NCT00913328已完成4 期
Effect of Add-on Montelukast to Inhaled Corticosteroids in Excessive Airway Narrowing in Adults With Asthma
适应症
干预措施
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
- Changes from baseline in maximal FEV1 decline at the dose-response plateau
研究概览
简要总结
Leukotriene receptor antagonists appear to posses additive anti-inflammatory effects to the effect of inhaled corticosteroids.
Hypothesis: Treatment with oral montelukast will lower the dose-response plateau to inhaled methacholine in patients with mild to moderate persistent asthma treated with a stable dose of inhaled corticosteroids.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-smoking adults with mild to moderate persistent asthma:
- •FEV1 > 70 % pred
- •PD20 methacholine < 3.9 mmol
- •treated for at least 3 months with a stable dose of inhaled corticosteroids
- •Documented dose-response plateau to inhaled methacholine on two occasions
- •Males and non-pregnant females
排除标准
- •Asthma medication other than inhaled corticosteroids and inhaled b2-agonists
- •Viral respiratory tract infections within the 3 weeks prior to enrollment
研究组 & 干预措施
Montelukast
Active Comparator
Oral montelukast 10 mg once daily for 12 weeks
干预措施: Montelukast (Singulair) (Drug)
Placebo
Placebo Comparator
Oral placebo once daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Changes from baseline in maximal FEV1 decline at the dose-response plateau
时间窗: After 12 weeks of treatment
次要结局
- Changes from baseline in PD20 methacholine(After 12 weeks of treatment)
研究者
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