Study of Physiopathological Mechanisms and Results of Treatment With Bronchial Thermoplasty in Severe Asthma

Study Overview
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Brief Summary
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The purpose of this study is to evaluate clinical and histological response to bronchial thermoplasty in severe asthma patients.

Detailed Description
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Bronchial thermoplasty is a new therapeutic tool for severe and uncontrolled asthma patients. Clinical trials have demonstrated clinical benefits regarding quality of life and exacerbations. Animal models suggested the reduction of bronchial smooth muscle as the principal responsible for the clinical benefits observed in asthma patients treated in the clinical trials, although there is little information about its mechanism of action, and limited to a very small number of case reports. Given that the mechanism of action of bronchial thermoplasty is still not well understood, we proposed a biological study in asthma patients treated with bronchial thermoplasty with the purpose to analyze changes in inflammatory markers and histological samples, as well as its correlation with clinical outcomes in real practice.

Official Title
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Study of Physiopathological Mechanisms and Results of Treatment With Bronchial Thermoplasty in Severe Asthma

Conditions
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Asthma

Intervention / Treatment
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* Device: ALAIR Catheter. Radiofrequency system.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients under 18 years old. Severe persistent asthma according to GINA. Inhaled corticosteroids and long-acting ß2 agonist (LABA). Other medications for asthma, as oral corticosteroids, anti-IgE, theofiline, etc. are also acceptable. Asthma Quality of Life Questionnaire (AQLQ) < 7 Asthma Control Test (ACT) < 19 ≥ 2 exacerbations in last year Exclusion Criteria: History of cigarette smoking with > 15 pack/years. Other respiratory diseases. Comorbidity that can justify the symptoms of the patients. Life-threating unstable asthma. Any contraindication to perform a bronchoscopy (respiratory insufficiency, coagulation abnormalities, allergy to sedative drugs, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bronchial thermoplasty<br>ALAIR Catheter. Radiofrequency system. | Device: ALAIR Catheter. Radiofrequency system.<br>* Radiofrequency with Alair Catheter trhough flexible bronchoscopy in three different sessions (right lower lobe, left lower lobe, both upper lobes).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchial smooth muscle. |  | Change from baseline in bronchial smooth muscle at 6 months post-treatment.. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire of Quality of life (AQLQ) |  | Change from baseline in AQLQ at 6 months post-treatment. | 
| Questionnaire of asthma control (ACT) |  | Change from baseline in ACT at 6 months post-treatment. | 
| Number of exacerbations |  | Change from baseline in number of exacerbations at 6 months post-treatment. | 
| Number of hospitalizations |  | Change from baseline in number of hospitalizations at 6 months post-treatment. | 
| Respiratory function |  | Change from baseline in respiratory function at 6 months post-treatment. | 
| Radiological findings (thorax HRCT scan) |  | Change from baseline in radiological findings at 6 months post-treatment. | 
| Inflammatory markers | FeNO eNOSE Bronchial biopsies Sputum Serum | Change from baseline in biological inflammatory markers at 6 months post-treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Bronchial Thermoplasty, Bronchial smooth muscle