NCT00157937已完成4 期
A Randomized, Open Label, Cross-Over Study Comparing Effectiveness for the Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 主要终点
- FEV1
研究概览
简要总结
Subjects have 8-week with montelukast sodium or comparator drug administration period, 2-week wash-out period and 8-week comparator drug or the drug administration period (with cross-over design) for assessment of the drug efficacy, safety and tolerability.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females between the ages of 18 and 60 with mild to moderate asthma
排除标准
- 未提供
结局指标
主要结局
FEV1
次要结局
- AM-PEFR; daytime symptom score; treatment frequency of beta agonist; global assessment investigator's symptom assessment; Quality of Life Questionnaire for Adult Korean Asthmatics; QLQAKA
研究者
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