Bronchial Thermoplasty Compared to Standard Care for Adults with Severe Uncontrolled Asthma Despite Biologics

What this Trial Is About

Researchers are evaluating bronchial thermoplasty BT, a non-drug treatment for severe asthma that remains uncontrolled despite optimal medical therapy including biologics. The study aims to compare BT with standard care to assess its impact on asthma exacerbation rates, quality of life, and cost-effectiveness over 1 and 5 years. This investigation addresses the need for effective treatments for patients who do not respond to or are ineligible for biologics, as current options like pulmonary rehabilitation have limited benefits. The study is a randomized, multicenter trial where adult patients with severe uncontrolled asthma receive either BT or standard care. BT involves three sessions spaced three weeks apart, where radiofrequency energy is applied to different lung lobes via bronchoscopy under sedation or anesthesia. The control group continues with usual care. The trial evaluates outcomes over a 12-month follow-up period, with long-term cost-effectiveness also assessed. Participants will undergo evaluations including lung function tests, asthma control questionnaires, and quality of life assessments. Researchers will monitor the rate of severe exacerbations, hospitalizations, emergency visits, and use of oral corticosteroids and biologics. Safety and treatment-related adverse events will be tracked over the study period. The total participation time includes follow-up assessments up to five years for cost-effectiveness analysis.

Bronchial Thermoplasty for Adults With Severe Asthma in the Biologic Era