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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thermoplasty group | Experimental | Procedure: Bronchial thermoplasty with the Alair System and conventional therapy |
|
| Control group | No Intervention | Conventional therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bronchial thermoplasty with the Alair System | Device |
|
| 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 |
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaires de Strasbourg | Recruiting | Strasbourg | 67091 | France |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000074060 | Bronchial Thermoplasty |
| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
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| 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 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D055011 |
| Ablation Techniques |
| D013514 | Surgical Procedures, Operative |