Bronchial Thermoplasty in Severe Asthma With Frequent Exacerbations

Bronchial Thermoplasty in Severe Asthma With Frequent Exacerbations

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).

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