NCT00289874已完成3 期
A Multicenter, Double-Blind, Placebo Controlled, Randomized, Parallel-Group Study to Evaluate the Clinical Effect of Oral Montelukast Versus Placebo in Persistent Asthma Which is Also Active During Allergy Seasons in Pediatric Patients With Seasonal Aeroallergen Sensitivity
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 421
- 主要终点
- Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3
研究概览
简要总结
This is a 3-week study to evaluate FEV1 following treatment with drugs in persistent asthma which is also active during allergy seasons in pediatric patients with seasonal aeroallergen sensitivity.
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 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients, ages 6 to 14 years, with persistent asthma that is also active during allergy season
- •Patients must demonstrate positive skin prick tests to seasonally relevant geographic aeroallergens
排除标准
- •Patient cannot have any other acute or chronic pulmonary disorder
研究组 & 干预措施
1
Experimental
montelukast
干预措施: montelukast sodium (Drug)
结局指标
主要结局
Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3
时间窗: Baseline and week 3
Percent change from baseline in FEV1, a measure of airway function, at Week 3
次要结局
- Percent Change From Baseline in Mean Daily "as Needed" β-agonist Use Over the 3-week Treatment Period(Baseline and Week 3)
研究者
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