Bronchial Thermoplasty in Severe Asthma With Frequent Exacerbations

Study Overview
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Brief Summary
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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).

Official Title
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Bronchial Thermoplasty in Severe Asthma With Frequent Exacerbations

Conditions
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Asthma

Intervention / Treatment
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* Device: Bronchial thermoplasty with the Alair System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thermoplasty group<br>Procedure: Bronchial thermoplasty with the Alair System and conventional therapy | Device: Bronchial thermoplasty with the Alair System<br> <br> |
| No Intervention: Control group<br>Conventional therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe exacerbation rate (change from baseline) | A severe exacerbation is defined by a burst of systemic corticosteroids >3 days | Baseline, 6 months and 12 months after the last thermoplasty procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to the first severe asthma exacerbation |  | anytime | 
| 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 | 
| 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 | 
| Inflammatory cells and markers in induced sputum |  | Time Frame: Baseline and 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma,, Bronchial thermoplasty, Asthma exacerbation