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Bronchial Thermoplasty for Severe Asthma With Dynamic Hyperinflation (HEAT-SA)

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ClinicalTrials.gov Identifier: NCT02618551
Recruitment Status : Recruiting
First Posted : December 1, 2015
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment Phase
Asthma Hyperinflation Procedure: Bronchial thermoplasty for treatment of severe asthma Not Applicable

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Intervention
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.





Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Assess side effects [ Time Frame: 3 months ]
    Listing of thermoplasty complications (bronchitis, bronchospasm, exacerbation of asthma, hemoptysis, bronchiectasis) by medical staff



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Alain DIDIER, MD 0567771850 ext +33 didier.a@chu-toulouse.fr
Contact: Nicolas GUIBERT, MD 0567771836 ext +33 guibert.n@chu-toulouse.fr

Locations
France
DIDIER Alain Recruiting
Toulouse, Midi Pyrenees, France, 31059
Contact: Alain DIDIER, MD    0567771850 ext +33    didier.a@chu-toulouse.fr   
Contact: Nicolas GUIBERT, MD    0567771836 ext +33    guibert.n@chu-toulouse.fr   
Principal Investigator: Alain DIDIER, MD         
Sub-Investigator: Nicolas GUIBERT, MD         
Sub-Investigator: Christophe HERMANT, MD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Alain DIDIER, MD Toulouse Rangueil Larrey University Hospital

Publications:

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02618551     History of Changes
Other Study ID Numbers: RC31/14/7422
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

Keywords provided by University Hospital, Toulouse:
Thermoplasty
Severe asthma
Dynamic hyperinflation

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases