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

N/AUnknownNCT01974921

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau15 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Asthma

Interventions

ALAIR Catheter. Radiofrequency system.DEVICE

Radiofrequency with Alair Catheter trhough flexible bronchoscopy in three different sessions (right lower lobe, left lower lobe, both upper lobes).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.)

Locations (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

RECRUITING

Outcomes

Primary Outcomes

Bronchial smooth muscle.

Time frame: Change from baseline in bronchial smooth muscle at 6 months post-treatment..

Secondary Outcomes

Questionnaire of Quality of life (AQLQ)

Time frame: Change from baseline in AQLQ at 6 months post-treatment.

Questionnaire of asthma control (ACT)

Time frame: Change from baseline in ACT at 6 months post-treatment.

Number of exacerbations

Time frame: Change from baseline in number of exacerbations at 6 months post-treatment.

Number of hospitalizations

Time frame: Change from baseline in number of hospitalizations at 6 months post-treatment.

Respiratory function

Time frame: Change from baseline in respiratory function at 6 months post-treatment.

Radiological findings (thorax HRCT scan)

Time frame: Change from baseline in radiological findings at 6 months post-treatment.

Inflammatory markers

FeNO eNOSE Bronchial biopsies Sputum Serum

Time frame: Change from baseline in biological inflammatory markers at 6 months post-treatment.

Central Contacts

Alfons Torrego, M.D.

CONTACT

0034 936655972 atorrego@santpau.cat

Data from ClinicalTrials.gov

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