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

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

Status: Unknown

Conditions: Asthma

Treatments: Device: ALAIR Catheter. Radiofrequency system.

Study type: Interventional

Funder types: Other

Identifiers

NCT01974921

IIBSP-TER-2013-70

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Bronchial thermoplasty

Experimental group

Description:

ALAIR Catheter. Radiofrequency system.

Treatment:

Device: ALAIR Catheter. Radiofrequency system.