commencing any study related activities Subjects must be outpatients >=12 years of age at Visit 1 who have had a diagnosis of asthma, as defined by the National Institutes of Health, for at least 12 weeks prior to Visit 1 (Note: Countries with local restrictions prohibiting enrollment of adolescents will enroll subjects >=18 years of age only) Subjects may be male or an eligible female. An eligible female is defined as having non-childbearing potential or having childbearing potential and a negative urine pregnancy test at Screening and agrees to use an acceptable method of birth control consistently and correctly Subjects must have a FEV1 of >=80% of the predicted normal value Subjects are eligible if they have received mid dose ICS plus LABA (equivalent to FP/salmeterol 250/50 twice daily or an equivalent combination via separate inhalers) for at least the 12 weeks immediately preceding Visit 1 All subjects must be able to replace their current SABA treatment with albuterol/salbutamol aerosol inhaler at Visit 1 for use, as needed, for the duration of the study. Subjects must be able to withhold albuterol/salbutamol for at least 6 hours prior to study visits If in the opinion of the investigator the subject's asthma is well controlled History of Life-Threatening Asthma, defined for this protocol as an asthma episode that required intubation and/or associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 5 years Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1 and led to a change in asthma management or in the opinion of the Investigator, expected to affect the subject's asthma status or the subject's ability to participate in the study Any asthma exacerbation requiring oral corticosteroids within 12 weeks of Visit 1 or resulting in an overnight hospitalization requiring additional treatment for asthma within 6 months prior to Visit 1 A subject must not have current evidence of Atlectasis, Bronchopulmonary dysplasia, Chronic bronchitis, Chronic obstructive pulmonary disease, Pneumonia, Pneumothorax, Interstitial lung disease, or any evidence of concurrent respiratory disease other than asthma A subject must not have any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbated during the study A subject must not have used any investigational drug within 30 days prior to Visit 1 or within five half-lives (t½) of the prior investigational study, whichever is longer of the two Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of inhaler, inhaler or FP 250 History of severe milk protein allergy Administration of prescription or non-prescription medication that would significantly affect the course of asthma, or interact with study drug A subject must not be using or require the use of immunosuppressive medications during the study
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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, Pulmonary Disease, Chronic Obstructive Subject must be 18 years of age or older Subject has been diagnosed as having asthma and/or COPD Informed consent is required for independent sites initiating this protocol
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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): 18.0-80.0, Asthma Allergy Reactive Airway Disease Lung Diseases, Obstructive Asthma The diagnosis of asthma will be based on a consistent history, physical exam, and previous physician diagnosis of asthma. Consistent historical features of asthma episodic wheezing, shortness of breath, chest tightness, or cough, often precipitated by known environmental triggers (e.g. respiratory viral infection, exposure to pollen, exercise, or stress). Consistent physical findings of asthma audible expiratory wheezing and findings of associated diseases (e.g. eczema, allergic rhinitis), although the physical exam may be normal in between asthma attacks. Subjects will need to be free of asthma symptoms at time of challenge testing. Most asthmatic subjects should demonstrate bronchial reactivity during the mannitol challenge test. Non-asthmatic controls Healthy control subjects will be recruited in order to define baseline values for serum and urine mannitol. Healthy control subjects will be defined by the lack of symptoms or physical findings of asthma or other allergic diseases (e.g. eczema, allergic rhinitis), and absence of any other chronic lung disease. Healthy subjects should also not demonstrate bronchial reactivity during a mannitol challenge test >5 pack year history of tobacco use or active smoking. 2. Other chronic or active lung diseases (e.g. COPD, pulmonary fibrosis, lung cancer) 3. History of significant renal insufficiency of liver disease 4. Asthma subjects with severe disease according to NAEPP guidelines (e.g. severe ongoing symptoms despite high-dose inhaled or oral glucocorticoids) 5. Asthma subjects with a baseline FEV1<65% predicted 6. Asthma subjects unwilling or unable to withhold medications prior to testing 7. Pregnant women
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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 Participants must meet all of the following for enrollment: 1. Male or female, 18 to 60 years of age 2. Must have clinical evidence of moderate-severe atopic asthma: -self-reported symptoms suggestive of asthma (such as wheezing, chest tightness, shortness of breath, cough nocturnal symptoms) within the past year, and a positive methacholine test confirming diagnosis [provocative concentration causing a 20% fall in forced expiratory volume in 1 second (PC20 FEV1) <16 mg/mL for participants on inhaled corticosteroids and <8 mg/mL for participants not on inhaled corticosteroids] or postbronchodilator FEV1 with at least 12% or 200 mL increase in FEV1 or forced volume vital capacity (FVC) on bronchodilator challenge, and no other diagnosis that could explain symptoms. If there is documentation of a recent methacholine challenge, those results may be used in lieu of conducting a secondary methacholine challenge. 3. Permanently resides within 50 miles of the CRU. 4. Able to present a valid government issued form of identification for entry to the NIEHS campus 5. Able to receive asthma treatment medication(s) via mail 6. Willingness to comply with instructions regarding medication regimen, diet, and life style as directed by the investigator that are required per protocol 7. Access to a vacuum cleaner with a detachable hose component Bronchoscopy Sub-Study Criterion In addition to the above participants must be able to fast for 6 hours (no food or drink, except a small amount of water if needed to take approved medications) prior to the bronchoscopy visit in order to be eligible for enrollment in the bronchoscopy sub-study Participants meeting any of the following at screening will not be eligible for enrollment or to continue with study visits: 1. Women who are pregnant or lactating at the time of screening will not be encouraged to enroll. However, if a woman is found to be pregnant at a screening or baseline visit, she may remain in the study but will not be eligible for the methacholine challenge or bronchoscopy sub-study until no longer pregnant or breastfeeding (this is in place because methacholine may pose an undue risk on the unborn fetus or nursing babies; women who become pregnant after completing the baseline visit will not be excluded from further participation but will also not be eligible for participation in the bronchoscopy sub-study). 2. Current smoker, significant second-hand smoke exposure (defined by urine cotinine >200 ng/mL at screening), or a history of smoking greater than 5 pack years. Smoking encompasses all inhaled products, including e-cigarettes. 3. piCO Smokealyzer value of >11ppm 4. History of the following comorbidities: chronic obstructive pulmonary disease, cystic fibrosis (CF), emphysema, non-CF bronchiectasis, pulmonary fibrosis, sarcoidosis, unstable angina, pulmonary hypertension 5. Allergy or history of adverse reactions to methacholine 6. Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with required study procedures 7. Comorbid diseases that affect global health or survival such as DVT, pulmonary embolism, class III IV congestive heart failure, or a malignancy under treatment Bronchoscopy Sub-Study In addition to the above participants meeting any of the following will not be eligible for enrollment into the bronchoscopy sub-study: 1. Pregnant, as indicated by urine pregnancy test 2. Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with bronchoscopy 3. Bleeding disorders 4. Facial deformity, major facial surgery 5. Asthma exacerbation or respiratory infection less than or equal to 4 weeks prior to study visit 6. Severe persistent asthma, defined as by ATS-ERS criteria. 7. Allergy or history of adverse reactions to lidocaine 8. Temperature >37.6 (Infinite)C; blood pressure <90/50 mm Hg or >160/100 mm Hg; pulse rate <50 or >100 beats/minute 9. Body weight <50 kg (<110 lbs) 10. The following abnormal lab values (values obtained during clinical assessment) Platelet count <100,000 per microliters White blood cells count <3000 per microliters Absolute neutrophil count <1000 per microliters Hematocrit <35% for both female and male Prothrombin time (PT) / abnormal international normalized ratio (INR) and partial prothromboplastin time (PTT) based on reference laboratory established reference ranges
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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, Atrial Fibrillation ≥ 18 years of age Patients of African, European, and Hispanic descent History of typical or early-onset symptomatic (≥2 episodes/month) paroxysmal/persistent AF ECG that was recorded within 1 month of randomization showing AF Eligible for both Flecainide(Class I) and Sotalol (Class III) AAD Able to give informed consent Permanent AF or isolated atrial flutter Cardiac or thoracic surgery within the previous 6 months Previous use of amiodarone other than short-term use (e.g. for an acute arrhythmia in hospital) Medical condition that is likely to be fatal in less than one year A history of prior AF ablation Have already been tried on 2 or more AADs in the past for AF Creatinine clearance <40 ml/min Left ventricular ejection fraction < 50% Contra-indication to a Class I AAD e.g., structural heart disease, or history of MI Contra-indication to a Class III AAD, e.g., congenital or acquired long QT syndrome with QTc>480 ms in females and >460 ms in males at baseline
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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 Clinical diagnosis of asthma Fulfil the for difficult asthma (defined as persistent symptoms and/or frequent exacerbations despite treatment at step 4 or step 5 of the British TYhoracic Society / SIGN asthma guidelines 2011) Adult patients age between 18 and 70 years Able to speak, read and write in English All patients must have received their regular medication from the same Community Pharmacy for at least 3 months prior to their baseline visit Their community pharmacy must be registered with Leeds Primary Care Trust(PCT) to undertake targeted Medicines Use Reviews (tMURs) Failure to meet the Patient is not responsible for administering their own medications Patient is unlikely to be available for the 6-month follow-up period Failure to provide written informed consent Patient has had an MUR within the 12 months preceding the study period
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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, Crohn Disease Colitis, Ulcerative Intestinal Helminthiasis The included volunteer is a researcher within parasitology with main focus on Trichuris trichiura and Trichiura suis. He planned to infect himself and contacted our department with the purpose of being monitored during this infection for safety (medical supervision) and research reasons. The only clinical criterion for his in the study was that he was healthy N/A
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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, Ischemic Preconditioning Patients with aneurysmal subarachnoid hemorrhage whose initial angiogram show an aneurysm and patients with clipped aneurysm will be eligible for enrollment Patients will be enrolled within 96 hours of bleeding onset, if informed consent is obtained from the participant or health care proxy, as appropriate Hunt Hess Scale > 4 Inability to undergo limb preconditioning due to local wound or tissue breakdown, history of peripheral extremity vascular disease or patient discomfort Inability to obtain informed consent from the patient or a health care proxy Ankle-brachial index < 0.7 Inability to start limb preconditioning within 4 days of bleeding Inability to precondition a leg that is not-plegic (that is preserved anti gravity strength) and has not been accessed for catheter angiography Age<18 years Pregnant women Prisoners
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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, Obesity Smoking Cessation Subjects will be considered for if they meet all of the following 1. ≥18 years and ≤65 years of age; 2. smoked ≥10 cigarettes/day for the past 6 months; 3. Body Mass Index of 27-39.9 kg/m2; 4. motivated to stop smoking; 5. weight concerned as shown with the Weight Concern Scale; 6. able to participate fully in all aspects of the study; 7. understand and signed the study informed consent. 8. Subject is in good health as determined by the clinical investigators Subjects will be ineligible for participation if they have any of the following: 1. current nonspecific suicidal thoughts or a lifetime history of a suicidal attempt (defined by the Columbia-Suicide Severity Rating Scale as a "potentially self-injurious act committed with at least some wish to die, as a result of act."); 2. current moderate or severe depression as assessed by a score of ≥16 on the Center for Epidemiology Studies-Depression; 3. a lifetime history of psychosis, bipolar disorder or schizophrenia; 4. use of anti-psychotic medication within the past 30 days; 5. use of weight-loss medications within the past 30 days or current participation in a program specifically designed to help with weight loss; 6. weight fluctuations of 20 pounds or more in the past 6 months (self-report); 7. use of any treatments for tobacco dependence within the past 30 days; 8. use of an investigational drug within the past 30 days; 9. recent history (past 3 months) of abuse of or dependence on a substance other than tobacco. Including: heavy alcohol consumption (If male, drinking > 4 alcoholic beverages per day for past month and if female, drinking > 3 alcoholic beverages per day for past month); use of cocaine, heroin, club drugs (i.e., methylenedioxymethamphetamine(MDMA)/"ecstasy"), methamphetamine, or hallucinogens (e.g., LSD) at any time during the past 3 months; and use of marijuana on a weekly basis for the past 3 months 10. current use of triptans, monoamine oxidase inhibitors, selective serotonin reuptake inhibitors (SSRI), selective serotonin-norepinephrine re-uptake inhibitors (SNRI), dextromethorphan, tricyclic antidepressants (TCA), bupropion, lithium, tramadol, tryptophan, and St. John's Wort, or any other medication known to involve the serotonergic neurotransmitter system (see human subjects section); 11. uncontrolled hypertension (systolic >160 mm Hg and/or diastolic >100 mm Hg) documented on 2 separate occasions; 12. current use of medications known to interact with varenicline or lorcaserin. These can benzodiazepines, narcotics, anti-epileptics; 13. another household member or relative participating in the study; 14. known diabetes; 15. a known allergy to varenicline or lorcaserin. 16. Women who are pregnant or lactating, or who are of childbearing potential and are likely to become pregnant during the medication phase but are not willing to use a reliable form of contraception, will also be excluded. Reliable forms of contraception oral contraception, diaphragm or condom (with spermicide), injections, intrauterine device, surgical sterilization, and abstinence. 17. Has an unstable medical condition as determined by the physician investigator 18. Subject describes having a medical history of: a) unstable angina; b) myocardial infarction within the past 3 months; c) coronary angioplasty or d) an untreated cardiac dysrhythmia. 19. Subject currently has cancer [excluding non-melanoma skin cancer] not in remission 20. Known history of seizures
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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): 18.0-99.0, Total Atherosclerotic Occlusion of Radial Artery Patients referred for cardiac catheterization. - Absence of informed consent. 2: Known allergy to nitroglycerin. 3: Ad-hoc PCI 4: Previous ipsilateral TRA. 5: Warfarin or NOAC therapy. 6: Systolic blood pressure < 100 mmHg. 7: Critical aortic stenosis (AVA < 0.6 sq.cm) 8: Inability to administer unfractionated heparin. 9: Need for post-procedural use of heparin (UFH, LMWH) 10: Raynaud's disease. 11: Sheathless technique or use of > 11 cm sheath. 12: History of intractable headache of any cause OR Migraine headache
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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): 18.0-85.0, Inherited Cardiac Arrythmias Long QT Syndrome (LQTS) Brugada Syndrome (BrS) Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) Early Repolarization Syndrome (ERS) Arrhythmogenic Cardiomyopathy (AC, ARVD/C) Hypertrophic Cardiomyopathy (HCM) Dilated Cardiomyopathy (DCM) Muscular Dystrophies (Duchenne, Becker, Myotonic Dystrophy) Normal Control Subjects All patients and family members 18 years of age or older with inherited cardiac arrhythmias including LQTS, Brugada Syndrome (BrS), cathecholaminergic polymorphic ventricular tachycardia (CPVT) or early repolarization syndrome (ERS) are eligible for enrollment All enrolled patients will have undergone clinically indicated genetic testing Age <18 years >85 years pregnant women life-limiting co-morbidities immunocompromise
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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 Newly diagnosed asthma according to Global Initiative for Asthma (GINA) guideline 2014 without previous treatment of inhaled corticosteroid and long acting beta agonists 2. Patients with asthma symptoms of most days or wake up due to asthma one time per week or more 3. Patients with the presence of any risk factors of asthma according to Global Initiative for Asthma (GINA) guideline 2014 4. Patients with severe uncontrolled asthma 5. Patients with previous asthma exacerbation 6. Patients give consent form Patients with contra-indication for performing spirometry according to American Thoracic Society (ATS) and European Respiratory Society (ERS) statement of standardization for spirometry 2. Patients refuse to participate study -
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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, Dyspnea Patient in home hospice care with an estimated survival of 3-4 weeks, at risk for dyspnea secondary to lung cancer, COPD, or heart failure Family caregiver in patient's home must speak and read English Patients with bulbar ALS or quadriplegia
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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): 18.0-84.0, Cough Diagnosis of non-asthmatic chronic cough defined as a cough experienced for a period of at least 8 weeks Negative methacholine challenge (within past year) Chest x-ray with absence of gross abnormality that could justify the cough or be a cause for the cough (within past 6 months) Male or female 18 years or older Willing and able to limit to 1 or less alcohol beverage per day (example: 360 ml of beer or 330 ml of cooler or 120 ml of wine) Concurrent use of Gabapentin or Pregabalin for other indications (seizure disorder, chronic pain) History of allergy / intolerance or adverse effect with Gabapentin or Pregabalin Concurrent use of central nervous system depressants (i.e. opioids or benzodiazepines) Not able to limit daily alcohol intake as recommended in the Creatinine clearance < 60ml/min within past three months Current Smoker or has been quit less than 8 weeks Symptoms of post nasal drip History of gastroesophageal reflux. Only participants with untreated Gastroesophageal Reflux Disease (GERD) or less than 8 weeks of therapy will be excluded Symptoms of upper airway cough syndrome ACE inhibitor use
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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 COPD for Asthma History consistent with asthma: episodic wheezing, shortness of breath, or cough Airway lability recognized by at least 12% improvement in Forced Expiratory Volume (FEV1) after 2 puffs of beta2 agonist Age >18yrs FEV1 >40% predicted Never smoker, current smoker, or quit smoking ≥5 years ago for COPD History consistent with COPD: dyspnea with exertion, productive cough, progressive course Smoking history of at least 20 pack years Current smoker or quit smoking ≥5 years ago Age >18yrs FEV1: Forced Vital Capacity (FVC) ratio < 0.70 following 2 puffs of albuterol for Asthma Other respiratory illness other than asthma Chronic infectious process Significant other medical illness Inability to consent Pregnancy for COPD Other respiratory illness other than COPD Chronic infectious process Significant other medical illness Inability to consent
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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): 12.0-75.0, Asthma Adult male or female subjects of non-childbearing or of childbearing potential committed to consistent and correct use of an acceptable method of birth control Diagnosed with asthma, as defined by the National Asthma Education and Prevention Program (NAEPP),5 at least 6 months prior to screening Moderate-to-severe asthma with a pre-bronchodilator FEV1 of >45% and <85% of predicted normal, measured at least 6 hours after short-acting β agonist (SABA)and at least 24 hours after the last dose of long-acting β agonist (LABA), at the screening visit and on the day of treatment >15% and >0.20 L reversibility of FEV1 within 30 minutes following 360 mcg of albuterol inhalation (pMDI) Patients should be stable on their chronic asthma treatment regimen for at least 4 weeks prior to enrollment Currently non-smoking; having not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and having < 10 pack-years of historical use Able to replace current regularly scheduled short-acting β agonists (SABAs) with salbutamol/albuterol inhaler for use only on an as-needed basis for the duration of the study (subjects should be able to withhold all inhaled SABAs for at least 6 hours prior to lung function assessments on study visits) Willing to discontinue their asthma medications (inhaled corticosteroids and long-acting β agonists) during the run-in period and for the remainder of the study Willingness to give their written informed consent to participate in the study Life-threatening asthma, defined as a history of asthma episodes(s) requiring intubation, and/or associated with hypercapnia, respiratory arrest or hypoxic seizures, asthma-related syncopal episodes(s), or hospitalizations within the past year or during the run-in period Significant respiratory disease other than asthma (chronic obstructive pulmonary disease (COPD), interstitial lung disease, etc.) Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia. In addition,historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases that, in the opinion of the investigator, would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbated during the study Patients who required systemic corticosteroids (for any reason) within the past 4 weeks Hypersensitivity to any sympathomimetic drug (e.g., formoterol or albuterol) or any inhaled, intranasal, or systemic corticosteroid therapy Patients currently receiving β-blockers
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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, Severe Acute Respiratory Infection A history of feverishness or measured fever of ≥ 38 deg C Cough Dyspnoea (shortness of breath) OR Tachypnoea • No
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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, Resident Education and Assessment of Difficult and High Acuity Scenarios That Focus on Cardiac Anesthesia Resident physicians who have completed at least one month of cardiac rotation are included.This high fidelity simulation lab course if offerred to every resident that meets the criteria.This is a part of their educational activity.At the beginning of the course they are given the option to participate in the survey.If they do not wish to participate in the survey it will not affect their education.Participitaion in the survey is purely voluntary Resident physicians that did not wish to participate in filling out the survey or not able to fill out the survey
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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 Participant(s) who meet all of the following are eligible for enrollment. Participant(s) may be reassessed if not initially eligible. Participants are eligible if they Have a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the Inner City Asthma Consortium (ICAC) Manual of Procedures (MOP) Have a diagnosis of asthma made by a clinician >1 year prior to recruitment Have had at least 2 asthma exacerbations in the prior year, defined as a requirement for systemic corticosteroids and/or hospitalization Have the following requirement for asthma controller medication at the Screening and Enrollment Visit (Visit 0) according to the MEDS program[4, 2] For participants aged 6 to 11 years, treatment with at least fluticasone 250 mcg 1 puff twice daily or its equivalent For participants ages12 years and older, treatment with at least Advair 250/50 mcg 1 puff twice daily or its equivalent Have peripheral blood eosinophils >=150 per mm^3. Results can be obtained from participation in a previous ICAC study if obtained within 6 months of the Screening and Enrollment Visit (Visit 0) Currently a non-smoker Parent/legal guardian is willing to sign the written informed consent Participant(s) who meet any of the following are not eligible for enrollment but may be reassessed. Participant(s) are ineligible if they Are currently pregnant or lactating Are currently receiving treatment with anti-immunoglobulin E (anti-IgE) therapy or have had anti-IgE therapy in the previous 3 months prior to screening Are currently receiving immunotherapy Have clinically significant abnormalities on complete blood count (CBC) with differential as determined by the site study clinician. Results can be obtained from participation in a previous ICAC study [including Registry for Asthma Characterization and Recruitment 2 (RACR2), NCT02513264} if obtained within the last 6 months of Visit 0 Was treated with systemic corticosteroids for any medical condition including an asthma exacerbation within the 2 weeks prior to Visit 0 Have had a cold in the previous 7 days Are currently participating in an asthma-related pharmaceutical study or intervention study or has participated in another asthma-related pharmaceutical study or intervention study in the previous 4 weeks prior to recruitment Are currently requiring greater than fluticasone 500 mcg bid plus long-acting beta agonist (LABA) 1 puff twice daily or its equivalent and\or individuals using oral corticosteroids daily or every other day at Visit 0. Participants who meet any of the following are not eligible for enrollment and may not be reassessed. Participants are ineligible if they Have any medical illnesses that in the opinion of the investigators would a.) increase the risk the participant would incur by participating in the study, b.) interfere with the measured outcomes of the study, or c.) interfere with the performance of the study procedures. Examples of such diseases are: phenylketonuria, cystic fibrosis, bronchiectasis, Type 1 diabetes, hemophilia, Von Willebrands disease, sickle cell disease, cerebral palsy, rheumatoid arthritis, lupus, psoriasis, hyperimmunoglobulin E syndrome, parasite infections, Wiskott-Aldrich syndrome, or allergic bronchopulmonary aspergillosis
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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, Hamstring Tightness Hamstring 90/90 extensibility goniometric measurement of more than 20 degrees of knee flexion bilaterally Ability to perform a squat to 90 degrees of knee flexion without assistance of the upper extremities Asymptomatic during walking History of systemic neurological or arthritic condition History of bony or peripheral nerve trauma or surgery lower extremities History of treatment with dry needling No contraindications to dry needling
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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, Acute Chest Pain Acute Coronary Syndrome Eighteen years and older 2. Presenting to the ED 3. With acute chest pain or suspected ACS 4. Symptoms occurring within 24 hours 5. Informed consent from patient or next of kin Chest pain caused by trauma 2. Persisting or recurrent chest pain caused by rheumatic diseases or cancer 3. Transferred from another grade II or grade III hospital 4. Presenting to the ED again within 30 days after initial enrollment
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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, Asthmatic Bronchitis The patients with classic asthma Asthmatic patient 1. Male or female patients aged ≥ 18 and ≤ 65, who have signed an Informed Consent form prior to initiation of any study-related procedure. 2. The patients with classic asthma had a history of episode dyspnea and wheezing with or without cough. 3. Clinical diagnosis of asthma confirmed by a chest physician according to international guidelines (GINA 2014); methacholine airway hyperresponsiveness (provocative concentration of methacholine causing a 20% fall in FEV1(forced expiratory volume at one second )【PD20】),>12% improvement in FEV1 10 min after inhaling 200ug of salbutamol. 4. None of the patients with classic asthma had used inhaled or oral corticosteroids, long-acting β2-agonists, leukotriene antagonists, sodium cromoglycate,or nedocromil sodium, anticholinergic agents, during four weeks prior to entry into the study. The patients with CVA 1. Male or female patients aged ≥ 18 and ≤ 65, who have signed an Informed Consent form prior to initiation of any study-related procedure. 2. The diagnosis of CVA is based on isolated cough lasting for ≥ 8 weeks without wheezing or dyspnea, airway hyperresponsiveness (AHR), and relief of cough with bronchodilators according to recommendations in the Chinese national guidelines on the diagnosis and management of cough. 3. None of the patients with CVA had used inhaled or oral corticosteroids, long-acting β2-agonists, leukotriene antagonists, sodium cromoglycate,or nedocromil sodium, anticholinergic agents, during four weeks prior to entry into the study. The patients with EB 1. Male or female patients aged ≥ 18 and ≤ 65, who have signed an Informed Consent form prior to initiation of any study-related procedure. 2. The diagnosis of EB is based on cough lasting for ≥ 8 weeks according to recommendations in the Chinese national guidelines on the diagnosis and management of cough. 3. None of the patients with EB had used inhaled or oral corticosteroids, long-acting β2-agonists, leukotriene antagonists, sodium cromoglycate,or nedocromil sodium, anticholinergic agents, during four weeks prior to entry into the study. Healthy subjects 1. Male or female patients aged ≥ 18 and ≤ 65, who have signed an Informed Consent form prior to initiation of any study-related procedure. 2. Normal spirometry: baseline FEV1 ≥ 80% of the predicted normal value, FEV1/FVC(forced vital capacity) > LLN (lower limit of normal). 3. Normal airways responsiveness. 4. Healthy subjects have no any disease or negative allergen skin prick test results Patients with classic asthma, CVA and EB The presence of any of the following will a subject from study enrolment: Current smokers, ex-smokers. Individuals with respiratory infection during the previous one month. Clinical history of chronic obstructive pulmonary disease(COPD), bronchiectasis, pulmonary embolism. Clinical history of haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease, or any condition that might compromise the results or interpretation of the study. Asthma exacerbation and unstable asthma . Pregnant or lactating women
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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, Acute Pain clavicular fracture with internal reduction physical status I III contraindication to regional anaesthesia history of neck radiotherapy patient suffering from chronic pain severe respiratory disease
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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): 14.0-65.0, Asthma Clinically diagnosed Asthmatic patients aged from14 to 65 years； Had a had a normal chest radiographic result； Had a baseline spirometry with the forced expiratory volume in one second (FEV1) of not less than 60% predicted； Without acute upper respiratory tract infection for the past 2 weeks Smokers； Had a poor cooperation to the test or limited understandings Had a past confirmed history of respiratory disease other than bronchial asthma (COPD, bronchiectasis, pulmonary thromboembolism, etc.) or other severe systemic disease（myocardial infarction, malignant tumor, etc.） Pregnancy or breast-feeding women Taken related drugs before measurements（Leukotriene receptor antagonists (LTRA) for 5 days，oral glucocorticosteroid or anti-histamine for 3 days，oral xanthenes or long-acting bronchodilators for 2 days，inhaled corticosteroid or long-acting bronchodilator for a day , short-acting bronchodilator for 4 hours ）
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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 Rhinitis Adults and children from the age of 12 years on, who are diagnosed with recurrent seasonal allergic rhinitis (SAR) caused by grass pollen. A previous specific immunotherapy finished at least five years ago had to be successful Contraindications according to the patient information leaflet
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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 A subject will be eligible for in this study only if all of the following apply Age: >=18 years of age at Screening at Visit 1 Diagnosis: Asthma as defined by the National Institutes of Health Reversibility of Disease: Demonstrated historical reversibility of >=12% and >=200 millilitre (mL) reversibility of Forced Expiratory Volume in One Second (FEV1) within 10-40 minutes following 2-4 inhalations of albuterol inhalation aerosol (or equivalent nebulized treatment with albuterol solution) within 24 months of Visit 1 Current asthma Therapy: Currently receiving maintenance (with one or more of the following therapies: e.g. inhaled corticosteroid alone or in combination with long-acting bronchodilators, such as long-acting beta 2-agonist [LABA]) inhaler therapy (with no prior or ongoing use of inhaler) for the treatment of asthma. Subjects must be able to continue using their currently prescribed asthma maintenance inhaler therapy throughout the study and as needed short acting betaadrenergic agonist (SABA) for rescue use Ability to Use Inhalers: Subject must be able to demonstrate correct use of inhaler within three attempts at Visit 1 Males Females who are not pregnant or not planning a pregnancy during the study or not lactating Capable of giving signed and dated written informed consent as described in protocol which includes compliance with the requirements and restrictions listed in the consent form and in this protocol Subject understands and is willing, able, and likely to comply with study procedures and restrictions A subject will not be eligible for in this study if any of the following apply Chronic Obstructive Pulmonary Disease (COPD): Subjects with a current diagnosis of COPD Asthma medications: Receiving only inhaled short-acting beta-adrenergic agonists, i.e., albuterol as their daily asthma therapy (as needed [prn] or regularly scheduled). Has changed maintenance asthma treatment within 4 weeks prior to Screening/Visit 1 or plans to change asthma treatment within 4 weeks of Visit 1 Asthma/Exacerbations/Hospitalization: Any asthma exacerbation, defined as deterioration of asthma requiring the use of systemic corticosteroids (oral, parenteral or depot) within 4 weeks of Visit 1. A subject must not have any hospitalisation or emergency department visit due to asthma within 3 months of Visit 1. Subjects with poorly controlled or who have unstable asthma, in the investigator's judgment that would affect subject's ability to evaluate "ease of use and correct use". History of life-threatening asthma, defined an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures Other Respiratory Disorders: Subjects with other respiratory disorders, including active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, or pulmonary disease (including, but not confined to chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, bronchopulmonary dysplasia, and chronic obstructive pulmonary disease), interstitial lung diseases or other active pulmonary diseases Other Disease Abnormalities: Historical or current evidence of clinically significant or rapidly progressing or unstable cardiovascular, neurological, cardiovascular, neurological, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the affect the analysis if the disease/condition exacerbated during the study. Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study Oropharyngeal Examination: Subjects with clinical visual evidence of oral candidiasis at Visit 1 are not eligible Compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures, or unable to continue their current asthma medications Tobacco Use: Current smokers or subjects with a smoking history of 10 pack-years or more (e.g., 20 cigarettes/day for 10 years) are not eligible. A subject may not have used tobacco products within the past year (i.e., cigarettes, cigars, or pipe tobacco) Alcohol and Drug Abuse A known or suspected history of alcohol or drug abuse within the last 2 years
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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): 17.0-70.0, Cough chronic cough group: 1. cough lasting ≥ 8 weeks,characterized by irritating dry cough. 2. sensitive to fumes，dust,the odorous and cold air. 3. with normal chest x-rays. 4.17-70 years old. 5.without smoking history. healty controls group: 1.17-70 years old. 2.without smoking hitory or stop smoking for more than 2 years. 3.without chronic cough. 4.without chronic respiratory diseases. 5.without chronic heart, liver, kidney,and autoimmune disease. 6.with normal chest x-rays. 7.with normal pulmonary ventilation function,and histamine challenge test showed negative result chronic cough group and healty controls group: 1. with respiratory tract infection within 8 weeks. 2. with chronic respiratory diseases or severe heart, liver, kidney,and autoimmune disease. 3. using Angiotensin-Converting Enzyme Inhibitors(ACEI),bronchodilators,glucocorticosteroid,antihistaminics within one week. 4. women during pregnancy or lactation. 5. patients with malignant tumours
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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 General man or woman age ≥ 18 years asthma inform consent signed affiliated to health insurance Specific : asthma with proximal airways obstruction GROUP Maximal Voluntary Ventilation (MMV)<80% MMV / Forced Vital Capacity (FVC)≤70% Carbon Monoxide Transfer Coefficient (KcO)>80% Specific : asthma with small airways dysfunction GROUP Maximal Voluntary Ventilation (MMV)≥80% pregnant woman or breastfeeding patient participating to other biomedical research patient who have participated to other biomedical research within the past 3 months patient refusing to sign the inform consent Specific Patient who stopped smoking since less than 12 months Pathological state related to obstructive distal airway damage Broncho-pulmonary infectious disease within the past 4 weeks Solid tumor curated by chemotherapy or chest radiotherapy Chronic respiratory disease Asthma exacerbation within the past 3 months
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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, Coronary Artery Disease Chest Pain Adult male and female adult subjects (age greater than 18 years) Referred for cardiac computed tomography angiography (CCTA), myocardial perfusion scintigraphy (MPS), or diagnostic invasive coronary angiography (ICA) Female patients that identify themselves as pregnant or have a positive pregnancy test prior to cardiac imaging History (present or past) of leukemia or lymphoma History of radiation therapy X-ray examination or scintigraphy within the last 72 hours History of coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention) Patients undergoing percutaneous coronary intervention at completion of diagnostic left heart catheterization
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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 A physician diagnosis of asthma FEV1 lower than 60% predicted clinical condition other than asthma
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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): 28.0-65.0, Chronic Periodontitis Subjects with moderate to severe Chronic Generalized Periodontitis Not undergone any major periodontal treatment in past 6 months Otherwise clinically healthy patients Any known systemic diseases specially Diabetes and other major diseases Patients on anti-inflammatory drugs or antibiotics Patient allergic to any material used for the study Pregnant and lactating mothers Periodontal therapy in past 6 months Smoker and tobacco chewer
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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 Rhinovirus Picornaviridae Infections Common Cold Age 18--55 years Male or female Clinical diagnosis of asthma for at least 6 months prior to screening An Asthma Control Questionnaire (ACQ) Score >0.75 Positive histamine challenge test (PC20 <8 µg/ml, or <12 µg/ml and bronchodilator response ≥ 12%) Worsening asthma symptoms with infection since last change in asthma therapy Positive skin prick test to common aeroallergens (e.g. animal epithelia, dust mite) Treatment comprising inhaled corticosteroids (ICS) or combination inhaler (Long -Acting Beta Agonist with ICS), with a daily ICS dose of at least 100mcg fluticasone or equivalent Participant is willing for their GP to be informed of their participation English speaker Presence of clinically significant diseases other than asthma, which, in the opinion of the investigator, may either put the patient at risk because of participation in the trial, or diseases which may influence the results of the study or the patient's ability to take part in it Smoking history over past 12 months Seasonal allergic rhinitis symptoms at screening Asthma exacerbation or viral illness within the previous 6 weeks Current or concomitant use of oral steroids, anti--leukotrienes or monoclonal antibodies Pregnant or breast-feeding women (patients should not be enrolled if they plan to become pregnant during the time of study participation) Contact with infants <6 months or immunocompromised persons, elderly and infirm at home or at work Subjects who have known evidence of lack of adherence to medications and/or ability to follow physician's recommendations
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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): 16.0-70.0, Asthma All patients must be able to give informed consent. The definition of severe asthma will be on the basis of Uncontrolled asthma: three or more of the following features present in any week in the previous 4 weeks Daytime symptoms more than twice per week Any limitation of activities Nocturnal symptoms once or more per week Need for reliever treatment more than twice per week Pre bronchodilator FEV1 <80% predicted or personal best OR Frequent severe exacerbations (≥2 per year) OR Require prescription of daily or alternate day oral corticosteroids (OCS) to achieve asthma control despite the prescription of high dose inhaled corticosteroids (>1000mcg fluticasone propionate daily or equivalent) or maintenance oral corticosteroids plus a long acting beta agonist or one other controller medication (for example anti-cholinergics, leukotriene receptor antagonists or theophylline) • Current smoker, or Ex-smoker with a >10 year pack history or having smoked within the past 6 months Significant alternative diagnoses that may mimic or complicate asthma, in particular dysfunctional breathing, panic attacks, and overt psychosocial problems (if these are thought to be the major problem rather than in addition to severe asthma) Significant other primary pulmonary disorders in particular pulmonary embolism, pulmonary hypertension, interstitial lung disease and lung cancer Subjects with emphysema and bronchiectasis should only be excluded if this is thought to be the major pulmonary disorder rather than in addition to severe asthma Diagnosis or current investigation of occupational asthma Any subjects currently participating, or having participated within 3 months of the first dose in a study using a new molecular entity, or the first dose in any other study investigating drugs
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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, Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Informed consent will be obtained before any study-related activities. Study-related activities are any data collection from the medical records of the patient Age at least 18 years at the time of Tresiba® initiation T1DM or insulin-treated T2DM patients Switched to Tresiba® (with or without prandial insulin) after any basal insulin (with or without prandial insulin). Switch must have occurred at least 6 months prior to data collection and the patient may or may not be treated with Tresiba® at the time of patient selection Previously treated with any basal insulin (with or without prandial insulin) for at least 6 months prior to switching to Tresiba® At least one documented medical visit in the first 9 months after Tresiba® initiation Minimum available data at the time of Tresiba® initiation: age, type of diabetes, HbA1c (Glycated haemoglobin), duration of diabetes, duration and type of insulin treatment, medical follow-up at the study site of at least 1 year, and an eGFR (Estimated glomerular filtration rate )value in the last 12 months Previous participation in this study. Participation is defined as having signed the Informed Consent Participation in a diabetes clinical trial or receipt of any investigational medicinal product up to 12 months before or any time after the initiation of Tresiba® Current participation in another non-interventional study on insulin degludec (Tresiba®) Patients treated by continuous subcutaneous insulin infusion or premix insulin in the 6 months prior to receiving Tresiba®
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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): 14.0-65.0, Influenza 1 Aged 14-65 from the outpatients who presented with influenza-like illness (ILI).ILI was defined as a sudden onset of fever (≥ 38°C) with respiratory tract symptoms and at least one of the following symptoms: muscle ache, headache, extreme fatigue or poor activity. 1.2 Confirmed infection by the influenza A or B virus or the new influenza A (H1N1) virus according to virological examination. 1.3 Acute onset within 72 hours. 1.4 Axillary temperature ≥38℃, with at least two of the following symptoms, headache, body discomfort, muscle pain, aversion to cold or cold chills, fatigue; along with either one of the respiratory symptoms from cough, sore throat and nasal symptoms. 1.5 Voluntarily signed informed consents With one of the following are excluded from the study. 2.1 Aged <14 or >65. 2.2 Chest imaging (X-ray or CT) confirmed bronchitis, pneumonia, pleural effusion, interstitial lesions, etc. 2.3 Routine blood test when screening displayed WBC>10.0x109/L, or NEUT. ≥75%. 2.4 Patients coughing purulent sputum or with suppurative tonsillitis. 2.5 Patients with diabetes or serious underlying disease, such as blood disease, severe COPD (FEV1 / EVC < 70%, FEV1 of expected value < 50%; or respiratory failure or right heart failure), severe hepatic insufficiency (ALT or AST 3 times above normal or higher); severe renal insufficiency (serum creatinine > 2 mg/dL); chronic congestive heart failure (NYHA heart function level Ⅲ IV), psychiatric diseases. 2.6 Have already taken antiviral drugs (amantadine, rimantadine, zanamivir and oseltamivir phosphate, etc.) or related Chinese medicine or Chinese patent medicine after the onset before the screening. Or patients have taken Choulingdan or Chinese patent medicine with Choulingdan as part of the ingredients within 1 week before the onset. 2.7 Allergic to Choulingdan or its preparations composition, to oseltamivir or its ingredients, and to drug simulation ingredients, or allergic constitution. 2.8 Women in pregnancy or lactation period, women of childbearing age with plan of a pregnancy. 2.9 Patients with immune deficiency, such as malignant tumor, organ or bone marrow transplantation and AIDS, or taking immunosuppressant in 3 months. 2.10 With dubious or confirmed alcohol and drug abuse history. 2.11 Patients that have been in a similar drug clinical study in 3 months. 2.12 Suffered from acute respiratory infection, otitis media or sinusitis 2 weeks before. 2.13 Having vaccination of a seasonal or new influenza A (H1N1) vaccine 6 mouths before. 2.14 Other reasons that researchers think not fitting to participate in the study
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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 volunteers aged 18-65 years with persistent asthma and on inhaled corticosteroids (at least 400 micrograms beclomethasone dipropionate equivalent dose daily) Current smoker Forced Expiratory Volume in 1 second (FEV1) ≥ 60 % predicted Ability to give informed consent Agreement for their General Practitioner to be made aware of study participation and to receive feedback as relevant to the participant's well being Other significant respiratory diseases, in the opinion of the investigator, such as COPD or bronchiectasis An asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 month of the study commencement or 3 months if hospital admission was required Any clinically significant medical condition that may endanger the health or safety of the participant Participation in another drug trial within 30 days before the commencement of the study Pregnancy or lactation Unable to comply with the procedures of the protocol Unable or unwilling to consent
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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 All patients must be able to give informed consent. The definition of the severity of their asthma will be according to the GINA (Global Initiative for Asthma) guidelines dependent on the amount of therapy needed to control asthma. The investigators will also at least 45 patients with severe asthma defined on the basis of: Uncontrolled asthma: three or more of the following features present in any week in the previous 4 weeks Daytime symptoms more than twice per week Any limitation of activities Nocturnal symptoms once or more per week Need for reliever treatment more than twice per week Pre bronchodilator FEV1 <80% predicted or personal best OR Frequent severe exacerbations (≥2 per year) OR Require prescription of daily or alternate day oral corticosteroids (OCS) to achieve asthma control despite the prescription of high dose inhaled corticosteroids (>1000mcg fluticasone propionate daily or equivalent) or maintenance oral corticosteroids plus a long acting beta agonist or one other controller medication (for example anti-cholinergics, leukotriene receptor antagonists or theophylline). Diagnosis of asthma for the asthma cohort: Subjects must have asthma according to one or more of the following documented in the last 12 months improvement in FEV1 ≥ 12% and 200ml predicted after inhalation of 400 mcg salbutamol airway hyper-responsiveness (PC20 <8mg/ml) Current smoker, or Ex-smoker with a >10 year pack history or having smoked within the past 6 months Significant alternative diagnoses that may mimic or complicate asthma, in particular dysfunctional breathing, panic attacks, and overt psychosocial problems (if these are thought to be the major problem rather than in addition to severe asthma) Significant other primary pulmonary disorders in particular pulmonary embolism, pulmonary hypertension, interstitial lung disease and lung cancer Subjects with emphysema and bronchiectasis should only be excluded if this is thought to be the major pulmonary disorder rather than in addition to severe asthma Diagnosis or current investigation of occupational asthma Any subjects currently participating, or having participated within 3 months of the first dose in a study using a new molecular entity, or the first dose in any other study investigating 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): 18.0-999.0, Chest Pain Dyspnea ED patients with a chief complaint of chest pain or shortness of breath Cardiac Ultrasound ordered by provider as part of diagnostic workup All providers have already reviewed the ultrasound images (unable to obtained pre- ultrasound assessment) Age < 18 Known to be pregnant
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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 Symptoms of persistent asthma for at least one year History of asthma treatments including "as-needed" inhaled short-acting beta-agonists (albuterol/salbutamol); stable doses of inhaled corticosteroids (ICS), combination ICS/long-acting (inhaled) Beta2-adrenergic agonist (LABA) and/or oral asthma controller(s) Must be able to discontinue or taper asthma controlling medications while receiving Montelukast No history of smoking or no smoking for at least 1 year, with a smoking history of no more than 10 pack-years Body Mass Index (BMI) of 15 kg/m^2 to 40 kg/m^2 Females must not be pregnant (negative serum human chorionic gonadotropin test) or breastfeeding and must not plan to become pregnant for the duration of the study, including the post-treatment follow-up period Women and male participants of reproductive potential must agree to use adequate contraception for the duration of the study Evidence of another active pulmonary disorder such as bronchiectasis or chronic obstructive pulmonary disease (COPD) Unable to perform acceptable, repeatable spirometry History of myocardial infarction, congestive heart failure, or uncontrolled cardiac arrhythmia within 3 months of screening visit Major surgical procedure(s) within 4 weeks of screening visit Blood donation within 2 weeks of screening visit Treatment in an emergency room for asthma (within 4 weeks) or hospitalization for asthma or respiratory condition within 2 months of screening visit Evidence of active sinus disease within 2 weeks of screening visit Upper respiratory infection (viral or bacterial) within 1 month of screening visit History of a psychiatric disorder within 3 months of screening visit History of human immunodeficiency virus (HIV)
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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, Chronic Obstructive Pulmonary Disease Dyspnea years of age or older Physician diagnosed COPD confirmed by spirometry with the most recent result available defined as a prior post-bronchodilator FEV1/FVC < 0.7 in accordance with the GOLD 2014 criteria Respiratory physician confirmed optimisation of treatment of COPD On stable medications relating to the optimal treatment of COPD or its symptomatic management over the prior week except routine "as needed" medications Breathlessness of a level three (3) or four (4) on the modified Medical Research Council (mMRC) breathlessness scale worst breathlessness intensity in the previous 24 hours was at least 3/10 on a 0-10 numerical rating scale (NRS) English speaking with sufficient reading and writing ability to complete the study questionnaires Assessed as competent (using St Louise University Mental Status Examination (SLUMS) score of 27/30 for people whose highest level of education was high school, and 25/30 for people who did not complete high school) Able and willing to give written informed consent On any opioid for breathlessness in the previous seven (7) days On regularly prescribed opioid medications for other conditions, including codeine preparations at or above 8mg oral morphine equivalent daily dose (MEDD) in the previous seven (7) days History of adverse reactions to any of the study medications or constituents in the placebo Australian-modified Karnofsky performance score (AKPS) less than 50 at the beginning of the study Respiratory or cardiac event in the previous one week (excluding upper respiratory tract infections). Illness must have resolved completely prior to baseline evaluation, as judged by the person's treating physician Evidence of respiratory depression with resting respiratory rate <8/min Documented central hypoventilation syndrome Current history of abuse of alcohol, or recent history of substance misuse Uncontrolled nausea, vomiting or evidence of a gastrointestinal tract obstruction Renal dysfunction with creatinine clearance calculated (MDRD) less than 20 mls/minute
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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): 12.0-50.0, Asthma Informed consent: Subjects must give their signed and dated written informed consent to participate prior to commencing any study related activities Age Range: 12 to 50 years of age, inclusive, at Visit 1 (Screening) Diagnosis: A diagnosis of asthma, as defined by the National Institutes of Health for at least 12 weeks prior to Visit 1 Asthma Severity: Subjects must have a pre-bronchodilator FEV1 of >=70 percent of the predicted normal value. Predicted values will be based upon Global Lung Function Initiative equations for spirometry reference values Evidence of EIB: Subjects must answer "Yes" to at least 2 of the following 3 questions reflecting on the previous 12 months Are you short of breath during exercise or other physical exertion? Do you wheeze after exercise or other physical exertion? Do you cough after exercise or other physical exertion? Concurrent Anti-Asthma Therapy: Subjects must be taking low to moderate dose inhaled steroids for 12 weeks prior to Visit 1 in order to participate with no change in dose for the 4 weeks prior to Visit 1 Intermittent Asthma, Seasonal Asthma, or Exercise-Induced Bronchoconstriction Only: Subjects with only intermittent or seasonal asthma or only exercise-induced asthma are excluded from participation in this study History of Life-threatening Asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures within the last 10 years Asthma Exacerbation: Any asthma exacerbation requiring oral corticosteroids within 12 weeks of Visit 1 or that resulted in an overnight hospitalization requiring additional treatment for asthma within 6 months prior to Visit 1 Symptomatic Allergic Rhinitis: Subjects with symptomatic allergic rhinitis at Visit 1 may be treated for up to four weeks with intranasal corticosteroids followed by a repeat screening visit to determine prior to entry into the study. Subjects that continue to be symptomatic after up to four weeks of treatment will be excluded Lead Electrocardiogram (ECG): A subject is not eligible if he/she has an abnormal, clinically significant ECG as determined by the investigator at the Screening Visit Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1 and led to a change in asthma management or, in the opinion of the investigator, is expected to affect the subject's asthma status or the subject's ability to participate in the study Concurrent Respiratory Disease: A subject must not have current evidence of: 1. Atelectasis 2. Bronchopulmonary dysplasia 3. Chronic bronchitis 4. Chronic obstructive pulmonary disease (COPD) (current or past diagnosis including asthma/COPD overlap) 5. Pneumonia 6. Pneumothorax 7. Interstitial lung disease 8. Or any evidence of concurrent respiratory disease other than asthma Other Concurrent Diseases/Abnormalities: A subject must not have any clinically significant, uncontrolled condition, or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study Investigational Medications: A subject must not have used any investigational drug within 30 days prior to Visit 1 or within five half-lives (t1/2) of the prior investigational study, whichever is longer of the two periods
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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): 18.0-100.0, COPD have severe/very severe COPD diagnosis have had chronic respiratory insufficiency for at least 3 months and be in steady oxygen therapy (LTOT) with a minimal supplement of 1 litre of oxygen per minute for at least 16 hours per day understand and accept oral and written information in Danish be capable of handling the Airvo warm humidifier after instruction Comorbidity (known malignant disease, terminal illness, dementia, uncontrolled mental illness) Bronchiectasis without simultaneous COPD diagnosis Treatment with BiPAP in the home Affected level of consciousness Smoking status change during project period
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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, Corticosteroid Resistant (CR) Asthmatics Asthmatic Subjects Males and women of non-childbearing potential aged 18-65 of any racial or ethnic background, who are physically and mentally able to cooperate with the proposed tests and procedures and who are able to give informed consent Asthma defined by symptoms and/or a doctor's diagnosis compatible with asthma as per 2014 GINA Guidelines Symptomatic patients (ACQ>1.25) with FEV1 % predicted 80%, currently taking ICS or ICS/LABA. Patients should demonstrate normal bronchodilator response, i.e. there must be equal or greater than 12% or 200ml improvement in FEV1 post-bronchodilator (albuterol) Females must have a negative pregnancy test at Visit 1, must not be lactating and must be of non-childbearing potential, by fulfilling one of the following Postmenopausal defined as amenorrhoea for at least 12 months or more following cessation of all possible exogenous hormonal treatments and luteinising hormone (LH) and follicle-stimulating hormone (FSH) levels in the postmenopausal range (at Visit 1) Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation Males must be surgically sterile or agree to use an acceptable method of contraception (defined as barrier methods in conjunction with spermicides) for the duration of the study (from the time they sign consent) and for 3 months after the last dose of investigational product to prevent pregnancy in a partner A weight of ≥50 kg (measured at Visit 1) Healthy Controls Subjects must be 18 to 65 years old, who are physically and mentally able to cooperate with the proposed tests and procedures and who are able to give informed consent An FEVl <60% predicted post albuterol bronchodilator Oral steroid use within the past 6 weeks Acute respiratory illness within 6 weeks of the study Another pulmonary disease expected to affect participation in the study or the measurements to be examined Pregnancy Smoking in last year or prior smoking history of more than 10 pack years Previous randomization to treatment in the present study (at Visit 1) Participation in another clinical study with any novel investigational medicine product within 3 months before the first dose of investigational product in this study (at Visit 4) Previously intake of any p38 inhibitor (same class as AZD7624) Significant disease or disorder other than asthma (e.g. cardiovascular; pulmonary as e.g. tuberculosis and cystic fibrosis; gastrointestinal, liver; neurological; musculoskeletal; endocrine; metabolic; malignant; psychiatric; major physical impairment) which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study (at Visit 1)
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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 Key Confirmed diagnosis of CF as determined by the 2008 Cystic Fibrosis Foundation Consensus Report Must have a body weight of > 40 kg (88.2 lb) at study screening Pre-bronchodilator FEV1 ≥ 40% and ≤ 80% of predicted at screening Two pre-bronchodilator spirometry measures during screening and baseline must meet the following 2 The relative difference of FEV1(L), calculated as the absolute value of [(first FEV1 second FEV1) / first FEV1] x 100 should be < 12% AND The absolute difference in FEV1 should be < 200 ml Negative Sputum Investigation/History of any Mycobacterium spp. or Burkholderia spp. per specified protocol-defined time periods Clinically stable with no evidence of significant respiratory symptoms that would require administration of IV antibiotics, oxygen supplementation, or hospitalization within 30 days of baseline Concurrent use of oral antibiotics (excluding chronic azithromycin use) or IV antibiotics within 30 days of baseline. Prophylactic and chronic doxycycline use is prohibited during the study Hospitalization for a respiratory event within 30 days of baseline Current use of systemic immunosuppressive drugs including oral corticosteroids within 30 days of Baseline Current requirement for daily continuous oxygen supplementation or requirement (medically necessary) of more than 2 L/minute at night (subject would not meet this criterion if supplemental oxygen is used for comfort only) History of solid organ (including lung) or hematologic transplant, or currently on a transplant waiting list Note: Other protocol defined Inclusion/
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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 Rhinoconjunctivitis Asthma Patients aged 18 years or older; 2. Patients with at least 2 years history of SARC prior to the study and mild to moderate asthma (GINA 2 and 3) inadequately controlled on inhaled corticosteroids and in whom "as-needed" short acting beta-agonists provide inadequate clinical control; 3. Forced expiratory volume at one second (FEV1) > 70% of the predicted normal value demonstrable at least 6 hours after last short acting β-2 agonist use or 12 hours after last long acting β-2 agonist (LABA) use; 4. Nasal Symptoms Score (NSS) at baseline ≥ 3. Baseline NSS will be defined as the mean of the 6 last assessments of the patients' diary (3 last days before randomization); 5. Positive results of skin prick test on at least one seasonal allergen within the last 3 years; 6. Patients who provided a signed written informed consent form; 7. Patients who are able and willing to complete web-based Patient's Diary; 8. Patients who agree to maintain consistency in their surroundings throughout the study period; 9. Women of childbearing potential (WOCBP) including peri-menopausal women who have had a menstrual period within 1 year have to have a negative pregnancy test. Results have to be available until the Visit 2 and negative for the patient to be entered in the study. 10. WOCBP have to use an effective method of birth control throughout the study period and for 4 weeks after study completion (defined as a method which results in a failure rate of less than 1% per year) such as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) intrauterine device (IUD) intrauterine hormone-releasing system (IUS) bilateral tubal occlusion vasectomised partner (provided that partner is the sole sexual partner of the trial participant and that the vasectomised partner has received medical assessment of the surgical success) sexual abstinence In each case of delayed menstrual period (over one month between menstruations) confirmation of absence of pregnancy is strongly recommended. This recommendation also applies to WOCBP with infrequent or irregular menstrual cycles Patients with hypersensitivity to any component of the study medications; 2. Patients with non-allergic rhinoconjunctivitis (e.g. vasomotor, infectious, drug-induced); 3. Presence of nasal polyps or any clinically important nasal anomaly; 4. History of acute and/or chronic sinusitis within 30 days of Visit 2; 5. History of eye surgery within 3 months of Visit 2; 6. History of intranasal surgery within 3 months of Visit 2; 7. Immunotherapy within 6 months prior to Visit 1; 8. Upper respiratory infections including cold and systemic infections within 3 weeks of Visit 2; 9. Patients with moderate to severe renal impairment and taking P-gp inhibitors (e.g. ketoconazole, erythromycin, cyclosporine, ritonavir, diltiazem) within 7 days prior to the first dose of study medication; 10. Patients requiring daily "controller" medications with cromolyn-type drugs or leukotriene antagonists; 11. Patient required daily "controller" medication with Inhaled corticosteroids (ICS) or LABA at medium /high dosage defined by GINA criteria; 12. Patients with clinically important (based on principal investigator's judgment) hepatic impairment; 13. Patients with severe concomitant disease (based on principal investigator's judgment) that could interfere with treatment response; 14. Patients with QT syndrome; 15. Patients with Galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption; 16. Pregnant or breast-feeding women; 17. Patients with a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study (based on principal investigator's judgment); 18. Patients who had a recent history (within previous 12 months) of drug addiction or alcohol abuse based on Principal investigator's judgment ; 19. Patients participating in or having participated in another clinical trial within the previous three months; 20. Patients unable to take relief medications due to contraindications or intolerance; 21. Patients who are taking or have taken any of the following medications prior to randomisation in the study and have not complied with the specified washout period Antihistaminic drugs or montelukast (7 days) Systemic or intranasal corticosteroids (4 weeks) Delayed-release corticosteroids (3 months) Ketotifen (2 weeks) Macrolides antibiotics and imidazolic antifungals (systemic)(7 days) Anticholinergics (7 days) Drugs with antihistamine properties (phenothiazine) (7 days) Intranasal and systemic decongestants (3 days)
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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, Osteoarthritis Patients diagnosed with Glenohumeral Osteoarthritis undergoing total shoulder arthroplasty Patients undergoing total shoulder arthroplasty following trauma, failed prior surgery/revision or infection
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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 Provision of informed consent before any study specific procedures. 2. Men or non-pregnant, non-lactating women 18 to 75 years of age, inclusive. 3. Non-smoker or ex-smoker (quit ≥6months prior to Visit 1) with a total smoking history of ≤10 pack years. 4. Documented clinical diagnosis of asthma for ≥6 months before Visit 1 according to GINA guidelines. 5. On stable dose of ICS or ICS/LABA FDC, for at least 1 month prior to Visit 1, at the doses approved in the country of enrolment. 6. Prebronchodilator FEV1 at Visit 2 ≥40% and ≤85% of predicted (1 repetition of the test is allowed before screen failure). 7. Reversibility to salbutamol (per American Thoracic Society (ATS)/European Respiratory Society (ERS) 2005 ie, ≥12% and ≥200 mL) at Visit 2 (1 repetition of the test is allowed before screen failure). 8. Demonstrate the ability to use the study inhalation device properly. 9. Able to perform repeated pulmonary function testing for FEV1. 10. Able to read, speak and understand German. 11. Patient must agree to all restrictions during the study Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). 2. Participation in another clinical study with an IP during the last 3 months. 3. Known or suspected hypersensitivity to the IP or excipients, including lactose (Note: lactose intolerance is not an exclusion). 4. Systemic steroid use in the 6 weeks before Visit 1. 5. Hospitalization due to asthma in the 6 months prior to Visit 1. 6. Any active pulmonary disease other than asthma. 7. Non-compliance with study procedures in the run in period as judged by the Investigator. 8. Treatment with biologicals such as monoclonal antibodies or chimeric biomolecules including omalizumab within 6 months or 5 half-lives before Visit 1 (whichever is longer). 9. Treatment with any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to Visit 1. 10. Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to Visit 1. 11. Any laboratory abnormality or suspicion of any clinically relevant disease or disorder (on history or examination), including uncontrolled hypertension or uncontrolled diabetes, which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study, or any other safety concerns in the opinion of the Investigator. 12. Known chronic hepatitis or HIV infections at the time of enrolment. 13. Any active malignancy or treatment thereof within the 3 years prior to enrolment. 14. Any clinically important abnormalities in rhythm, conduction, or morphology of the screening 12-lead ECG as judged by the Investigator on the screening ECG. 15. Prolonged QT interval using Fridericia's correction 450 msec for males and 470 msec for females on the screening ECG or family history of long QT syndrome. 16. PR (PQ) interval prolongation (> 240 msec), intermittent second or third degree atrialventricular (AV) block or AV dissociation on the screening ECG. 17. Implantable cardiac defibrillator and patients with sustained symptomatic ventricular and/or atrial tachyarrhythmia. 18. Any contraindication against the use of sympathomimetic drugs as judged by the Investigator. 19. Unstable angina pectoris or stable angina pectoris classified higher than Canadian Cardiovascular Society Class II, or a myocardial infarction, or stroke within 6 months before Visit 1. 20. History of hospitalisation within 12 months caused by heart failure or a diagnosis of heart failure higher than New York Heart Association Class II. 21. Suspected poor capability to follow instructions of the study, as judged by the Investigator. 22. History of or current alcohol or drug abuse (including marijuana), as judged by the Investigator. 23. Planned in-patient surgery, major dental procedure or hospitalisation during the study. 24. Involvement in the planning and/or conduct of the study (applies to AstraZeneca staff, contract research organisation staff and/or staff at the study site). 25. Vulnerable persons (eg, persons kept in detention). 26 Daily rescue medication (salbutamol) use of ≥ 12 puffs for ≥ 3 consecutive days during the run-in period. 27. Patient who intends to use any concomitant medication not permitted by this protocol or not to meet the restrictions. 28. Patient on treatment with strong CYP3A4 inhibitors such as ketoconazole or itraconazole or CYP3A4 inducers such as rifampin at Visit 1. 29. Procedures for withdrawal of incorrectly enrolled patients
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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, Liver Injury Hepatitis B Virus Infection History patients with CHD receive long-term statin treatment ALT is over ULN at baseline infection of Hepatitis A Virus, Hepatitis C Virus or Hepatitis E Virus triglyceride is over 4.5 mmol/L decompensated liver cirrhosis (Child B or C) active stage of HBV infection of Burkitt's lymphoma virus or cytomegalovirus, or other acute infectious disease congestive heart failure malignant tumor autoimmune disease receive other potential hepatotoxicity drugs such as immunosuppressant, antituberculotic and non-steroid anti-inflammatory drug
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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, Aspirin-Induced History of asthma History of nasal polyposis History of at least one clinical reaction to oral aspirin or other nonselective COX inhibitor with features of both lower (cough, chest tightness, wheezing, dyspnea) and upper (rhinorrhea, sneezing, nasal obstruction, conjunctival itching and discharge) airway involvement Stable asthma (post-bronchodilator FEV1 of ≥70%, no use of oral or systemic steroids for at least 1 month, and no hospitalizations or emergency room visits for asthma for the prior 6 months) at the time of entry into the study Currently taking montelukast as part of standard asthma treatment for at least 4 weeks before the V1 visit Pregnancy or current breastfeeding History of bleeding diathesis or use of anticoagulant or antiplatelet drugs History of thrombocytopenia < 50 x 10^9/L Hypersensitivity to montelukast Peptic ulcer disease Unstable asthma (post-bronchodilator FEV1 of less than 70%, use of oral or systemic steroids for at least 1 month prior to visit 1, or hospitalizations or emergency room visits for asthma for the prior 6 months) Use of zileuton (which can mask symptoms of aspirin-induced reaction) within 1 month prior to the V1 visit Age under 18 or over 75 years Current smoking
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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, Chest Pain Dyspnea Syncope Hypotension Chief complaint of chest pain, dyspnea (either sudden onset or increased severity of chronic dyspnea), syncope, or hypotension (systolic blood pressure <100 or shock index [heart rate divided by systolic blood pressure] >1) <18 years old Prisoner or ward of the state Trauma High acuity requiring treatment in resuscitation room Obvious cause of symptoms (e.g. acute GI bleed causing hypotension) Any form of "do not resuscitate" (DNR) order Roomed in hall of emergency department (location not amenable to ultrasound protocol)
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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): 19.0-999.0, Rhinitis, Allergic Asthma Dermatitis, Atopic Urticaria Veterinary researchers attending their annual conference Veterinary researchers who receive medication including antihistamine (H1 and H2 blocker), systemic glucocorticosteroid which can effect on the result of skin prick test Veterinary researchers who do not want 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): 6.0-60.0, Asthma children from 6 to 12 years or adults aged between 18 and 60 years typical asthma with medical diagnosis severe exacerbation (requiring ≥ 3 days of oral corticosteroids) during the previous 12 months Internet connexion through a private (patient's or parents' patient's if child) smartphone and/or a tablet computer no use of a written actin plan within the last 1 year agreement to have phone calls or email contacts during the 1 year follow-up of the study informed consent given, signed consent affiliation to a social security atypical asthma: isolated cough, exercise respiratory discomfort other respiratory disease (cystic fibrosis, COPD, etc.) Severe heart disease (except high blood pressure) smoking > 15 pack-years asthma requiring regular oral corticosteroids treatment asthma requiring inhaled controller treatment administered via nebulizations performed at home no health insurance coverage sister or brother already included in this study (applies only to children) pregnancy and breastfeeding
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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): 7.0-77.0, Cough Obtaining of informed consent (or informed consent of parents or persons with parental authority) Affiliation to social security Negative answer to all 12 questions of medical questionnaire for child or to all 11 questions of medical questionnaire for adult Normal cardio-respiratory examination Normal electrocardiogram Without spirometry obstructive syndrome (FEV1 > 70% of predicted value and FEV1/FVC >70%) Refusal or impossibility of obtaining informed consent of person or of persons with parental authority)
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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): 1.0-31.0, B Acute Lymphoblastic Leukemia Central Nervous System Leukemia Ph-Like Acute Lymphoblastic Leukemia Testicular Leukemia Patients must be enrolled on APEC14B1 and consented to Screening on the Part A consent form prior to enrollment on AALL1131 White Blood Cell Count (WBC) Age 1-9.99 years: WBC >= 50 000/uL Age 10-30.99 years: Any WBC Age 1-30.99 years: Any WBC with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible Organ function requirements for patients with Ph-like ALL and a predicted TKI-sensitive mutation: patients identified as Ph-like with a TKI-sensitive kinase mutation must have assessment of organ function performed within 3 days of study entry onto the dasatinib arm of AALL1131 With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL1131; patients cannot have secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy; patients receiving prior steroid therapy may be eligible for AALL1131 Patients with BCR-ABL1 fusion are not eligible for post-induction therapy on this study but may be eligible to enroll in a successor Children's Oncology Group (COG) Philadelphia positive (Ph+) ALL trial by day 15 Induction DS HR B-ALL patients with Induction failure or BCR-ABL1 Female patients who are pregnant are ineligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs Lactating females are not eligible unless they have agreed not to breastfeed their infant Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
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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, Femoroacetabular Impingement Patients with symptomatic FAI Clinical and radiographic evidence of FAI Patients able to provide consent to study participation Completion of 6 weeks of physical therapy program Established Osteoarthritis (Kellgren-Lawrence > 3) Minimum joint space > 2 mm as measured on AP radiograph Hip dysplasia (center edge angle < 20° on AP radiograph) Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer or diabetes Patients with ongoing infection including HIV and Hepatitis Patient with history of osteomyelitis/septic arthritis Anticoagulation therapy Patients who are pregnant or breast feeding Patients with systemic, rheumatic or inflammatory disease of the knee or chondrocalcinosis, hemochromatosis, inflammatory arthritis, arthropathy of the knee associated with juxta-articular Paget's disease of the femur or tibia, hemophilic arthropathy, infectious arthritis, Charcot's knee joint, villonodular synovitis, and synovial chondromatosis Patients taking immunosuppressant medication
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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, Heart Failure With Normal Ejection Fraction Preserved left ventricular systolic function on echocardiography (LVEF>50%) Evidence of diastolic dysfunction by echocardiography (E/e'>15) Symptoms of heart failure NT-proBNP levels >300 pg/ml absence of permanent atrial fibrillation acute multi-organ failure history of any malignant disease within 5 years diminished functional capacity due to non-cardiac co-morbidities (COPD, PAOD, morbid obesity) pregnancy
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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): 15.0-75.0, Bronchial Asthma aged 15-75 2. first diagnosed corresponding to the diagnostic standards established by Asthma Committee, Respiratory Society, Chinese Medical Association, or previously diagnosed asthma without regular treatment 3. Mch bronchial provocation test is positive 4. the chest X-ray is normal accompanied by other disease of respiratory system 2. combined with serious illness of other system, such as myocardial infarction, severe arrhythmia, malignant tumors and so on 3. women with pregnancy or lactation
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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, Coronary Heart Disease The coronary artery disease was defined by one of the following criteria-(1) based on World Health Organization in terms of elevations of cardiac enzymes, electrocardiography (ECG) and clinical symptoms (angina, chest pressure, or shortness of breath); (2) angiographic evidence of more than 50% stenosis in one or more major coronary arteries; (3) previous history of PCI (percutaneous coronary intervention) or CABG (coronary artery bypass graft). The controls were selected from the two medical centers meeting the following (1) with no family history for CAD; (2) no clinical symptoms for CAD; (3) resting ECG showed normal results. The subjects with two or more risk factors of CAD (age>45 for man and >55 for woman, hypertension, diabetes, overweight, hyperlipidemia) were subjected to treadmill stress test and selected as controls if their ECG were normal without clinical symptoms Those with history of cardiomyopathy, valvular disease, peripheral vascular disease, stroke, severe hepatic and kidney deficiency were excluded in our 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): 18.0-100.0, Valvular Heart Disease Stenosis and Regurgitation (Diagnosis) Presence of aortic stenosis, mitral or aortic regurgitation at the time of an echocardiography at the "Cliniques Universitaires Saint Luc"
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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, Asthma Moderate Asthma Key Body mass index (BMI) of 18 to 32 kg/m2 A diagnosis of moderate asthma (according to GINA 2015) for a period of at least 2 years prior to screening Patient must use a stable medium daily dose level of inhaled corticosteroids (ICS) as defined by GINA guidelines, ie, total daily dose of ICS >400 μg and ≤800 μg/day of budesonide or equivalent for at least 1 month prior to screening and during the study A pre-bronchodilator forced expiratory volume in the first sec (FEV1) ≥60% and ≤90% of the predicted normal values at screening and pre-dose at screening A documented positive response to the reversibility test at the screening, defined as improvement in FEV1 ≥12% and ≥200 mL over baseline after 400 μg salbutamol Pmdi Willing and able to comply with clinic visits and study-related procedures Provide signed informed consent. Key Clinically significant abnormal CBC, clinical chemistry, and urine analysis at screening Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, prior to screening History of life-threatening asthma Occurrence of asthma exacerbations or respiratory tract infections within 4 weeks prior to screening Diagnosis of any other airway/pulmonary disease such as Chronic Obstructive Pulmonary Disease (COPD) as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (GOLD 2016); or other lung diseases (eg, emphysema, idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency or restrictive lung disease) Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 1 month prior to screening Use of oral antibiotics/anti-infectives within 2 weeks prior to screening Known sensitivity to doxycycline or tetracyclines, or to any of the components of the investigational product formulation Recent (within the previous 2 months) bacterial, protozoal, viral, or parasite infection History of tuberculosis or systemic fungal diseases
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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): 2.0-21.0, Acute Lymphoblastic Leukemia B Acute Lymphoblastic Leukemia Mixed Phenotype Acute Leukemia T Acute Lymphoblastic Leukemia For patients enrolled on APEC14B1 prior to enrollment on AALL1631, the required diagnostic bone marrow sample has been fulfilled For patients who have not previously enrolled on APEC14B1 prior to enrollment on AALL1631, a baseline diagnostic sample (or peripheral blood sample with blasts if marrow sample unavailable) must be available to develop an MRD probe In addition, laboratory reports detailing evidence of BCR-ABL1 fusion must be submitted for rapid central review within 72 hours of study enrollment Newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed phenotypic acute leukemia (MPAL meeting 2016 World Health Organization [WHO] definition) with definitive evidence of BCR-ABL1 fusion by karyotype, fluorescence in situ hybridization (FISH) and/or reverse transcriptase (RT)-PCR Patient must have previously started induction therapy, which includes vincristine, a corticosteroid, pegaspargase, with or without anthracycline, and/or other standard cytotoxic chemotherapy Patient has not received more than 14 days of multiagent induction therapy beginning with the first dose of vinCRIStine Patient may have started imatinib prior to study entry but has not received more than 14 days of imatinib Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2 Direct bilirubin =< 2.0 mg/dL Shortening fraction of >= 27% by echocardiogram Known history of chronic myelogenous leukemia (CML) ALL developing after a previous cancer treated with cytotoxic chemotherapy Active, uncontrolled infection, or active systemic illness that requires ongoing vasopressor support or mechanical ventilation Down syndrome Pregnancy and breast feeding Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential Lactating females who plan to breastfeed their infants Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block Prior treatment with dasatinib, or any BCR-ABL1 inhibitor other than imatinib
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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 Chronic Health Behavior The intervention trial will be informed by focus groups Focus Group Adult patients with persistent asthma or loved ones of adult patients with persistent asthma (prescribed ICS regardless of whether they are using ICS or not) receiving care at the participating FQHCs Focus Group Patients with persistent asthma or loved ones of patients with persistent asthma under they age of 18 OR NOT prescribed ICS or NOT receiving care at the participating FQHCs Intervention Patients must be: 1. Adults (18 years of age or older) 2. PCP-diagnosed persistent asthma 3. Currently prescribed ICS 4. Receiving asthma care at participating FQHCs 5. Who screen positive for uncontrolled asthma 6. Have erroneous personal health and/or negative ICS beliefs Intervention Participation in focus groups during the development phase 2. Non-English speaking 3. Serious mental health conditions (e.g., psychosis) that preclude completion of study procedures or confound analyses
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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): 8.0-16.0, Asthma Children aged 8-16 years Patient with severe asthma (maximum expiratory flow <50%) Patient admitted to pediatric emergency Patient who has agreed to participate, as well as the parents or legal guardian Chronic respiratory failure, infectious disease, heart disease Refusal to participate in the study No affiliation to a social security scheme (beneficiary or beneficiary) Immediate intubation
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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): 6.0-18.0, Asthma in Children Age: More than or equal to 6 years old 2. Fulfilling the diagnosis of asthma or cough variant asthma (CVA) based on the guideline of China. 3. The patients cooperated very well with the doctors to perform lung function test. Asthma is defined as fulfilling followings 1-4 or 4 and 5: 1. History of variable respiratory symptoms: wheezing, shortness of breath, chest tightness, and coughing. Symptoms are often worse at night or upon awakening, and often triggered by exercise, laughter, allergens, or cold air, viral infections. 2. At onset, scattered wheeze in the lungs is heard with prolonged expiratory time. 3. The above symptoms and signs were efficient for anti-asthma, or alleviates voluntarily. 4. Exclusive of other diseases with wheezing, shortness of breath, chest tightness, and coughing. 5. If the manifestation is non-typical, fulfilling one of the followings Documented airflow limitation： 1. Positive BD reversibility test: Increase in FEV1 of >12% from baseline, 15 minutes after inhalation of 200-400 μg albuterol; 2. Significantly increased in lung function after anti-inflammatory treatment; 3. Increase in FEV1 of >12%, after 4 to 8 weeks of treatment with inhaled corticosteroids and (or) anti-leukotrienes Positive bronchial challenge test Excessive variability in twice-daily PEF over 2 weeks: Average daily diurnal PEF variability >13%. Cough variant asthma (CVA) is defined as fulfilling following: 1. Cough at least 4 weeks without sputum and wheeze, worsening at night or upon awakening; 2. No symptoms of infection, or no effect on long term antibiotic treatment; 3. The symptoms and signs were efficient for anti-asthma treatment; 4. Exclusive of other diseases causing wheeze; 5. Positive exercise challenge test and (or) average daily diurnal PEF variability >13%; 6. Individual or primary, secondary relatives with allergic history, or positive allergen detection Subject will be excluded if she or he has one of the following: 1. congenital heart disease; 2. heart failure; 3. liver failure or renal insufficiency; 4. kidney disease; 5. connective tissue disease; 6. immunodeficiency; 7. tumor; 8. a history of hypertension or diabetes mellitus
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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): 18.0-25.0, Hamstring Tightness Female student with an age of 18-25 years 2. Body mass index between 18-30 3. Students with reduced hamstring length (hamstring tightness) as defined by the literature (popliteal angle less than 160 degree) Lower limb musculoskeletal pain 2. Abdominal, lower limb and spinal surgery 3. Pregnancy 4. Previous injury or trauma to hamstring muscle, hip, knee And ankle joint 5. Skin allergy, disease or hypersensitivity 6. Low back pain or any neurological impairment in the lower extremity 7. Body mass index above 30 or below 18
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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, Crohn Disease Ulcerative Colitis Intestinal Helminthiasis The included volunteer is a researcher within parasitology with main focus on Trichuris trichiura and Trichiura suis. He planned to infect himself and contacted our department with the purpose of being monitored during this infection for safety (medical supervision) and research reasons. The only clinical criterion for his in the study was that he was healthy
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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 Cough Cough Variant Asthma Individuals aged 18-65 years of age with CVA and individuals with methacholine-induced cough but normal airway sensitivity. The following definitions will be used: 1. CVA: chronic cough (≥8 weeks) is the sole or predominant symptom and positive methacholine challenge (PC20 ≤ 16 mg/mL) and history of cough responding to specific asthma treatment (such as inhaled steroid or 1 week trial of bronchodilator); 2. Methacholine-induced cough but normal airway sensitivity: chronic cough (≥8 weeks) is the sole or predominant symptom and negative methacholine challenges (PC20 > 16 mg/mL) Individuals aged 18-65 years of age with no history of asthma or chronic cough an exacerbation necessitating a change in medication, emergency department visit or hospitalizations within the previous 4 weeks inability to perform acceptable spirometry medical contraindications to methacholine challenge testing smoking history in excess of 10 pack years Note: Previous treatment with inhaled or systemic corticosteroids is not an criterion; medication use will be recorded and examined in the analysis
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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): 2.0-18.0, Reactive Airway Disease Wheezing All children having chest wheezes, aged from two years to eighteen years, attending emergency unit of Assiut University Pediatric Hospital, during the period 1⁄6∕2017 to 1∕6⁄2018. They will be examined in Otolaryngology Department, Assiut University Hospital Refusal of endoscopic nasal examination by care givers.and patients with definite diagnosis of wheeze (bronchiolitis,pneumonia)
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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 No upper or lower respiratory infection within 4 weeks Either Negative evaluation for Asthma; no symptoms of disease or no evidence of asthma based on spirometry and/or methacholine challenge test GERD: no symptoms of acid reflux disease or negative potential of hydrogen (pH) probe Rhinosinusitis/upper airway cough Or Cough persists despite treatment for the following Asthma -treated for at least 8 weeks with at least medium dose inhaled corticosteroids or with oral corticosteroids GERD treated for at least 8 weeks with either a proton pump inhibitor (PPI) or H2 blocker Marijuana use (smoking or ingestion of marijuana) in the past 6 months Use of ACE inhibitor currently or within the past 6 weeks Use of zinc supplements or multivitamins containing zinc currently or within the past 6 weeks Occupational exposure to dust or chemicals that may cause cough, as determined by study physician Diagnosis or evidence of chronic obstructive pulmonary disease (COPD) as defined by forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) < 0.70 and FEV1% predicted < 80% History of lung disease, such as Bronchiectasis Interstitial lung disease Sarcoidosis Pneumoconiosis
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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): 40.0-65.0, Asthma for all subjects Age between 40 and 65 years old Smoking history ≤ 10 packyears. for all asthmatics and asthma remission subjects: • Development of asthma symptoms before 21 years. Specific for the 4 different groups Group 1. Subjects with clinical asthma remission Documented history of asthma diagnosed according to latest GINA guidelines, i.e. respiratory symptoms and either bronchodilator reversibility (improvement in FEV1 of more than 12% of baseline (and at least 200 mL) after inhalation of 800 µg salbutamol No use of asthma medications such as inhaled or oral corticosteroids, β2-agonists or anticholinergic in the last 3 years No symptoms of wheeze or asthma attacks during the last 3 years Group 2. Subjects with complete asthma remission Documented history of asthma diagnosed according to latest GINA guidelines, i.e. respiratory symptoms and either bronchodilator reversibility (improvement in FEV1 of more than 12% of baseline (and at least 200 mL) after inhalation of 800 µg salbutamol No use of asthma medications such as inhaled or oral corticosteroids, β2-agonists or anticholinergics in the last 3 years
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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): 21.0-65.0, Stroke Chest Wall Disorder Quality of Life Have clinical diagnosis of ischemic or hemorrhagic stroke primary for more than six months resulting in hemiparesis Have mental competence assessed through the Mini-Exam of the Mental State-MMSE Be able to walk 10 meters independently, with or without assistive device Absence of other neurological or orthopedic deficiencies unrelated to stroke Without report of associated pulmonary pathology and not be smoker or ex-smoker
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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, Chronic Lung Disease Chronic airways diseases as chronic obstructive pulmonary disease, bronchial asthma, bronchiectasis Diabetes Mellitus and Hypertension Cardiac diseases Chronic renal and liver diseases
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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, Hypoxia Patient is willing to give written informed consent Patient can read and comprehend English Patient is ≥ 18 years of age Patient has moderate to severe hypoxaemia (SpO2 ≤ 92%) at rest Patient reports shortness of breath on exertion Patient has musculoskeletal impairment, or other impairment that may be the limiting factor in 6MWT Patient has a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study Patient has acute coronary syndrome, acute myo or pericarditis, acute lung embolism, pulmonary infarction, acute uncontrolled heart insufficiency Patient shows signs of acute exacerbation of underlying lung condition Patient is deemed to be unsuitable for in the opinion of the researcher, including for the following reasons they do not comprehend English they are unable to provide written informed consent they are physically unable to comply with the protocol
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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): 1.0-17.0, Bronchial Asthma children with acute asthma exacerbation children with acute asthma aged 1-17 years old background history of asthma this study will deal with the protocols applied in Assiut university children hospital children below age of 1 year and more than 17 years old Known Tuberculosis exposure concurrent stridor use of oral corticosteroids in the previous four weeks Significant co-morbid disease : lung ,cardiac ,immune , liver , endocrine ,neurological or psychiatric children with other causes of respiratory distress Children with mild or controlled 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, Lung Cancer A diagnosis of lung cancer primary tumour, secondary tumour or mesothelioma 2. Suffering from refractory breathlessness or cough or fatigue (presence of a minimum of two of the three symptoms), and which is bothersome to the patient (see below)* 3. In the presence of COPD, in stable condition 4. WHO Performance Status 0-2 5. Expected prognosis of at least 3 months 6. 18+ years 7. able to give informed consent Patients will be asked as part of the symptom screening process: Are you affected in your day to day life by breathlessness? Are you affected in your day to day life by cough? Are you affected in your day to day life by fatigue? Patients who are experiencing breathlessness, cough and/or fatigue but do not find these symptoms bothersome are not eligible (see below)* 2. Acute exacerbation** of COPD, or chest infection, within the past 3 weeks, necessitating a change in medication 3. Rapidly worsening breathlessness requiring urgent medical intervention 4. Post chemotherapy and/or radiotherapy to the chest > 2 weeks 5. Surgical treatment for lung cancer > 4 weeks Patients will be asked as part of the symptom screening process: Are you affected in your day to day life by breathlessness? Are you affected in your day to day life by cough? Are you affected in your day to day life by fatigue? ** An exacerbation is defined as a sustained worsening of the patient's symptoms from their usual stable state which is beyond normal day-to-day variations, and is acute in onset. Commonly reported symptoms are worsening breathlessness, cough, increased sputum production and change in sputum colour. The change in these symptoms often necessitates a change in medication. NICE guidelines 201025. In this trial, patients will only be excluded if a change in medications were required i.e. steroids or antibiotics
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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): 14.0-80.0, Asthma Chest Syndrome Clinical Anxiety Clinical Depression Lung Function Quality of Life Eosinophilia Nitric Oxide Airway Responsiveness Induced Sputum all subjects agreed to participate, understand the project, observe the use of drugs, agree to follow-up, and signed informed consent; 2. the age of more than 14 and less 80 years old, gender and ethnicity are not limited; 3. the duration time was more than 6 months,and chest tightness was the only complaint, without breathing, short of breath, chronic cough; 4. no wheezing; 5. a diagnosis of asthma supported by one or more other characteristics bronchial provocation test positive improvement in forced expiratory volume at one second (FEV1) of more than 12% and 200 mL after inhaled salbutamol variability in diurnal peak expiratory flow (PEF) of more than 10% for one day during one week. 6. bronchodilator and glucocorticoid treatment is effective; 7. the following diseases by the corresponding doctors: coronary heart disease, myocarditis, heart failure, GERD, neuromuscular disease, and mental disease can not cooperate with related inspection or for other reasons; 2. patients with chronic obstructive pulmonary disease, interstitial pneumonia, active tuberculosis, community acquired pneumonia, lung cancer, bronchiectasis, cor pulmonale, pulmonary embolism, and accompanied with serious systematic disease (such as coronary heart disease, myocarditis, heart failure, gastroesophageal reflux disease, neuromuscular disease, etc); 3. history of drug abuse, alcohol abuse or anesthesia or with a history of mental illness (schizophrenia, obsessive-compulsive disorder, depression) and against personality, motivation, suspicious, or other emotional or mental issues that may affect participation in the study; 4. taking part in other drug clinical trial project, or drop out less than 3 months; 5. during pregnancy, lactation women; 6. obvious abnormal of High Resolution CT
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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, COPD patients with COPD 2. age 8 and 75 (both included) 3. index BODE's 3-7 ( BODE Iindex for Body-mass index, airflow Obstruction, Dyspnea, and Exercise) 4. clinical stability, understood as not having an exacerbation (*) of the COPD and do not require treatment with antibiotics, corticoids systemic and/or hospitalization, at least in the 30 days prior to their 5. has given his consent 6. capable of using technology 7. the subject is willing and is able to meet all the requirements of the study. * Exacerbation : Exacerbation means worsening of two or more of the following main symptoms for at least 2 consecutive days: dyspnea, volume of sputum; Sputum purulence o worsening of any main symptom along with one of the following symptoms for at least 2 consecutive days: sore throat; Cold ( nasal congestion); Fever without any other cause; Cough; Wheezing Osteo-muscular pathology that limit or preclude the exercises 2. Presence of heart disease which limit exercise program 3. patients with bronchiectasis or other several of COPD respiratory disorders 4. comorbidity that prevent respiratory rehabilitation of maintenance program 5. less than 2 years life expectancy 6. any unstable medical or psychiatric process or substance abuse which, in the opinion of the investigator, would affect the ability of the patient to complete the study or impede their participation in 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): 5.0-11.0, Asthma Parent/Guardian/Participant is willing and able to give informed consent/assent Physician-diagnosed asthma that is inadequately controlled as per view of doctor (for example, history of at least two emergency visits to GP or hospital over the previous year, frequent use of blue inhaler (three times or more per week)) Aged 5-11 years (inclusive) Children who are already on at least 400 micrograms per day inhaled beclomethasone or equivalent and hence ready to be prescribed inhaled long-acting beta2 agonists and/or other add-on medication or are already on inhaled long-acting beta2 agonists and/or other add-on medication Parent/Guardian/Participant is unwilling or unable to give informed consent/assent Known contraindication to montelukast or salmeterol Other known significant airway or lung disease (e.g. chronic lung disease of prematurity, cystic fibrosis or congenital airway abnormalities) or other co-existing serious disease such as congenital cardiac disease Poor inhaler technique and/or history of poor adherence on checking following standard procedure at the clinic Participating in another clinical trial (other than observational trials and registries) concurrently or within 30 days prior to screening for entry into 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): 18.0-80.0, Asthma Late-Onset Asthma Childhood Asthma Asthma patients Age between 18-80 years Smoking history of < 10 packyears (PY) Willing and able to comply with the study protocol Asthma diagnosis is based on presence of typical clinical symptoms, reversible airway obstruction (+12% improvement in forced expiratory volume at one second (FEV1) after bronchodilator) or bronchial hyperreactivity (PC20 < 8 mg/ml) or a (fractional exhaled nitric oxide) FeNO > 50 ppb All asthma patients have (Global Initiative for Asthma ) GINA step 4-5 medication (high dose ICS/LABA) Asthma control questionaire (ACQ) > 0,75 Written informed consent. Healthy controls:\Inclusion healthy control Written informed consent Age between 18-80 years Smoking history of > 10 PY Age < 18 years or > 80 years Not able to speak or write Dutch language Not able to perform lung function test/sputum induction ACQ < 0,75 Other diseases which could influence pulmonary function and/or the immune system such as: o A possible infection of the upper or lower respiratory tract 4 weeks prior to the collection of materials Chronic obstructive pulmonary disorder (COPD) in the medical history Auto-immune diseases such as systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), myasthenia gravis or Goodpasture's syndrome Malignancies
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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 Study applicant(s) that fulfill all of the and none of the are eligible for the study- Participant and/or parent guardian must be able to understand and provide informed consent and age-appropriate assent Must have a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the study's Manual of Procedures (MOP) Has had a diagnosis of asthma made >1 year prior to recruitment; --Those who received an asthma diagnosis by a clinician ≤1 year prior to recruitment must report that their respiratory symptoms were present for more than 1 year prior to recruitment Has had ≥2 asthma exacerbations in the prior year (defined as a requirement for systemic corticosteroids and/or hospitalization) At Visit 0 (Screening), has the following requirement for asthma controller medication For those ages 6 to 11 years, treatments with at least fluticasone 250 mcg dry powder inhaler (DPI) one puff twice daily or its equivalent and For those ≥12 years of age, treatment with at least Advair 250/50 mcg dry powder inhaler (DPI), one puff twice daily or its equivalent Has peripheral blood eosinophils ≥150 cells/µl obtained at Visit 0 (Screening) or in another Inner-City Asthma Consortium (ICAC) clinical research study within 6 months Is able to perform spirometry at randomization (Visit for treatment assignment) Individual(s) who meets any of the following are not eligible for enrollment or randomization- Is not able or willing to give written informed consent or comply with the study protocol Has concurrent (existing) medical problems that would require systemic corticosteroids or other immunomodulator treatments during the study Is currently receiving immunotherapy Is currently receiving treatment with omalizumab or has had omalizumab treatment within 6 months prior to planned participant randomization to treatment assignment Is currently requiring greater than fluticasone 500 mcg administered twice daily plus a long-acting beta agonist (LABA) one puff twice daily or its equivalent, and/or --Individuals using oral corticosteroids daily or every other day for more than 14 days at the time of Visit 0 (Screening) Is currently pregnant or lactating, or plans to become pregnant during the time of study participation --Note: Females of child-bearing potential (post-menarche) must be abstinent or use a medically acceptable birth control method throughout the study (e.g. oral subcutaneous, mechanical, or surgical contraception) Has a known, pre-existing clinically important lung condition other than asthma Has a current malignancy or previous history of cancer in remission for less than 12 months prior to randomization Has known, pre-existing, unstable liver disease
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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, Bronchial Asthma Patient diagnosed with chronic persistent asthma Annual uncontrollable time ≥ 3 months Patients who have given written informed consent History of upper upper/lower respiratory infection in the previous 1 months History of long-term controller medication use for asthma (oral corticosteroid or intravenous corticosteroids therapy) within the preceding 1 months History of antibiotic use in the previous 1 months History of life-threatening asthma History of chronic lung diseases other than asthma, including but not limited to chronic obstructive pulmonary disease, bronchiectasis, emphysema, tuberculosis, sarcoidosis, pulmonary fibrosis, lung cancer, etc History of serious disease of the heart and cerebrovascular disease History of severe liver or renal dysfunction or disease History of severe disease in the hematopoietic system History of immunodeficiency (including, but not limited to, HIV positive detection, or other acquired or congenital immunodeficiency disease, or organ transplant history) History of any other condition (such as known drug or alcohol abuse or psychiatric disorder) which, in the opinion of the investigator, may preclude the patient from following and completing the protocol
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1
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