Bicentric Prospective Study, Evaluating Bronchial THERMOPLASTY in a Patient Presenting Severe Uncontrolled Asthma (ASMATHERM)
|Asthma||Device: ALAIR, radiofrequency catheter for bronchial THERMOPLASTY||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Bicentric Prospective Study, Evaluating Bronchial THERMOPLASTY in a Patient Presenting Severe Uncontrolled Asthma|
- smooth muscle surface area [ Time Frame: 3 month after THERMOPLASTY ]Reduction in smooth muscle surface area, objectified on bronchial biopsies before and after THERMOPLASTY in patients presenting severe asthma.
- respiratory function [ Time Frame: 12 month after thermoplasty ]number of severe exacerbations
|Actual Study Start Date:||December 2012|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
ALAIR, radiofrequency catheter for bronchial THERMOPLASTY
Device: ALAIR, radiofrequency catheter for bronchial THERMOPLASTY
radiofrequency catheter for bronchial THERMOPLASTY
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777360
|Paris, France, 75018|
|Principal Investigator:||Aubier Michel||Assistance Publique - Hôpitaux de Paris|