Bronchial Thermoplasty in Severe Asthma With Frequent Exacerbations

Asthma Clinical Trial

— THERMASCORT  

Official title:

Bronchial Thermoplasty in Severe Asthma With Frequent Exacerbations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02464995
• Other study ID #: 5886
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2015
• Est. completion date: November 9, 2022

Study information

• Verified date: May 2019
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: November 9, 2022
• Est. primary completion date: November 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Bronchial thermoplasty with the Alair System

Locations

Country	Name	City	State
France	Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe exacerbation rate (change from baseline)	A severe exacerbation is defined by a burst of systemic corticosteroids >3 days	Baseline, 6 months and 12 months after the last thermoplasty procedure
Secondary	Time to the first severe asthma exacerbation		anytime
Secondary	Mean oral glucocorticosteroid dose (mg equivalent prednisone)		Baseline, 6 and 12 Months
Secondary	Mild exacerbation rate		Baseline, 6 and 12 Months
Secondary	Pre- and post-bronchodilator FEV1		Baseline, 6 and 12 Months
Secondary	Asthma Control Questionnaire (ACQ) Score		Baseline, 3, 6, 9 and 12 Months
Secondary	Asthma Quality of Life Questionnaire (AQLQ) Score		Baseline, 3, 6, 9 and 12 Months
Secondary	Structural airway remodeling using CT		Baseline and 12 Months
Secondary	Inflammatory cells and markers in induced sputum		Time Frame: Baseline and 12 Months