Castro 2015a.
Study characteristics | ||
Methods | Double‐blind, placebo‐controlled, parallel‐group study | |
Participants | 489 participants with moderate‐severe asthma (medium dose of ICS, inadequate control ACQ ≥ 1.5, and at least 1 exacerbation in the past 12 months)
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Interventions | IV infusion of reslizumab 3 mg/kg or matching placebo every 4 weeks (13 doses with last dose in week 48) | |
Outcomes | Primary outcomes (per protocol)
Secondary outcomes (per protocol)
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Notes | 128 clinical research centres. The research was funded by Teva Branded Pharmaceutical Products R&D. Teva employees were involved in the study design, data collection and analysis, and in the writing of this manuscript. All study authors had full access to all study data and had final responsibility for the decision to submit for publication. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was done with use of interactive response technology with computerised central randomisation. |
Allocation concealment (selection bias) | Low risk | The funder’s clinical personnel involved in the study were also masked to the study drug identity until the database was locked for analysis and the treatment assignment |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants and investigators remained masked to treatment assignment during the study |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Participants and investigators remained masked to treatment assignment during the study |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The withdrawal rates were relatively low and even across the groups (11%‐14%) |
Selective reporting (reporting bias) | Low risk | All primary and secondary outcome measures were reported. |