A Multi-Center, Randomized, Double-Blind, Parallel-Group, Dose-Finding Trial to Evaluate the Safety and Efficacy of Fluticasone Propionate Combined With Formoterol Fumarate in Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 457
- 试验地点
- 1
- 主要终点
- 2-hour post-dose FEV1
研究概览
简要总结
The purpose of the study is to determine the appropriate dose of fluticasone propionate/formoterol fumarate that is closest to Advair Diskus (fluticasone propionate/salmeterol xinafoate using pulmonary function, safety, and levels of study drug in blood plasma in patients with chronic obstructive pulmonary disease.
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
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
- •Diagnosis of COPD
- •Female of child-bearing potential to use adequate birth control
- •Smoker or ex-smoker with history of at least 10 years of smoking at least one pack of cigarettes per day
- •Meet lung function requirements
排除标准
- •Diagnosis of asthma
- •Other significant disease than COPD
- •Pregnant or lactating female
- •Female planning to become pregnant
研究组 & 干预措施
C 10/1
干预措施: Fluticasone Propionate/Formoterol Fumarate (Drug)
C 5/2
干预措施: Fluticasone Propionate/Formoterol Fumarate (Drug)
C 5/1
干预措施: Fluticasone Propionate/Formoterol Fumarate (Drug)
FP 1000
干预措施: Fluticasone Propionate (Drug)
FF 20
干预措施: Formoterol Fumarate (Drug)
AD 250/50
干预措施: Fluticasone Propionate/Salmeterol Xinafoate (Drug)
Plc
干预措施: Placebo (Drug)
C 10/2
干预措施: Fluticasone Propionate/Formoterol Fumarate (Drug)
结局指标
主要结局
2-hour post-dose FEV1
时间窗: 2 weeks
AUC(0-12) and Cmax in plasma
时间窗: 2 weeks
pre-dose FEV1
时间窗: 2 weeks
Amount and percent total dose excreted in urine
时间窗: 2 weeks
次要结局
- FEV1 AUC(0-2)(2 weeks)
- COPD exacerbations
- Treatment Emergent Adverse Events(2 weeks)