A Multi-centre, Randomised, Double-blind, Placebo Controlled, Dose Ascending, Four Way Crossover Study to Examine Efficacy (FEV1), Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Repeat Doses of GW642444
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- FEV1 at 24 hours after a single dose.
研究概览
简要总结
This study will evaluate efficacy (FEV1), safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat inhaled doses of GW642444. This will be a multi-centre, double-blind, placebo controlled, dose ascending, four way cross-over study in approximately 28 mild to moderate asthmatic subjects.
Key assessments: Efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics will be assessed by measurement of FEV1, blood pressure, heart rate, 12-lead ECGs, clinical laboratory tests, collection of adverse events (AE) information and blood samples.
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
- 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
GW642444 50mcg
干预措施: GW642444 (Drug)
GW642444 100mcg
干预措施: GW642444 (Drug)
GW642444 200mcg
干预措施: GW642444 (Drug)
salmeterol 50mcg
干预措施: salmeterol 50mcg (Drug)
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
FEV1 at 24 hours after a single dose.
时间窗: 24 hours on 4 separate occasions
次要结局
- FEV1 - Days 1 and 7(Days 1 and 7 on 4 separate occasions)
- BP, HR & QTc on Days 1 and 7(Days 1 and 7 on 4 separate occasions)
- Mean morning/evening PEFR(Days 3-8 on 4 separate occasions)
- Potassium and glucose on Days 1 and 7(Days 1 and 7 on 4 separate occasions)
- safety & tolerability as measured by AEs, laboratory safety tests, cardiac monitoring, VS & ECG(throughout study)
- PK parameters(Days 1, 4 and 7 on 4 separate occasions)