NCT00960141已完成3 期
A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of Montelukast in Patients With Seasonal Allergic Rhinitis-Fall Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 829
- 主要终点
- Mean Change From Baseline in Daytime Nasal Symptoms Score
研究概览
简要总结
A study of the ability of montelukast to improve signs and symptoms of seasonal allergic rhinitis compared with placebo. Loratadine is included in the study as an active control.
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 clinical history of seasonal allergic rhinitis symptoms that become worse during the study season
- •Patient is a non-smoker
- •Patient is in good mental and physical health
排除标准
- •Patient is hospitalized
- •Patient is a woman who is <8 weeks postpartum or is breast feeding
- •Patient intends to move or vacation away during the study
- •Patient is a current or past abuser of alcohol or illicit drugs
研究组 & 干预措施
1
Experimental
montelukast
干预措施: montelukast sodium (Drug)
结局指标
主要结局
Mean Change From Baseline in Daytime Nasal Symptoms Score
时间窗: Baseline and Week 2
Mean change from baseline in Daytime Nasal Symptoms score on a 4-point scale \[0(best) to 3(worst)\]. The average of the 4 individual nasal symptoms scores (Congestion, Rhinorrhea, Itching, and Sneezing) was reported as the Daytime Nasal Symptoms Score.
次要结局
- Mean Change From Baseline in Nighttime Symptoms Score(Baseline and Week 2)
- Mean Change From Baseline in Daytime Eye Symptoms Score(Baseline and Week 2)
- Patient's Global Evaluation of Allergic Rhinitis(Week 2 (or upon discontinuation))
- Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score(Baseline and Week 2)
- Physician's Global Evaluation of Allergic Rhinitis(Week 2)
研究者
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