At a glance
ClinicalIndex Comparison Record- ✓Age 18–65 years, ambulatory adult
- ✓Asthma on high-dose ICS AND LABA with or without oral prednisone ≤30 mg/day or other asthma maintenance drugs
- ✓Pre-bronchodilator FEV1 ≥50% predicted
- ✓Evidence of airway hyperresponsiveness: PC20 <4 mg/ml (FEV1 ≥60% predicted) OR FEV1 increase ≥12% after short-acting β2 agonist (FEV1 <60% predicted)
- ✕Immunosuppressant therapy (e.g., methotrexate)
- ✕Current or recent lower respiratory tract infection (resolved <6 weeks from testing)
- ✕Recurrent lower respiratory tract infection: >3 in last 3 months
- ✕Other respiratory diseases: emphysema, cystic fibrosis, vocal cord dysfunction, mechanical airway obstruction, obstructive sleep apnea, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicenter Randomized Clinical Trial of Bronchial Thermoplasty With the Alair System for the Treatment of Severe Asthma
In Brief
A clinical study evaluating Bronchial Thermoplasty with the Alair System and Control for Asthma. Completed, enrolled 34 participants.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of the Alair System for the treatment of severe refractory asthma. This will be a multicenter, randomized controlled study comparing the effects of treatment with the Alair System to standard drug therapy in patients with severe asthma refractory to standard medication therapy. A total of 30 subjects will be randomized 1:1 to the Alair Group (Medical management + Alair Treatment) OR the Control Group (Medical management only).
Study Details
Timeline
Interventions
Alair treatment plus standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤ 30 mg/day.
Standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤30 mg/day.