Bronchial Thermoplasty for Severe Asthma With Dynamic Hyperinflation (HEAT-SA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02618551|
Recruitment Status : Recruiting
First Posted : December 1, 2015
Last Update Posted : March 20, 2018
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).
|Condition or disease||Intervention/treatment||Phase|
|Asthma Hyperinflation||Procedure: Bronchial thermoplasty for treatment of severe asthma||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Evaluation of the Efficiency of Bronchial Thermoplasty on Dynamic Hyperinflation in Uncontrolled Severe Asthma|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Patients will be treated by three bronchial thermoplasty sessions.
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.
- Evolution of dynamic hyperinflation [ Time Frame: 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.
- Structural modification of the bronchial wall [ Time Frame: 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 [ Time Frame: 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.
- Assess side effects [ Time Frame: 3 months ]Listing of thermoplasty complications (bronchitis, bronchospasm, exacerbation of asthma, hemoptysis, bronchiectasis) by medical staff
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02618551
|Contact: Alain DIDIER, MD||0567771850 ext +email@example.com|
|Contact: Nicolas GUIBERT, MD||0567771836 ext +firstname.lastname@example.org|
|Toulouse, Midi Pyrenees, France, 31059|
|Contact: Alain DIDIER, MD 0567771850 ext +33 email@example.com|
|Contact: Nicolas GUIBERT, MD 0567771836 ext +33 firstname.lastname@example.org|
|Principal Investigator: Alain DIDIER, MD|
|Sub-Investigator: Nicolas GUIBERT, MD|
|Sub-Investigator: Christophe HERMANT, MD|
|Principal Investigator:||Alain DIDIER, MD||Toulouse Rangueil Larrey University Hospital|