Bronchial Thermoplasty in Severe Asthma With Frequent Exacerbations (THERMASCORT)

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).

Study Overview

• Status: Unknown
• Conditions: Asthma
• Intervention / Treatment: Device: Bronchial thermoplasty with the Alair System

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Hôpitaux Universitaires de Strasbourg
    • Contact: Naji KHAYATH, PhD; Email: naji.khayath@chru-strasbourg.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thermoplasty group; Procedure: Bronchial thermoplasty with the Alair System and conventional therapy	Device: Bronchial thermoplasty with the Alair System
No Intervention: Control group; Conventional therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2015
• Primary Completion (Anticipated): November 9, 2020
• Study Completion (Anticipated): November 9, 2022

Study Registration Dates

• First Submitted: June 3, 2015
• First Submitted That Met QC Criteria: June 3, 2015
• First Posted (Estimate): June 8, 2015

Study Record Updates

• Last Update Posted (Actual): May 30, 2019
• Last Update Submitted That Met QC Criteria: May 29, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Asthma,; Asthma exacerbation; Bronchial thermoplasty
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 5886