NCT01777360

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at below P25 for phase_3 asthma

Timeline
Completed

Started Dec 2012

Longer than P75 for phase_3 asthma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

November 7, 2017

Status Verified

November 1, 2017

Enrollment Period

4.5 years

First QC Date

January 17, 2013

Last Update Submit

November 6, 2017

Conditions

Asthma

Keywords

severeuncontrolled

Outcome Measures

Primary Outcomes (1)

  • smooth muscle surface area

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

    3 month after THERMOPLASTY

Secondary Outcomes (1)

  • respiratory function

    12 month after thermoplasty

Study Arms (1)

THERMOPLASTY

EXPERIMENTAL

ALAIR, radiofrequency catheter for bronchial THERMOPLASTY

Device: ALAIR, radiofrequency catheter for bronchial THERMOPLASTY

Interventions

ALAIR, radiofrequency catheter for bronchial THERMOPLASTYDEVICE

radiofrequency catheter for bronchial THERMOPLASTY

THERMOPLASTY

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bichat Hospital

Paris, 75018, France

Location

Related Publications (1)

  • 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.

    PMID: 28298402DERIVED

MeSH Terms

Conditions

AsthmaLymphoma, Follicular

Interventions

Bronchial Thermoplasty

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative Disorders

Intervention Hierarchy (Ancestors)

Catheter AblationRadiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Aubier Michel

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2013

First Posted

January 28, 2013

Study Start

December 1, 2012

Primary Completion

June 1, 2017

Study Completion

September 1, 2018

Last Updated

November 7, 2017

Record last verified: 2017-11

Locations

FR(1)