Clinical trial · Interventional
Bicentric Prospective Study, Evaluating Bronchial THERMOPLASTY in a Patient Presenting Severe Uncontrolled Asthma
NCT01777360CI-TRIAL-00030236ASMATHERMunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Asthma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALAIR, radiofrequency catheter for bronchial THERMOPLASTY | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- THERMOPLASTY
- description
- ALAIR, radiofrequency catheter for bronchial THERMOPLASTY
- interventionNames
- Device: ALAIR, radiofrequency catheter for bronchial THERMOPLASTY
Primary outcomes (1)
- measure
- smooth muscle surface area
- timeFrame
- 3 month after THERMOPLASTY
- description
- Reduction in smooth muscle surface area, objectified on bronchial biopsies before and after THERMOPLASTY in patients presenting severe asthma.
Secondary outcomes (1)
- measure
- respiratory function
- timeFrame
- 12 month after thermoplasty
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDebray 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 28298402