A Randomised Double-blind, Double-dummy Parallel Group Study to Compare the Efficacy and Safety of Fluticasone Propionate / Formoterol Fumarate (Flutiform®) 500/20 µg BID and 250/10 µg BID Versus Salmeterol / Fluticasone (Seretide®) 50/500 µg BID in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 923
- 主要终点
- Average pre-dose FEV1
研究概览
简要总结
The purpose of this study is to investigate whether flutiform® is effective and safe in the treatment of chronic obstructive pulmonary disease (COPD).
详细描述
A multi-centre, randomised, double-blind, double dummy, active-controlled, parallel-group study in male and female subjects conducted to assess the efficacy and safety of flutiform in the treatment of COPD. Subjects will be randomised to one of three treatment groups in a 1:1:1 ratio. Throughout the study subjects will be assessed on a mixture of symptom based and lung function measurements to monitor their progress in the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 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
Flutiform 500/20 µg BID
Flutiform 250/10 (2 puffs BID)
干预措施: Flutiform 500/20 µg BID (Drug)
Flutiform 250/10 µg BID
Flutiform 125/5 (2 puffs BID)
干预措施: Flutiform 250/10 µg BID (Drug)
Seretide Accuhaler 50/500 µg BID
Seretide Accuhaler 50/500 (BID)
干预措施: Seretide Accuhaler 50/500 µg BID (Drug)
结局指标
主要结局
Average pre-dose FEV1
时间窗: 26 weeks
次要结局
- Average 1 hour Post dose FEV1, FVC, FEV6(26 Weeks)