NCT00979901已完成3 期
A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Seasonal Allergic Rhinitis--Spring Study
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,577
- 主要终点
- Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks
研究概览
简要总结
This study will evaluate the ability of montelukast to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine and placebo.
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
- 15 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has a documented history of seasonal allergic rhinitis symptoms that flare up during the study season
- •Patient is a nonsmoker and has been a nonsmoker for at least 1 year
- •Patient is in good general health
排除标准
- •Patient is hospitalized
- •Patient is a woman who is less than 8 weeks postpartum or is breast-feeding
- •Patient intends to move or vacation away during the study
- •Patient has had any major surgery within 4 weeks of study start
- •Patient is a current or past abuser of alcohol or illicit drugs
- •Patient has been treated in an emergency room for asthma in the past month
- •Patient had an upper respiratory infection with in 3 weeks prior to study start
结局指标
主要结局
Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks
时间窗: Baseline and Week 2
Mean change from baseline in Daytime Nasal Symptoms score. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score. Scores were measured as 0 (best) to 3 (worst).
次要结局
- Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks(Baseline and Week 2)
- Physician's Global Evaluation of Allergic Rhinitis at Week 2(Week 2)
- Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks(Baseline and Week 2)
- Patient's Global Evaluation of Allergic Rhinitis at Week 2(Week 2)
- Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2(Week 2)
研究者
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