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Bronchial Thermoplasty in Severe Asthma With Frequent Exacerbations (THERMASCORT)

Primary Purpose

Asthma

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Bronchial thermoplasty with the Alair System
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma,, Asthma exacerbation, Bronchial thermoplasty

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpitaux Universitaires de StrasbourgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Thermoplasty group

Control group

Arm Description

Procedure: Bronchial thermoplasty with the Alair System and conventional therapy

Conventional therapy

Outcomes

Primary Outcome Measures

Severe exacerbation rate (change from baseline)
A severe exacerbation is defined by a burst of systemic corticosteroids >3 days

Secondary Outcome Measures

Time to the first severe asthma exacerbation
Mean oral glucocorticosteroid dose (mg equivalent prednisone)
Mild exacerbation rate
Pre- and post-bronchodilator FEV1
Asthma Control Questionnaire (ACQ) Score
Asthma Quality of Life Questionnaire (AQLQ) Score
Structural airway remodeling using CT
Inflammatory cells and markers in induced sputum

Full Information

First Posted
June 3, 2015
Last Updated
May 29, 2019
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT02464995
Brief Title
Bronchial Thermoplasty in Severe Asthma With Frequent Exacerbations
Acronym
THERMASCORT
Official Title
Bronchial Thermoplasty in Severe Asthma With Frequent Exacerbations
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 9, 2015 (Actual)
Primary Completion Date
November 9, 2020 (Anticipated)
Study Completion Date
November 9, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma,, Asthma exacerbation, Bronchial thermoplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thermoplasty group
Arm Type
Experimental
Arm Description
Procedure: Bronchial thermoplasty with the Alair System and conventional therapy
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Conventional therapy
Intervention Type
Device
Intervention Name(s)
Bronchial thermoplasty with the Alair System
Primary Outcome Measure Information:
Title
Severe exacerbation rate (change from baseline)
Description
A severe exacerbation is defined by a burst of systemic corticosteroids >3 days
Time Frame
Baseline, 6 months and 12 months after the last thermoplasty procedure
Secondary Outcome Measure Information:
Title
Time to the first severe asthma exacerbation
Time Frame
anytime
Title
Mean oral glucocorticosteroid dose (mg equivalent prednisone)
Time Frame
Baseline, 6 and 12 Months
Title
Mild exacerbation rate
Time Frame
Baseline, 6 and 12 Months
Title
Pre- and post-bronchodilator FEV1
Time Frame
Baseline, 6 and 12 Months
Title
Asthma Control Questionnaire (ACQ) Score
Time Frame
Baseline, 3, 6, 9 and 12 Months
Title
Asthma Quality of Life Questionnaire (AQLQ) Score
Time Frame
Baseline, 3, 6, 9 and 12 Months
Title
Structural airway remodeling using CT
Time Frame
Baseline and 12 Months
Title
Inflammatory cells and markers in induced sputum
Time Frame
Time Frame: Baseline and 12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naji KHAYATH, PhD
Email
naji.khayath@chru-strasbourg.fr

12. IPD Sharing Statement

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Bronchial Thermoplasty in Severe Asthma With Frequent Exacerbations

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