Double-blind, Placebo-controlled, 3-way Crossover Study to Investigate the Effect of 7-days Repeat Once Daily Inhaled Doses of GW870086X Administered Via DISKHALER on Airway Responsiveness to AMP in Mild Steroid-naive Male Asthmatics
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in lung function 2 hours after treatment on day 7
研究概览
简要总结
This study was designed to look at safety aspects and effects of repeat inhaled doses of GW870086X in mild 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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 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
Cohort 1: Part A
Subjects in Cohort 1 will be randomized to receive 0.5, 2 and 6 mg GW870086X and placebo.
干预措施: GW870086X (Drug)
Cohort 1: Part A
Subjects in Cohort 1 will be randomized to receive 0.5, 2 and 6 mg GW870086X and placebo.
干预措施: Placebo (Drug)
Cohort 2: Part A
Subjects in Cohort 2 will be randomized to receive 3 mg GW870086X or placebo.
干预措施: GW870086X (Drug)
Cohort 2: Part A
Subjects in Cohort 2 will be randomized to receive 3 mg GW870086X or placebo.
干预措施: Placebo (Drug)
Part B
Subjects will be randomized to receive 1 and 3 mg of GW870086X or placebo.
干预措施: GW870086X (Drug)
Part B
Subjects will be randomized to receive 1 and 3 mg of GW870086X or placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in lung function 2 hours after treatment on day 7
时间窗: on day 7
次要结局
- Change in lung function 14 and 26 hours after treatment on day 7; Change in lung function 2 hours after treatment on day 1; Effects on blood and urine tests; effects on the heart, pulse rate and blood pressure; effects on the lungs(2 hours after treatment on day 1, 14 and 26 hours after treatment on day 7;)