Differences in inclusion and exclusion criteria between the PAS2 (Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma) study and AIR2 (Asthma Intervention Research 2) trial
| PAS2 | AIR2 | |
| Inclusion | Age 18–65 years Able to provide written informed consent Willing and able to comply with study protocol ICS >1000 μg·day−1 (beclomethasone equivalent), LABA ≥80 μg salmeterol or equivalent May also be taking leukotriene modifiers and/or anti-IgE OCS ≤10 mg·day−1 Pre-bronchodilator FEV1 % pred ≥60% Nonsmoker for ≥1 year (if former smoker, <10 pack-years total smoking history) Able to undergo outpatient bronchoscopy procedures Has had at least 2 days of asthma symptoms in the last 4 weeks AQLQ score ≤6.25 during baseline period | Age 18–65 years Able to provide written informed consent Willing and able to comply with study protocol including requirements for taking and abstaining from medications ICS >1000 μg·day−1 (beclomethasone equivalent), LABA ≥100 μg salmeterol or equivalent May also be taking leukotriene modifiers and/or anti-IgE OCS ≤10 mg·day−1 Pre-bronchodilator FEV1 % pred ≥60% Nonsmoker for ≥1 year (if former smoker, <10 pack-years total smoking history) Able to undergo outpatient bronchoscopy procedures Has had at least 2 days of asthma symptoms in the last 4 weeks AQLQ score ≤6.25 during baseline period PC20 <8 mg·mL−1 per methacholine inhalation test using standardised methods |
| Exclusion | Participation in another trial within 6 weeks of baseline period involving respiratory intervention Over the last 7 days of a 4-week medication stable period, rescue medication usage exceeds an average of 8 puffs·day−1 SABA, 4 puffs·day−1 rescue bronchodilator or two nebuliser treatments·day−1 Post-bronchodilator FEV1 % pred <65% History of life-threatening asthma (previous intubation or ICU admission in prior 2 years) ≥4 lower respiratory tract infections in previous 12 months ≥3 hospitalisations for asthma in the previous 12 months ≥4 pulses of systemic corticosteroids in the past 12 months Known sensitivity to medications required to perform bronchoscopy Other respiratory diseases including emphysema, cystic fibrosis, vocal cord dysfunction, mechanical upper airway obstruction, Churg–Strauss syndrome, allergic aspergillosis Segmental atelectasis, lobar consolidation, significant or unstable pulmonary infiltrate, or pneumothorax confirmed by chest radiography Cardiovascular disease including myocardial infarction, angina, cardiac dysfunction, cardiac dysrhythmia, conduction defect, cardiomyopathy or stroke Known aortic aneurysm Significant comorbid illness including cancer, renal failure, liver disease or cerebral vascular disease Uncontrolled hypertension Implanted electrical stimulation device Known coagulopathy Any other medical condition that could interfere with study participation in the opinion of the investigator | Participation in another trial within 6 weeks of baseline period involving respiratory intervention Over the last 7 days of a 4-week medication stable period, rescue medication usage exceeds an average of 8 puffs·day−1 SABA, 4 puffs·day−1 rescue bronchodilator or two nebuliser treatments·day−1 Post-bronchodilator FEV1 % pred <65% History of life-threatening asthma (previous intubation or ICU admission in prior 2 years) ≥4 lower respiratory tract infections in previous 12 months ≥3 hospitalisations for asthma in the previous 12 months ≥4 pulses of systemic corticosteroids in the past 12 months Known sensitivity to medications required to perform bronchoscopy Known systemic hypersensitivity or contraindication to methacholine chloride or other parasympathomimetic agents Undergoing immunosuppressant therapy (i.e. methotrexate) Use of β-adrenergic blocking agents Use of anticoagulant medication Insulin-dependent diabetes Pregnant/nursing mother or plans to become pregnant within the next year Other respiratory diseases including emphysema, cystic fibrosis, vocal cord dysfunction, mechanical upper airway obstruction, obstructive sleep apnoea, Churg–Strauss syndrome, allergic aspergillosis Segmental atelectasis, lobar consolidation, significant or unstable pulmonary infiltrate, or pneumothorax confirmed by chest radiography Interstitial lung disease Chronic sinus disease Uncontrolled gastro-oesophageal reflux disease History of epilepsy Cardiovascular disease including myocardial infarction, angina, cardiac dysfunction, cardiac dysrhythmia, conduction defect, cardiomyopathy or stroke Known aortic aneurysm Significant comorbid illness including cancer, renal failure, liver disease or cerebral vascular disease Uncontrolled hypertension Implanted electrical stimulation device Known coagulopathy Psychiatric or other disorder that could interfere with study participation in the opinion of the investigator |
Differences are indicated in italics. ICS: inhaled corticosteroid; LABA: long-acting β-agonist; OCS: oral corticosteroid; FEV1: forced expiratory volume in 1 s; AQLQ: Asthma Quality of Life Questionnaire; PC20: provocative concentration reducing FEV1 by 20% from baseline; SABA: short-acting β-agonist; ICU: intensive care unit.