A Multicenter, Randomized, Double-Blind, Parallel-Group 6-Month Study to Evaluate the Efficacy and Safety of Oral Montelukast Sodium, Fluticasone Propionate and Placebo in Patients With Chronic Asthma Who Smoke Cigarettes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,640
- 主要终点
- Percentage of Asthma-control Days Over the 6-month Treatment Period
研究概览
简要总结
This is a multicenter study to evaluate the efficacy and safety of MK0476 versus placebo in participants with chronic asthma who actively smoke cigarettes.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with chronic asthma who actively smoke at least 0.5 to no more than 2 packs of cigarettes a day
排除标准
- •Participant cannot have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or emphysema.
研究组 & 干预措施
1
Arm 1: Montelukast
干预措施: montelukast sodium (Drug)
结局指标
主要结局
Percentage of Asthma-control Days Over the 6-month Treatment Period
时间窗: 6 months
An asthma-control day, computed from daily diaries, was any day with no unscheduled visit for asthma care, no use of \> than 2 puffs of β-agonist, no use of other asthma rescue medication, and no nocturnal awakening. The percentage of asthma-control days was the number of days with asthma-control divided by the total number of days with non-missing values for this endpoint. The patient diary had questions concerning daytime and nighttime symptoms, morning (AM) and evening (PM) peak expiratory flow rate (PEFR), β-agonist use, asthma attacks and smoking activity.
次要结局
- Change From Baseline in Average Morning (AM) PEFR (Peak Expiratory Flow Rate) Over a 6-month Treatment Period(Baseline and 6 months)
- Change From Baseline in Mean Daytime Symptom Score Over a 6-month Treatment Period(Baseline and 6 months)