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

NCT01974921 | Unknown DMC

• 1 other identifier: IIBSP-TER-2013-70
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Keywords

Asthma; Bronchial Thermoplasty; Bronchial smooth muscle

Outcome Measures

Primary Outcomes (1)

• Bronchial smooth muscle.

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

Secondary Outcomes (7)

• 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.

Study Arms (1)

Bronchial thermoplasty

EXPERIMENTAL

ALAIR Catheter. Radiofrequency system.

Device: ALAIR Catheter. Radiofrequency system.

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).

Bronchial thermoplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

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

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Alfons Torrego, M.D.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alfons Torrego, M.D.

CONTACT

0034 936655972; atorrego@santpau.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: November 4, 2013
• Study Start: September 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 20, 2015

Record last verified: 2015-10

Locations

ES (1)