Bronchial Thermoplasty for Severe Asthma With Dynamic Hyperinflation

Not Applicable

Completed

• Conditions: Hyperinflation; Asthma
• Interventions: Procedure: Bronchial thermoplasty for treatment of severe asthma

• Registration Number: NCT02618551
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

Bronchial thermoplasty is a treatment for severe asthma that consist in decreasing the thickness of bronchial muscle by heat using a catheter inserted into the bronchi under direct vision with the help of an endoscope This treatment has shown efficacy on symptoms, quality of life and the number of exacerbations related to severe asthma.

This clinical study evaluates the efficiency of this treatment on the dynamic hyperinflation phenomenon (worsening of bronchial obstruction during exercise in patients with asthma contributing to worsening shortness of breath).

Detailed Description

Bronchial thermoplasty is a recently validated bronchoscopic technique for the management of severe asthma that treats smooth muscle by radiofrequency to reduce its thickness. This procedure leads to improved asthma control and quality of life, but also to decreased exacerbations frequency and number of emergencies hospitalizations. This treatment requires 3 procedures every 3 to 4 weeks.

The pathophysiological mechanisms underlying its effectiveness need to be better understood for an improved selection of best candidates. In particular, there is a discrepancy between the improvement observed in symptoms (ACQ), quality of life (AQLQ) and the lack of improvement in forced expiratory volume in 1 second (FEV1). Investigator assume that this paradox is due to an efficiency appearing at effort, targeting dynamic hyperinflation phenomenon.

The objective of this study is to evaluate the influence of bronchial thermoplasty on dynamic hyperinflation in severe asthma. The secondary objectives are to assess the effectiveness of bronchial thermoplasty (ACQ, AQLQ) in a selected population of patients with dynamic hyperinflation and to describe bronchial wall structural changes by probe-based confocal LASER endomicroscopy (pCLE).

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-26
• Study First Submitted QC: 2015-11-26
• Study First Posted: 2015-12-01
• Primary Completion: 2021-05-06
• Study Completion: 2021-05-06
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-15
• Last Update Posted: 2022-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Severe asthma, uncontrolled despite optimal treatment according to GINA (global initiative for asthma) recommendations
• At least 2 exacerbations treated by systemic steroids in the last year
• FEV1 between 40 and 80% of predicted values and dynamic hyperinflation (defined as a decrease in inspiratory capacity by more than 500 ml during exercise)

Exclusion Criteria

• Current asthma exacerbation or respiratory infection
• History of exacerbation after bronchoscopy
• FEV1 < 40% of predicted values
• Oxygen saturation < 90%
• Contra-indications to ALAIR catheter system : pacemaker or other electronic implanted device
• Allergy to Remifentanyl or Propofol
• pregnancy; breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Bronchial thermoplasty for treatment of severe asthma	Patients will be treated by three bronchial thermoplasty sessions.

Primary Outcome Measures

Name	Time	Method
Evolution of dynamic hyperinflation	3 months	A lung plethysmography will be used to patients to see evolution of dynamic hyperinflation after bronchial thermoplasty, defined as a decrease in inspiratory capacity by more than 500 ml during exercise.; The plethysmography will be made before the first procedure and three months after the third procedure.

Secondary Outcome Measures

Name	Time	Method
Assess side effects	3 months	Listing of thermoplasty complications (bronchitis, bronchospasm, exacerbation of asthma, hemoptysis, bronchiectasis) by medical staff
Structural modification of the bronchial wall	3 months	Description of structural modification of the bronchial wall by probe-based confocal LASER endomicroscopy (pCLE) induced by bronchial thermoplasty
Efficiency of bronchial thermoplasty on asthma	3 months	Efficiency of bronchial thermoplasty on asthma control (ACQ) and quality of life (AQLQ) in a selected population of patients with severe asthma with dynamic hyperinflation.

Trial Locations

Locations (1)

DIDIER Alain; 🇫🇷 Toulouse, Midi Pyrenees, France