Bronchial Thermoplasty in Severe Asthma With Frequent Exacerbations

NCT ID: NCT02464995

Last Updated: 2019-05-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-09
• Study Completion Date: 2022-11-09

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).

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Thermoplasty group

Procedure: Bronchial thermoplasty with the Alair System and conventional therapy

Group Type: EXPERIMENTAL

Bronchial thermoplasty with the Alair System

Intervention Type: DEVICE

Control group

Conventional therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bronchial thermoplasty with the Alair System

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Naji KHAYATH, PhD

Role: primary

naji.khayath@chru-strasbourg.fr

Other Identifiers

5886

Identifier Type: -

Identifier Source: org_study_id