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

Primary Purpose

Asthma

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
ALAIR Catheter. Radiofrequency system.
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Asthma focused on measuring Asthma, Bronchial Thermoplasty, Bronchial smooth muscle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.)

Sites / Locations

  • Hospital de la Santa Creu i Sant PauRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bronchial thermoplasty

Arm Description

ALAIR Catheter. Radiofrequency system.

Outcomes

Primary Outcome Measures

Bronchial smooth muscle.

Secondary Outcome Measures

Questionnaire of Quality of life (AQLQ)
Questionnaire of asthma control (ACT)
Number of exacerbations
Number of hospitalizations
Respiratory function
Radiological findings (thorax HRCT scan)
Inflammatory markers
FeNO eNOSE Bronchial biopsies Sputum Serum

Full Information

First Posted
October 22, 2013
Last Updated
November 19, 2015
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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1. Study Identification

Unique Protocol Identification Number
NCT01974921
Brief Title
Study of Physiopathological Mechanisms and Results of Treatment With Bronchial Thermoplasty in Severe Asthma
Official Title
Study of Physiopathological Mechanisms and Results of Treatment With Bronchial Thermoplasty in Severe Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Bronchial Thermoplasty, Bronchial smooth muscle

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bronchial thermoplasty
Arm Type
Experimental
Arm Description
ALAIR Catheter. Radiofrequency system.
Intervention Type
Device
Intervention Name(s)
ALAIR Catheter. Radiofrequency system.
Intervention Description
Radiofrequency with Alair Catheter trhough flexible bronchoscopy in three different sessions (right lower lobe, left lower lobe, both upper lobes).
Primary Outcome Measure Information:
Title
Bronchial smooth muscle.
Time Frame
Change from baseline in bronchial smooth muscle at 6 months post-treatment..
Secondary Outcome Measure Information:
Title
Questionnaire of Quality of life (AQLQ)
Time Frame
Change from baseline in AQLQ at 6 months post-treatment.
Title
Questionnaire of asthma control (ACT)
Time Frame
Change from baseline in ACT at 6 months post-treatment.
Title
Number of exacerbations
Time Frame
Change from baseline in number of exacerbations at 6 months post-treatment.
Title
Number of hospitalizations
Time Frame
Change from baseline in number of hospitalizations at 6 months post-treatment.
Title
Respiratory function
Time Frame
Change from baseline in respiratory function at 6 months post-treatment.
Title
Radiological findings (thorax HRCT scan)
Time Frame
Change from baseline in radiological findings at 6 months post-treatment.
Title
Inflammatory markers
Description
FeNO eNOSE Bronchial biopsies Sputum Serum
Time Frame
Change from baseline in biological inflammatory markers at 6 months post-treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alfons Torrego, M.D.
Phone
0034 936655972
Ext
5967
Email
atorrego@santpau.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfons Torrego, M.D.
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfons Torrego, M.D.
First Name & Middle Initial & Last Name & Degree
Ana Muñoz, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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