At a glance
ClinicalIndex Comparison Record- ✓Age 18–65 years, ambulatory adult
- ✓Asthma on regular maintenance with ICS (≥200 μg beclomethasone/day equivalent) AND LABA (≥100 mg salmeterol/day equivalent)
- ✓Pre-bronchodilator FEV1 60–85%
- ✓PC20 <8 mg/mL on methacholine inhalation test
- ✕Current or recent respiratory tract infection (resolved <6 weeks before pretreatment)
- ✕History of recurrent lower respiratory tract infections (≥3 per year requiring antibiotics)
- ✕Unstable asthma within 6 weeks of enrollment (new/increased maintenance medications, extra healthcare visits, new IV/nebulized medications)
- ✕Post-bronchodilator FEV1 <65%
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicenter Randomized Clinical Trial of the Alair System for the Bronchial Thermoplasty Treatment of Asthma
In Brief
A clinical study evaluating Bronchial thermoplasty with the Alair System and Conventional therapy with ICS+LABA for Asthma. Completed, enrolled 112 participants.
Detailed Summary
The purpose of this study is to demonstrate the effectiveness and safety of the Alair System for the treatment of asthma. This will be a multicenter, randomized controlled study comparing the effects of treatment with the Alair System to standard drug therapy. One-hundred and ten subjects will be randomized 1:1 to either the Alair Group (Medical management + Alair treatment),or Control Group (Medical management only).
Study Details
Timeline
Interventions
Conventional therapy with ICS+LABA plus bronchial thermoplasty with the Alair System.
Conventional therapy with ICS+LABA.