A Multicenter, Randomized, Parallel-group, Placebo-controlled, 4-week Clinical Endpoint Bioequivalence Study Comparing Fluticasone Propionate/Salmeterol 100/50 µg Inhalation Powder With Advair® Diskus 100/50 µg in Asthma Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Cipla Ltd.
- 入组人数
- 1,366
- 试验地点
- 1
- 主要终点
- Area under the serial Force Expiration volume1 from time 0 to 12 hours (AUC0-12 hours)
研究概览
简要总结
The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in adult patients with asthma.
详细描述
This study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in terms of FEV1 measured at different time-points in adult patients with asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（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
Test
Fluticasone propionate/salmeterol 100/50 µg
干预措施: Fluticasone propionate/salmeterol 100/50 µg (Drug)
Comparator
Fluticasone propionate/salmeterol 100/50 µg
干预措施: Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUAT (Drug)
Placebo
Test Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Area under the serial Force Expiration volume1 from time 0 to 12 hours (AUC0-12 hours)
时间窗: one day
Area under the serial Force Expiration volume1 from time 0 to 12 hours (AUC0-12 hours) on the first day of the treatment
次要结局
未报告次要终点