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