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

November 19, 2015 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
The purpose of this study is to evaluate clinical and histological response to bronchial thermoplasty in severe asthma patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Principal Investigator:
          • Alfons Torrego, M.D.
        • Sub-Investigator:
          • Ana Muñoz, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bronchial thermoplasty
ALAIR Catheter. Radiofrequency system.
Device: ALAIR Catheter. Radiofrequency system.
Radiofrequency with Alair Catheter trhough flexible bronchoscopy in three different sessions (right lower lobe, left lower lobe, both upper lobes).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bronchial smooth muscle.
Time Frame: Change from baseline in bronchial smooth muscle at 6 months post-treatment..
Change from baseline in bronchial smooth muscle at 6 months post-treatment..

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire of Quality of life (AQLQ)
Time Frame: Change from baseline in AQLQ at 6 months post-treatment.
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.
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.
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.
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.
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.
Change from baseline in radiological findings at 6 months post-treatment.
Inflammatory markers
Time Frame: Change from baseline in biological inflammatory markers at 6 months post-treatment.
FeNO eNOSE Bronchial biopsies Sputum Serum
Change from baseline in biological inflammatory markers at 6 months post-treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Alfons Torrego, M.D., Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

October 22, 2013

First Submitted That Met QC Criteria

November 1, 2013

First Posted (Estimate)

November 3, 2013

Study Record Updates

Last Update Posted (Estimate)

November 20, 2015

Last Update Submitted That Met QC Criteria

November 19, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-TER-2013-70

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

Clinical Trials on ALAIR Catheter. Radiofrequency system.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe