Status:
COMPLETED
Effect of Mepolizumab on Decrease of Systemic Corticosteroids in Patients With Severe Eosinophilic Asthma
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Asthma; Eosinophilic
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of the study is to measure the effect of mepolizumab on declines in oral corticosteroid therapy (prednisolone or prednisone) in patients with severe eosinophilic asthma. Asthma ...
Eligibility Criteria
Inclusion
- Severe eosinophilic asthma
- Patient on inhaled therapy with inhaled corticosteroid and long-acting bronchodilator for at least 6 months
- Patient under oral corticosteroid therapy (prednisolone or prednisone) for at least 6 months and unmodified in the last 4 weeks before the first injection
- Patient able to provide informed and written consent
- Obtaining the temporary authorization for nominative use for mepolizumab
Exclusion
- Chronic pulmonary pathology other than asthma
- Active neoplasia
- Active liver disease
- Serious and uncontrolled cardiovascular pathology (LVEF less than 30%, NYHA IV, ...)
- Other eosinophilic pathology (Churg \& Strauss syndrome, parasitic infection, ...)
- Hypersensitivity to mepolizumab or excipient
- Immunity disorders
- Patient not affiliated to a social security system
Key Trial Info
Start Date :
January 25 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2017
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03453021
Start Date
January 25 2016
End Date
October 31 2017
Last Update
October 3 2018
Active Locations (1)
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1
University Hospital Grenoble
La Tronche, France, 38700