NCT00395408已完成4 期
A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing the Effect on Linear Growth of Montelukast With Placebo and Inhaled Beclomethasone in Pediatric Patients (Prepubertal, Tanner Stage I) With Mild Asthma
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 360
- 主要终点
- To establish the difference in the average rate of linear growth over the 56-week double-blind treatment period between the montelukast and placebo groups
研究概览
简要总结
The purpose of this study is to compare the effect of montelukast with placebo and beclomethasone on the average rate of linear growth over a period of 56 weeks in children with mild asthma.
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
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
To establish the difference in the average rate of linear growth over the 56-week double-blind treatment period between the montelukast and placebo groups
次要结局
- Discontinuations due to asthma
- Peripheral blood eosinophil count
- Oral corticosteroid rescues for asthma
- Markers of bone turn-over
- To evaluate the effects of montelukast in comparison with placebo and beclomethasone on FEV1
- Beta-agonist use
研究者
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