NCT02618551

Bronchial Thermoplasty for Severe Asthma With Dynamic Hyperinflation

Evaluation of the Efficiency of Bronchial Thermoplasty on Dynamic Hyperinflation in Uncontrolled Severe Asthma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Asthma
• Hyperinflation

Interventions

Type	Name	Description
PROCEDURE	Bronchial thermoplasty for treatment of severe asthma	Three sessions of bronchial thermoplasty are needed to treat patients. There will be 3 to 4 weeks between each procedure. Bronchial thermoplasty procedure is performed under general anesthesia. The medical device used in this research to achieve the thermoplasty is the Alair system (class IIb medical device ; Boston scientific) A confocal endomicroscopy will be conducted at the first and final session of thermoplasty. This examination involves analyzing and recording the structure of bronchi microscopy through a small catheter placed on the bronchus. Photographs of the bronchi will be realized.

Timeline

• Start date: 2015-11-01
• Primary completion: 2021-05-06
• Completion: 2021-05-06
• First posted: 2015-12-01
• Last updated: 2022-01-05

Locations

1 site across 1 country: France