NCT00358488已完成2 期
A Multi-enter, Randomized, Double-blind, Placebo-controlled, Four-way Incomplete Block Crossover Study to Examine Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Repeat Administration of Three Inhaled Doses (10, 15, and 20 mcg) of GSK159797
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Mean change from baseline in trough FEV1
研究概览
简要总结
This study is designed to determine the efficacy and safety of a new long-acting beta-agonist for asthma patients (GSK159797) following dosing for 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 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
GSK159797 (10, 15, and 20mcg)
Experimental
GSK159797 (10, 15, and 20mcg)
干预措施: GSK159797 (10, 15, and 20mcg) (Drug)
salbutamol
Experimental
salbutamol
干预措施: salbutamol (Drug)
salmeterol 50mcg
Experimental
salmeterol 50mcg
干预措施: salmeterol 50mcg (Drug)
placebo
Placebo Comparator
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Mean change from baseline in trough FEV1
时间窗: after 14 day repeat doses
次要结局
- Mean change from baseline in trough FEV1(after 7 days repeat dosing)
- Change from baseline in weighted mean FEV1 0-2 hours, 0-4 hours, 0-24 hours(Day 1 and Day 14)
研究者
研究点 (1)
Loading locations...
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