A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3b Study to Evaluate the Onset of Effect and Time Course of Change in Lung Function With Benralizumab in Severe, Uncontrolled Asthma Patients With Eosinophilic Inflammation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 233
- 试验地点
- 1
- 主要终点
- Change From Baseline (Visit 4) to Day 28 (Visit 8), Day 56 (Visit 9), and Day 84 (Visit 10) in Pre-BD FEV1
研究概览
简要总结
The purpose of this study is to investigate the onset and maintenance of effect of benralizumab on lung function, blood eosinophils, asthma control metrics and quality of life during 12-week treatment in patients with uncontrolled, severe asthma with eosinophilic inflammation. A subset of patients will take part in body plethysmography substudy to further investigate the effect on lung function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Benralizumab arm
Benralizumab administered subcutaneously
干预措施: Benralizumab (Drug)
Placebo arm
Placebo administered subcutaneously
干预措施: Placebo (Other)
结局指标
主要结局
Change From Baseline (Visit 4) to Day 28 (Visit 8), Day 56 (Visit 9), and Day 84 (Visit 10) in Pre-BD FEV1
时间窗: From first IP dose to Day 84
The average over the mean differences between benralizumab and placebo for change from baseline in pre-BD FEV1 is used to determine if the study is positive and to determine maintenance of effect. The first post baseline time point where the p-value for the mean difference between benralizumab and placebo is less than or equal to 0.05 is used to determine time to onset of effect.
Change From Baseline (Visit 4) to End of Treatment Day 84 (Visit 10) in Residual Volume (RV)
时间窗: From first IP dose to Day 84
Body plethysmography was performed for sub-study patients. Lung volume subdivisions measures were performed by the investigator or qualified designee according to ATS/ERS guidelines.
次要结局
- Percentage of Pre-BD FEV1 Responder(From first IP dose to Day 84)
- Change From Baseline to Post Baseline for Pre-BD FVC(From first IP dose to Day 84)
- Change From Baseline to End of Treatment in FeNO(From first IP dose to Day 84)
- Change From Baseline to End of Treatment in Ratio of Residual Volume (RV) and Total Lung Capacity (TLC) for Sub-study Patients(From first IP dose to Day 84)
- Change From Baseline to End of Treatment in Inspiratory Capacity (IC) for Sub-study Patients(From first IP dose to Day 84)
- Change From Baseline to End of Treatment in Functional Residual Capacity (FRC) for Sub-study Patients(From first IP dose to Day 84)
- Change From Baseline to End of Treatment in Vital Capacity (VC) for Sub-study Patients(From first IP dose to Day 84)
- Duration of IP Administration(From first IP to last IP)
- Percent Change From Baseline to End of Treatment in Eosinophils Counts(From first IP dose to Day 84)
- Change From Baseline (Visit 4) to Post Baseline Visits in Pre-BD FEV1(From first IP dose to Day 84)
- Change From Baseline in St. George's Respiratory Questionnaire (SGRQ)(From first IP dose to Day 84)
- Change From Baseline to End of Treatment in Total Lung Capacity (TLC) for Sub-study Patients(From first IP dose to Day 84)
- Change From Baseline in ACQ-6(From first IP dose to Day 84)