Conditions: Eosinophilic Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 315
Healthy volunteers: no

Brief summary:
The primary objective of this study is to determine whether reslizumab, at a dosage of 0.3 or 3.0 mg/kg administered once every 4 weeks for a total of 4 doses, is more effective than placebo in improving lung function in patients with eosinophilic asthma as assessed by the overall change from baseline in forced expiratory volume in 1 second (FEV1).

Detailed description:

Arms:
arm 1: Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses. arm 2: 0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses arm 3: 3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.

Interventions: intervention 1: Reslizumab intervention 2: Placebo
Intervention descriptions: intervention 1: 3.0 mg/kg or 0.3 mg/kg doses administered intravenously (iv) by qualified site personnel once every 4 weeks, for a total of 4 doses. intervention 2: Placebo administered by iv infusion by qualified study personnel every 4 weeks for a total of 4 doses.

Protocol document: