THERMASCORT: Bronchial Thermoplasty in Severe Asthma With Frequent Exacerbations
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Thermoplasty group Procedure: Bronchial thermoplasty with the Alair System and conventional therapy |
Device: Bronchial thermoplasty with the Alair System
|
| No Intervention: Control group Conventional therapy |
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
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
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Omalizumab therapy within the prior 4 months
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Allergic bronchopulmonary aspergillosis
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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
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Post-bronchodilator FEV1 of less than 30%
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Past diagnosis of COPD and chronic respiratory insufficiency
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Known coagulopathy or platelet dysfunction
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Use of anticoagulants
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Use of an internal or external pacemaker or internal cardiac defibrillator
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Contraindication to perform bronchoscopy
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Contraindication to perform general anesthesia
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpitaux Universitaires de Strasbourg | Strasbourg | France | 67091 |
Sponsors and Collaborators
- University Hospital, Strasbourg, France
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 5886