NCT00559546已完成4 期
Montelukast as a Controller of Atopic Syndrome
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
- 61
- 试验地点
- 1
- 主要终点
- Allergic symptoms
研究概览
简要总结
The purpose of the study is to find out if montelukast can be used to treat the various symptoms of allergic syndrome.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Wheal diameter at least 4 mm in skin-prick test for both birch and timothy
- •Allergic symptoms in both upper airways (allergic rhinitis) and lower airways (asthma-like symptoms or diagnosed asthma) and at least one of the following:
- •Allergic conjunctivitis
- •Atopic eczema
- •Oral symptoms from vegetables or fruits by cross reactivity to birch
- •Urticaria in allergen exposure
排除标准
- •Need for regular treatment with glucocorticoids
- •Current smoking
- •Other major disease or need for regular drug treatment
- •Pregnancy
研究组 & 干预措施
1
Active Comparator
3 weeks of Montelukast and 3 weeks of placebo treatment
干预措施: montelukast (Drug)
2
Active Comparator
3 weeks of placebo and 3 weeks of montelukast treatment
干预措施: montelukast (Drug)
结局指标
主要结局
Allergic symptoms
时间窗: 3 weeks
次要结局
- Need for antihistamines or inhaled beta-2-agonists to relieve symptoms(3 weeks)
- Exhaled nitric oxide concentration(3 weeks)
研究者
研究点 (1)
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