Bronchial Thermoplasty in Severe Asthma With Frequent Exacerbations
Not Applicable
- Conditions
- Asthma
- Interventions
- Device: Bronchial thermoplasty with the Alair System
- Registration Number
- NCT02464995
- Lead Sponsor
- University Hospital, Strasbourg, France
- Brief Summary
The purpose of this study is to demonstrate the effectiveness of bronchial thermoplasty in a severe asthmatic population with frequent exacerbations.
This will be a single center randomized and controlled study. Thirty subjects with severe asthma (Gina 4 and 5) with frequent severe exacerbations (four or more bursts of systemic corticosteroids \>3 days each in the previous year) will be randomized 1:1 to either the thermoplasty group (bronchial thermoplasty and medical management) or control group (medical management only).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Thermoplasty group Bronchial thermoplasty with the Alair System Procedure: Bronchial thermoplasty with the Alair System and conventional therapy
- Primary Outcome Measures
Name Time Method Severe exacerbation rate (change from baseline) Baseline, 6 months and 12 months after the last thermoplasty procedure A severe exacerbation is defined by a burst of systemic corticosteroids \>3 days
- Secondary Outcome Measures
Name Time Method Mean oral glucocorticosteroid dose (mg equivalent prednisone) Baseline, 6 and 12 Months Pre- and post-bronchodilator FEV1 Baseline, 6 and 12 Months Asthma Quality of Life Questionnaire (AQLQ) Score Baseline, 3, 6, 9 and 12 Months Time to the first severe asthma exacerbation anytime Mild exacerbation rate Baseline, 6 and 12 Months Asthma Control Questionnaire (ACQ) Score Baseline, 3, 6, 9 and 12 Months Structural airway remodeling using CT Baseline and 12 Months Inflammatory cells and markers in induced sputum Time Frame: Baseline and 12 Months
Trial Locations
- Locations (1)
Hôpitaux Universitaires de Strasbourg
🇫🇷Strasbourg, France