NCT02464995

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

June 9, 2015

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2022

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

5.4 years

First QC Date

June 3, 2015

Last Update Submit

May 29, 2019

Conditions

Asthma

Keywords

Asthma,Asthma exacerbationBronchial thermoplasty

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Thermoplasty group

EXPERIMENTAL

Procedure: Bronchial thermoplasty with the Alair System and conventional therapy

Device: Bronchial thermoplasty with the Alair System

Control group

NO INTERVENTION

Conventional therapy

Interventions

Bronchial thermoplasty with the Alair SystemDEVICE
Thermoplasty group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Bronchial Thermoplasty

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Catheter AblationRadiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 8, 2015

Study Start

June 9, 2015

Primary Completion

November 9, 2020

Study Completion

November 9, 2022

Last Updated

May 30, 2019

Record last verified: 2019-05

Locations

FR(1)