Status:
COMPLETED
Airway Remodeling During Mepolizumab Treatment
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
GlaxoSmithKline
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Brief Summary
Chronic airway changes, such as smooth muscle hypertrophy/hyperplasia, reticular basement membrane (RBM) thickening, goblet cells hyperplasia characterize severe asthma. Chronic inflammation, and espe...
Detailed Description
1. Scientific Rationale \& Hypothesis: Chronic airway changes, such as smooth muscle hypertrophy/hyperplasia, reticular basement membrane thickening, goblet cells hyperplasia characterize severe a...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- adult \>18 years,
- severe uncontrolled asthma, defined as eosinophil blood count \>300/mm3 in the previous 12 months and at least 2 exacerbations in the previous 12 months or requiring oral steroids for more than half of the previous year,
- indication for mepolizumab decided by an asthma specialist,
- efficient contraception, for women of reproductive age
- Exclusion criteria :
- pregnancy,
- smokers or ex smokers \>10 pack/yr,
- contra indication for fiberoptic bronchoscopy (allergy to xylocain, antiaggregant or anticoagulant treatment...),
- contra indication for mepolizumab,
- patient who previously received mepolizumab or already received mepolizumab at inclusion,
- participation in another interventional trial
Exclusion
Key Trial Info
Start Date :
April 24 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 21 2022
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03797404
Start Date
April 24 2019
End Date
June 21 2022
Last Update
January 20 2023
Active Locations (1)
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1
Bichat hospital
Paris, France, 75018