Clinical trial NCT02464995: Bronchial Thermoplasty in Severe Asthma With Frequent Exacerbations
Official title: Bronchial Thermoplasty in Severe Asthma With Frequent Exacerbations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: Asthma,
Asthma exacerbation
Bronchial thermoplasty
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Severe exacerbation rate (change from baseline)
timeFrame: Baseline, 6 months and 12 months after the last thermoplasty procedure
Secondary outcomes:
measure: Time to the first severe asthma exacerbation
timeFrame: anytime
measure: Mean oral glucocorticosteroid dose (mg equivalent prednisone)
timeFrame: Baseline, 6 and 12 Months
measure: Mild exacerbation rate
timeFrame: Baseline, 6 and 12 Months
measure: Pre- and post-bronchodilator FEV1
timeFrame: Baseline, 6 and 12 Months
measure: Asthma Control Questionnaire (ACQ) Score
timeFrame: Baseline, 3, 6, 9 and 12 Months
measure: Asthma Quality of Life Questionnaire (AQLQ) Score
timeFrame: Baseline, 3, 6, 9 and 12 Months
measure: Structural airway remodeling using CT
timeFrame: Baseline and 12 Months
measure: Inflammatory cells and markers in induced sputum
timeFrame: Time Frame: Baseline and 12 Months
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
References: