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Mepolizumab for Prednisone-Dependent Eosinophilic Bronchitis
NCT00292877Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2005
- Primary completion
- Jun 2008
- Countries
- 1
- Sponsor
- St. Joseph's Healthcare Hamilton
- Modality
- Monoclonal Antibodies
- Drugs
- mepolizumab
- Conditions
- eosinophilic bronchitis (EB)asthma
01
Overview
Phase 2, randomised, double-blind trial in eosinophilic bronchitis (EB) and asthma comparing Mepolizumab with Placebo (2 arms). Primary endpoint: Prednisone-sparing effect. Started Jan 2005; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Mepolizumab
Mepolizumab 750mg IV + Prednisone taper
Placebo
Placebo IV + Prednisone taper
03
Endpoints
Primary
Prednisone-sparing effect
Secondary
Percentage of sputum eosinophils
Forced Expiratory Volume in 1 second
Methacholine PC20
Blood eosinophil count
Amount of rescue salbutamol use
Time to exacerbation
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