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

Not Applicable

• Conditions: Asthma
• Interventions: Device: ALAIR Catheter. Radiofrequency system.

• Registration Number: NCT01974921
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-11-01
• Study First Posted: 2013-11-03
• Status Verified: 2015-10
• Last Update Submitted: 2015-11-19
• Last Update Posted: 2015-11-20
• Primary Completion: 2016-06
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bronchial thermoplasty	ALAIR Catheter. Radiofrequency system.	ALAIR Catheter. Radiofrequency system.

Primary Outcome Measures

Name	Time	Method
Bronchial smooth muscle.	Change from baseline in bronchial smooth muscle at 6 months post-treatment..

Secondary Outcome Measures

Name	Time	Method
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.
Questionnaire of Quality of life (AQLQ)	Change from baseline in AQLQ at 6 months post-treatment.
Number of exacerbations	Change from baseline in number of exacerbations at 6 months post-treatment.
Radiological findings (thorax HRCT scan)	Change from baseline in radiological findings at 6 months post-treatment.
Questionnaire of asthma control (ACT)	Change from baseline in ACT at 6 months post-treatment.
Inflammatory markers	Change from baseline in biological inflammatory markers at 6 months post-treatment.	FeNO eNOSE Bronchial biopsies Sputum Serum

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain