NCT00092105已完成3 期
A Multicenter, Double-Blind, Randomized, Crossover Study Investigating the Clinical Effect of Montelukast in Patients With Concomitant Asthma and Allergic Rhinitis Upon Controlled Exposure to Cat Allergen
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 58
- 主要终点
- Co-Primary endpoints: (1) Area Under the Curve (AUC) for the percent fall from prechallenge FEV1 during allergen challenge; (2) Area Under the Curve for the increase from prechallenge Nasal Symptoms score during allergen challenge
研究概览
简要总结
The purpose of this study is to determine the protective effect of an approved medication on asthma and allergic rhinitis (inflammation of the mucous membrane of the nose) upon exposure to cats.
详细描述
The duration of treatment is 2 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Increased sensitivity to cat allergen proven by positive allergy testing, and by decreased lung function and increased symptoms of allergic rhinitis (runny nose) upon exposure to cats.
排除标准
- •Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection.
结局指标
主要结局
Co-Primary endpoints: (1) Area Under the Curve (AUC) for the percent fall from prechallenge FEV1 during allergen challenge; (2) Area Under the Curve for the increase from prechallenge Nasal Symptoms score during allergen challenge
次要结局
- (1) Maximum percent fall from prechallenge FEV1; (2) AUC for the increase from prechallenge Chest Symptoms score (3) AUC for the increase from prechallenge Nasal Symptoms score collected over 60 minutes after terminating the challenge.
研究者
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