A Multicenter, Randomized, Double Blind, Crossover Study Comparing the Effect of MK0524 With Placebo and Concomitant Administration of MK0524 Plus Montelukast in Adult Patients With Chronic Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
- 主要终点
- To demonstrate benefits of MK0524 compared with placebo on Forced Expiratory Volume in 1 second (FEV1)
研究概览
简要总结
The purpose of the study is to demonstrate the benefit of MK0524 compared to placebo 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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has symptoms of chronic asthma (shortness of breath, wheezing, chest tightness, etc.) for at least 1 year
- •Nonsmoker for at least 1 year with a smoking history of no more than 7 pack-years (i.e., 1 pack per day for 7 years)
排除标准
- •Any clinically significant disease of heart, intestinal, kidney, liver, lung or uncontrolled blood pressure
- •Any surgery within 4 weeks prior to Visit 1
- •Patient is intending to move or vacation for more than 5 days during the study
- •Patient is pregnant or breast-feeding
研究组 & 干预措施
1
Treatment Sequence 1: MK0524 + placebo, MK0524 + montelukast, placebo, placebo, placebo + montelukast
干预措施: Comparator: MK0524 + placebo (Drug)
1
Treatment Sequence 1: MK0524 + placebo, MK0524 + montelukast, placebo, placebo, placebo + montelukast
干预措施: Comparator: MK0524 + montelukast (Drug)
1
Treatment Sequence 1: MK0524 + placebo, MK0524 + montelukast, placebo, placebo, placebo + montelukast
干预措施: Comparator: placebo + montelukast (Drug)
1
Treatment Sequence 1: MK0524 + placebo, MK0524 + montelukast, placebo, placebo, placebo + montelukast
干预措施: Comparator: Placebo (Drug)
2
Treatment sequence 2: Placebo, montelukast, placebo, MK0524, MK0524 + montelukast
干预措施: Comparator: MK0524 + placebo (Drug)
2
Treatment sequence 2: Placebo, montelukast, placebo, MK0524, MK0524 + montelukast
干预措施: Comparator: MK0524 + montelukast (Drug)
2
Treatment sequence 2: Placebo, montelukast, placebo, MK0524, MK0524 + montelukast
干预措施: Comparator: placebo + montelukast (Drug)
2
Treatment sequence 2: Placebo, montelukast, placebo, MK0524, MK0524 + montelukast
干预措施: Comparator: Placebo (Drug)
结局指标
主要结局
To demonstrate benefits of MK0524 compared with placebo on Forced Expiratory Volume in 1 second (FEV1)
时间窗: Last 2 weeks of each treatment period
次要结局
- To determine the benefits of MK0524 as compared with placebo on the key secondary endpoints (Daytime & Nighttime Asthma Symptoms scores(Last 2 weeks of each treatment period)