A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study Evaluating the Effects of 2 Different Regimens of Montelukast (Daily Dosing and Intermittent, Episode-Driven Dosing) Compared With Placebo in the Treatment of Episodic Asthma in Children Aged 6 Months to 5 Years
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,771
- 主要终点
- Number of Asthma Episodes Culminating in Asthma Attack Over the 1-year Treatment Period
研究概览
简要总结
This is a year-long study evaluating the efficacy of both daily and intermittent treatment of asthma in children who experience symptoms episodically (i.e., seasonally, usually in the context of upper respiratory tract infection).
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
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 6 months to 5 years with episodic (periodic) asthma
排除标准
- •Patients who are not in otherwise good health
- •Patients who have persistent asthma (continual asthma symptoms)
研究组 & 干预措施
Arm 1: drug + episodic supplemental placebo
Montelukast once a day (qd) + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period
干预措施: montelukast sodium (Drug)
Arm 2: placebo comparator + episodic supplemental drug
Placebo qd + episode driven supplemental Montelukast qd for 12 days for a 52-wk treatment period
干预措施: montelukast sodium (Drug)
结局指标
主要结局
Number of Asthma Episodes Culminating in Asthma Attack Over the 1-year Treatment Period
时间窗: 1-year treatment period
The rate per year of asthma episodes culminating in an asthma attack for each of the 3 treatment groups. Asthma attacks were defined as respiratory symptoms requiring healthcare resource utilization (HRU), which comprised unscheduled visits to a physician or emergency department, treatment with corticosteroids (oral, rectal, or inhaled), or hospitalization. Each day during an episode, the patient's legal guardian recorded all the HRU that was required specifically for breathing problems.
次要结局
- Daily Average of Wheeze and Difficulty Breathing in the 3 Days Prior to Start of an Asthma Attack Within an Asthma Episode(1 Year)
- Daily Average of the Mean Symptom Scores (Wheeze, Difficulty Breathing, Interference With Activity, and Daytime Cough) Assessed Over the 12-day Treatment Period of Asthma Episodes(1 Year)