Asthma Clinical Trial
Official title:
An Efficacy and Safety Study of Reslizumab in the Treatment of Poorly Controlled Asthma in Subjects With Eosinophilic Airway Inflammation
The purpose of this study is to determine the effectiveness and safety of reslizumab (the drug under study) in the treatment of subjects with poorly controlled asthma.
Objectives:
Primary: To demonstrate the ability of reslizumab to improve asthma control in subjects with
active asthma and eosinophilic airway inflammation.
Secondary:
- To study the ability of reslizumab to reduce induced sputum eosinophil (EOS) counts in
subjects with asthma.
- To study the ability of reslizumab to reduce the number of eosinophilic clinical asthma
exacerbations (CAE) in subjects with asthma. A CAE is defined as a ≥ 20% decrease in
FEV1 (absolute value) from the baseline value or a requirement for emergency treatment
of asthma, hospital admission for asthma or treatment with three or more days of oral
corticosteroids (OCS) for asthma worsening.
- To assess the safety and tolerability of reslizumab in subjects with asthma.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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