Asthma
Conditions
Keywords
Asthma,, Asthma exacerbation, Bronchial thermoplasty
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).
Interventions
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-65 years * Asthma which requires treatment with guidelines suggested medications for GINA steps 4-5 * Four or more bursts of systemic corticosteroids \>3 days each in the previous year * Willingness and ability to give written informed consent
Exclusion criteria
* Current smoker and former smoker \> 10 pack years total smoking history * Participation in another clinical trial within the prior 4 months * Omalizumab therapy within the prior 4 months * Allergic bronchopulmonary aspergillosis * Patient having had severe exacerbation of their asthma requiring high doses of oral corticosteroids (\> 60 mg equivalent prednisolone) more than one month in the previous year * Post-bronchodilator FEV1 of less than 30% * Past diagnosis of COPD and chronic respiratory insufficiency * Known coagulopathy or platelet dysfunction * Use of anticoagulants * Use of an internal or external pacemaker or internal cardiac defibrillator * Contraindication to perform bronchoscopy * Contraindication to perform general anesthesia * Significant cardiovascular disease * Current or recent respiratory tract infection resolved less than 4 weeks * Known cancer or cancer history less than 12 months * Pregnancy and nursing mother
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Inflammatory cells and markers in induced sputum | Time Frame: Baseline and 12 Months |
| Asthma Control Questionnaire (ACQ) Score | Baseline, 3, 6, 9 and 12 Months |
| Asthma Quality of Life Questionnaire (AQLQ) Score | Baseline, 3, 6, 9 and 12 Months |
| Structural airway remodeling using CT | Baseline and 12 Months |
| Mean oral glucocorticosteroid dose (mg equivalent prednisone) | Baseline, 6 and 12 Months |
| Mild exacerbation rate | Baseline, 6 and 12 Months |
| Pre- and post-bronchodilator FEV1 | Baseline, 6 and 12 Months |
| Time to the first severe asthma exacerbation | anytime |
Countries
France
Outcome results
None listed