Bronchial thermoplasty has been studied in a rigorous, stepwise fashion beginning with animal studies, followed by four clinical studies in asthma patients, three of which were randomized controlled clinical trials. Click on the individual trial name below for additional information on each clinical study.
|
(Study Title) Trial Name |
Study Description | No. of Patients | Key Findings |
|---|---|---|---|
| AIR2 Trial | Randomized, double-blind, sham-controlled, pivotal IDE trial to evaluate effectiveness and safety in patients with severe asthma |
190 BT 98 Sham |
Improved AQLQ Reduction in severe exacerbations, ER visits and hospitalizations for respiratory symptoms, days lost from work/school/other daily activities due to asthma No deterioration in FEV1 Stable, long term safety profile No radiological findings of clinical significance observed in high resolution CT scans taken at 1 year. BT provides long term asthma control in patients with severe asthma |
| RISA Trial | Randomized, controlled (standard-of-care) trial designed to evaluate safety and reduction in medications or asthma symptoms in patients with severe, refractory asthma |
15 BT 17 Control |
Strong suggestion of reduction in OCS use in this small sample set Improvements in measures of asthma control (AQLQ, ACQ, FEV1, rescue medication use) No deterioration in FEV1 despite steroid wean Stable, long-term safety profile (3 year follow-up) based on absence of clinical complications and stable FEV1 over a 3-year period |
