Actively Recruiting
Bronchial Thermoplasty (BT) for Severe Asthma in the Biologic Era: a Randomized Controlled Trial (BOOSTER Trial)
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-12-18
90
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Bronchial Thermoplasty for Adults With Severe Asthma in the Biologic Era
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult (over 18 years old)
- Severe uncontrolled asthma with ACQ above 1.5 despite optimal medical therapy
- One or more trials of biologic treatment or ineligible for biologics
- Two or more severe asthma exacerbations in the previous year requiring oral corticosteroids
- Lung function (FEV1) at or above 50% predicted after bronchodilator use
You will not qualify if you...
- Chronic oral corticosteroid therapy above 20 mg/day prednisone equivalent
- One or more ICU admissions for asthma in the previous year
- Use of anti-coagulation therapy that cannot be temporarily stopped
- Pregnancy
- Body mass index 35 or higher
- Current or former smokers with over 20 pack years
- Lung diffusing capacity (DLCOc) below 70%
- Known sensitivity to medications needed for bronchoscopy
- Use of immunosuppressants other than oral steroids affecting bronchial thermoplasty
- Bleeding disorders or low platelet count below 100,000/mm2
- Comorbidities contraindicating bronchial thermoplasty such as severe heart failure or other serious respiratory diseases
- Use of pacemaker or cardiac defibrillator devices
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 weeks
Participants receive bronchial thermoplasty treatment in three sessions, performed by a pulmonologist under sedation or anesthesia, targeting different lobes of the lungs at three week intervals.
3 treatment visits spaced 3 weeks apart
Duration - 12 months
Participants are monitored for asthma outcomes including exacerbations, quality of life, symptom burden, emergency visits, hospitalizations, and medication use for up to 12 months after treatment.
Regular follow-up visits over 12 months
Trial Site Locations
Total: 2 locations
1
amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
2
UMCG
Groningen, Netherlands
Not Yet Recruiting
Research Team
P
P Bonta, Md PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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