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

Primary Purpose

Asthma

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
ALAIR, radiofrequency catheter for bronchial THERMOPLASTY
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring severe, uncontrolled

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bichat Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

THERMOPLASTY

Arm Description

ALAIR, radiofrequency catheter for bronchial THERMOPLASTY

Outcomes

Primary Outcome Measures

smooth muscle surface area
Reduction in smooth muscle surface area, objectified on bronchial biopsies before and after THERMOPLASTY in patients presenting severe asthma.

Secondary Outcome Measures

respiratory function
number of severe exacerbations

Full Information

First Posted
January 17, 2013
Last Updated
November 6, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01777360
Brief Title
Bicentric Prospective Study, Evaluating Bronchial THERMOPLASTY in a Patient Presenting Severe Uncontrolled Asthma
Acronym
ASMATHERM
Official Title
Bicentric Prospective Study, Evaluating Bronchial THERMOPLASTY in a Patient Presenting Severe Uncontrolled Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
severe, uncontrolled

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
THERMOPLASTY
Arm Type
Experimental
Arm Description
ALAIR, radiofrequency catheter for bronchial THERMOPLASTY
Intervention Type
Device
Intervention Name(s)
ALAIR, radiofrequency catheter for bronchial THERMOPLASTY
Intervention Description
radiofrequency catheter for bronchial THERMOPLASTY
Primary Outcome Measure Information:
Title
smooth muscle surface area
Description
Reduction in smooth muscle surface area, objectified on bronchial biopsies before and after THERMOPLASTY in patients presenting severe asthma.
Time Frame
3 month after THERMOPLASTY
Secondary Outcome Measure Information:
Title
respiratory function
Description
number of severe exacerbations
Time Frame
12 month after thermoplasty

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aubier Michel
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bichat Hospital
City
Paris
ZIP/Postal Code
75018
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28298402
Citation
Debray MP, Dombret MC, Pretolani M, Thabut G, Alavoine L, Brillet PY, Taille C, Khalil A, Chanez P, Aubier M. Early computed tomography modifications following bronchial thermoplasty in patients with severe asthma. Eur Respir J. 2017 Mar 15;49(3):1601565. doi: 10.1183/13993003.01565-2016. Print 2017 Mar.
Results Reference
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Bicentric Prospective Study, Evaluating Bronchial THERMOPLASTY in a Patient Presenting Severe Uncontrolled Asthma

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