A Phase Ib Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Bronchodilatory Effect of MK0476 in Patients With Chronic Asthma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 68
- 主要终点
- Change From Baseline in FEV1 Over 4 Hours
研究概览
简要总结
This study will test the safety and effectiveness of a range of doses of MK0476 (montelukast) compared to placebo on improved lung function in patients with chronic asthma.
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
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A person is 15 to 65 years of age. A person has had chronic asthma for at least one year
排除标准
- •A person is a smoker or has smoked more that a pack a day for more than 10 years before stopping
- •A person has other lung disorders such as COPD (chronic obstructive pulmonary disorder)
研究组 & 干预措施
1
montelukast Placebo
干预措施: Comparator: placebo (Drug)
1
montelukast Placebo
干预措施: Comparator: montelukast (Drug)
4
montelukast
干预措施: Comparator: montelukast (Drug)
3
montelukast
干预措施: Comparator: montelukast (Drug)
2
montelukast
干预措施: Comparator: montelukast (Drug)
结局指标
主要结局
Change From Baseline in FEV1 Over 4 Hours
时间窗: 0 (=baseline) to 4 hours after treatment with montelukast
FEV1 measurements taken at 0 (=baseline), 10, 20, 30, 45, 60, 120, 180 and 240 minutes contributed to the average change from baseline over 4 hours. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.
次要结局
- Change From Baseline in FEV1 Over 90 Minutes After Albuterol/Placebo Administration(4 hours (equals time point at which albuterol or albuterol placebo is administered) to 5.5 hours after treatment with montelukast)