NCT00354042已完成1 期
A Randomised, Double-Blind, Placebo-Controlled, Dose Ascending, 4 Period Crossover Study to Examine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Repeat Inhaled Doses of GW597901X in Asthmatic Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Safety Tolerability including blood test results, effects on the heart, pulse rate and blood pressure, and any side effects.
研究概览
简要总结
This study is designed to look at the safety aspects and effects of repeat inhaled doses of GW597901X in asthmatics to develop this drug for its use in asthma and Chronic Obstructive Pulmonary Disease(COPD).
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with mild to moderate stable asthma but no other lung problems.
- •Male subjects or female subjects who are not able to get pregnant (e.g. post-menopausal or surgically sterile).
- •Non-Smokers.
- •Subjects who show a measurable improvement in the function of their lungs after a single dose of salbutamol.
排除标准
- •Any significant illness.
- •Subjects with heart problems.
- •Subjects who have a cold or chest infection 2-4 weeks prior to the study or have life-threatening asthma.
- •Subjects who take medication for their asthma, or other conditions, not compatible with this study.
- •Subjects who are over sensitive to salbutamol or to ipratropium.
结局指标
主要结局
Safety Tolerability including blood test results, effects on the heart, pulse rate and blood pressure, and any side effects.
次要结局
- Effects on the lungs at 12 and 24 hours Effects on the heart, blood pressure and heart rate at 8 hours Effects on blood tests over 4 hours and 8 hours Reduction of rescue medication.
研究者
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