Bicentric Prospective Study, Evaluating Bronchial THERMOPLASTY in a Patient Presenting Severe Uncontrolled Asthma (ASMATHERM)
This study is currently recruiting participants.
Verified January 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Assistance Publique - Hôpitaux de Paris
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: January 23, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
- 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)
- increased bronchial smooth muscle surface area (>15% of the total surface area of the bronchial biopsy)
- 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).
Exclusion Criteria:
- Patient having had severe exacerbation of their asthma requiring strong doses of oral corticosteroids lasting at least one month.
- 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.
Contacts and Locations
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: | January 23, 2013 |
| 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 June 17, 2013