Bronchial Thermoplasty in Severe Asthma With Frequent Exacerbations (THERMASCORT)

University Hospital, Strasbourg, France

Status

Unknown

Conditions

Asthma

Treatments

Device: Bronchial thermoplasty with the Alair System

Study type

Interventional

Funder types

Other

Identifiers

NCT02464995

5886

Details and patient eligibility

About

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).

Enrollment

34 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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