Bronchial Thermoplasty in Severe Asthma With Frequent Exacerbations

University Hospital, Strasbourg, France1 site in 1 country34 target enrollmentJune 9, 2015

ConditionsAsthma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Asthma
Sponsor: University Hospital, Strasbourg, France
Enrollment: 34
Locations: 1
Primary Endpoint: Severe exacerbation rate (change from baseline)
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

June 9, 2015

End Date

November 9, 2022

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Strasbourg, France

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Severe exacerbation rate (change from baseline)

Time Frame: 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 Outcomes

Mean oral glucocorticosteroid dose (mg equivalent prednisone)(Baseline, 6 and 12 Months)
Pre- and post-bronchodilator FEV1(Baseline, 6 and 12 Months)
Asthma Quality of Life Questionnaire (AQLQ) Score(Baseline, 3, 6, 9 and 12 Months)
Time to the first severe asthma exacerbation(anytime)
Mild exacerbation rate(Baseline, 6 and 12 Months)
Asthma Control Questionnaire (ACQ) 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)