NCT00392587已完成2 期
A Randomised, Double-blind, Placebo-controlled Parallel Study to Assess the Safety, Tolerability,Pharmacodynamics and Steady State Pharmacokinetics of Repeated Doses of GW856553 in Patients With COPD
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Measurements of adverse events, changes in heart rate, blood pressure, blood tests, heart function and lung function throughout the 14 day study. Exacerbations of COPD over the 14 day study.
研究概览
简要总结
The purpose of this study is to assess the safety of GW856553 in COPD patients and to assess its affects on their COPD disease after 14 days.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women of childbearing potential
- •Established history of COPD
- •Cigarette smoking history greater than 10 pack years
- •FEV1 between 40 and 80% of predicted normal for height, age and sex.
排除标准
- •Morbidly obese patients (body mass index >40)
- •Hospitalisation or treatment for worsening of COPD in past 6 weeks
- •History of increased liver function tests
- •hypersensitivity to salbutamol or ipratropium bromide
- •Blood pressure > 155/95
结局指标
主要结局
Measurements of adverse events, changes in heart rate, blood pressure, blood tests, heart function and lung function throughout the 14 day study. Exacerbations of COPD over the 14 day study.
时间窗: 14 days
次要结局
- Concentration of the drug in the blood after 1, 3, 7, 10 and 14 days of dosing.(after 1, 3, 7, 10 and 14 days of dosing)
- Inhibition of inflammatory agents in the blood after 7 and 14 days of dosing.(after 7 and 14 days of dosing)
研究者
研究点 (4)
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