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A 12-Month Double-Blind Placebo-Controlled Parallel-Group Study to evaluate the Efficacy and Safety of Reslizumab 30 mgkg in the reduction of Clinical Asthma Exacerbations in Patients 12-75 years of age with Eosinophilic Asthma

The primary objective of this study is to determine whether reslizumab at a dose of 3 mgkg administered intravenously iv every 4 weeks over 12 months is more effective than placebo in reducing the number of clinical asthma exacerbations CAEs in patients with eosinophilic asthma as assessed by the frequency of CAEs A CAE is defined by one of the following: 1 a hospitalization because of asthma 2 emergency treatment because of asthma 3 a decrease in forced expiratory volume in 1 second FEV1 by 20 or more or 4 a decrease in peak expiratory flow rate PEFR of 30 or more in 2 consecutive measurements Emergency treatment includes unscheduled visits to the physicians office for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms or a visit to the emergency room for treatment regardless of subsequent admission

FieldValue
Modified
2019-08-31
Release Date
2018-05-12
Identifier
05342791-460b-492b-8e29-3cd7fc67a107
License
Public Access Level
Public