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

NCT ID: NCT01974921

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-09-30

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.

Conditions

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Asthma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Bronchial thermoplasty

ALAIR Catheter. Radiofrequency system.

Group Type EXPERIMENTAL

ALAIR Catheter. Radiofrequency system.

Intervention Type DEVICE

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

Interventions

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ALAIR Catheter. Radiofrequency system.

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

Intervention Type DEVICE

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.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alfons Torrego, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Alfons Torrego, M.D.

Role: CONTACT

[email protected]
0034 936655972 ext. 5967

Other Identifiers

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IIBSP-TER-2013-70

Identifier Type: -

Identifier Source: org_study_id