NCT01168310已完成2 期
A 12-week Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess the Pharmacodynamic Response of Fluticasone Propionate in Fixed-Dose Combination With Formoterol Fumarate in Subjects With COPD
Dey3 个研究点 分布在 1 个国家目标入组 468 人开始时间: 2010年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 468
- 试验地点
- 3
- 主要终点
- Change in forced expiratory volume at one second (FEV1) measured in milliliters by spirometry to assess pharmacodynamic response of fluticasone propionate in combination with formoterol fumarate in subject with COPD
研究概览
简要总结
This is a randomized, double-blind, multi-dose, parallel group trial which will assess the pharmacodynamic response of fluticasone propionate and formoterol fumarate in subjects with COPD.
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 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand the requirements of the study and provide written informed consent
- •A clinical diagnosis of COPD
- •A current or prior history of at least 10-pack years of cigarette smoking
- •Women of child-bearing potential (WOCBP) must have a negative pregnancy test at the screening visit and agree to avoid becoming pregnant for the duration of study
排除标准
- •A clinical diagnosis of Asthma
- •Other significant disease than COPD
- •Subjects who radiation or chemotherapy within the previous 12 months
- •Subjects who had any lung resection
- •QTcB greater than 0.460 seconds
- •History of illegal drug abuse or alcohol abuse within the past 5 years
研究组 & 干预措施
2
Experimental
干预措施: Fluticasone Propionate/Formoterol Fumarate (Drug)
3
Experimental
干预措施: Fluticasone Propionate/Formoterol Fumarate (Drug)
1
Experimental
干预措施: Fluticasone Propionate/Formoterol Fumarate (Drug)
4
Experimental
干预措施: Fluticasone Propionate/Formoterol Fumarate (Drug)
5
Experimental
干预措施: Fluticasone Propionate/Formoterol Fumarate (Drug)
6
Active Comparator
干预措施: Formoterol Fumarate (Drug)
7
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in forced expiratory volume at one second (FEV1) measured in milliliters by spirometry to assess pharmacodynamic response of fluticasone propionate in combination with formoterol fumarate in subject with COPD
时间窗: 12 Weeks
次要结局
- Incidence of adverse events (AEs)(12 Weeks)
研究者
研究点 (3)
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