Bicentric Prospective Study, Evaluating Bronchial THERMOPLASTY in a Patient Presenting Severe Uncontrolled Asthma (ASMATHERM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01777360
First received: January 17, 2013
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

To determine, from patients presenting severe asthma and an increase in bronchial smooth muscle mass, those who would be the best candidates for bronchial THERMOPLASTY. THERMOPLASTY should improve control of the asthma, reduce day-to-day symptoms and severe exacerbations, and improve respiratory function


Condition Intervention Phase
Asthma
Device: ALAIR, radiofrequency catheter for bronchial THERMOPLASTY
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bicentric Prospective Study, Evaluating Bronchial THERMOPLASTY in a Patient Presenting Severe Uncontrolled Asthma

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • smooth muscle surface area [ Time Frame: 3 month after THERMOPLASTY ] [ Designated as safety issue: No ]
    Reduction in smooth muscle surface area, objectified on bronchial biopsies before and after THERMOPLASTY in patients presenting severe asthma.


Secondary Outcome Measures:
  • respiratory function [ Time Frame: 12 month after thermoplasty ] [ Designated as safety issue: No ]
    number of severe exacerbations


Estimated Enrollment: 80
Study Start Date: December 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: THERMOPLASTY
ALAIR, radiofrequency catheter for bronchial THERMOPLASTY
Device: ALAIR, radiofrequency catheter for bronchial THERMOPLASTY
radiofrequency catheter for bronchial THERMOPLASTY

Detailed Description:

Bicentric prospective study, evaluating bronchial THERMOPLASTY in patients with severe uncontrolled asthma and significant bronchial smooth muscle mass. Primary Objective is to determine patients who would be the best candidates for bronchial THERMOPLASTY which should improve control of the asthma, reduce day-to-day symptoms and severe exacerbations, and improve respiratory function. Primary Endpoint will be the reduction in smooth muscle surface area, objectified on bronchial biopsies before and after THERMOPLASTY in patients presenting severe asthma and secondary criteria are:

  • number of severe exacerbations (with oral corticosteroids, emergency room visits, hospitalizations)
  • time until the first exacerbation
  • respiratory function
  • control of the asthma (ACQ - Asthma Control Questionnaire)
  • quality of life (AQLQ - Asthma Quality of Life Questionnaire)
  • fraction of exhaled nitric oxide (FENO)
  • measurement of the thickness of the bronchial wall using tomodensitometry (scan). The inclusion of period of 28 months is limited to a maximum of 80 subjects. The actual number will be determined using the two-stage stop method. An intermediate analysis will be carried out following the evaluation and statistical analysis of the 40 patients.
  • If the primary endpoint p-value is <0.0294, success will be declared and the inclusions will cease.
  • If the p-value is >0.0294, additional patients will be recruited up to a total of 80 patients included and assessed. At inclusion, sociodemographic data will be collected, number of exacerbations per year, date of fibroscopy, data on asthma control (ACQ), data on quality of life (AQLQ), respiratory function (EFR), fraction of exhaled nitric oxide (FENO), thickness of the bronchial wall evaluated using scanner and surface area of smooth muscle in the bronchial sub-mucous layer will be evaluated. At 3 months post-THERMOPLASTY, same data will be collected. One year after THERMOPLASTY, number of exacerbations, data on asthma control (ACQ),and quality of life (AQLQ), respiratory function (EFR), fraction of exhaled nitric oxide (FENO), thickness of the bronchial wall and possible complications will be collected.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18-75 years
  • Patients with severe asthma that is uncontrolled despite optimal treatment and who have presented at least one exacerbation while taking oral corticosteroids within the previous 12 months
  • With a variable bronchial obstruction (FEV1 >30 and <70% of theoretical)
  • Patients known to have severe asthma under the care of the Pneumology Department of BICHAT Hospital in Paris (Prof. AUBIER) and the Nord Hospital in Marseilles (Prof. CHANEZ).
  • Covered by French national health insurance.

Exclusion Criteria:

  • Patient having had severe exacerbation of their asthma requiring high doses of oral corticosteroids (> 60 mg) during the month before inclusion.
  • Patient with exacerbation.
  • Patient having presented a severe exacerbation or other undesirable reactions related to a bronchoscopy.
  • Patient having an FEV1 <30% of theoretical after taking a short-acting B2 mimetic. - Patient having oxygen saturation measured by pulse oximetry <90% in ambient air.
  • Patient presenting clinically significant electrocardiogram abnormalities.
  • Patient presenting an uncontrolled co-morbidity.
  • Patient presenting coagulation and platelet abnormalities.
  • Patient having a habitual contraindication to a bronchial endoscopy.
  • Patient having hemostasis disorders
  • Presence of a pacemaker, internal defibrillator, or other implantable electronic device.
  • Contraindication to corticosteroids at high doses and atarax
  • Pregnant women and lactating
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777360

Contacts
Contact: KEDZIA Cécile 01 44 84 17 33 cecile.kedzia@sls.aphp.fr
Contact: AMERALI Fadela 01 44 84 17 17 fadila.amerali@sls.aphp.fr

Locations
France
Bichat Hospital Recruiting
Paris, France, 75018
Contact: Aubier Michel    01 40 25 68 80    michel.aubier@bch.aphp.fr   
Principal Investigator: Aubier Michel         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Boston Scientific Corporation
Investigators
Principal Investigator: Aubier Michel Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01777360     History of Changes
Other Study ID Numbers: P 120102
Study First Received: January 17, 2013
Last Updated: August 25, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
severe
uncontrolled

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 22, 2014