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NCT Number: NCT02618551

Bronchial Thermoplasty for Severe Asthma With Dynamic Hyperinflation

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DIDIER Alain

Toulouse, Midi Pyrenees, 31059, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bronchial thermoplasty for treatment of severe asthma

Procedure

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: HEAT-SA

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Dec 1, 2015
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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