NCT00974571已完成3 期
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis
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
- 1,365
- 主要终点
- Mean Change From Baseline in Daytime Nasal Symptoms Score
研究概览
简要总结
This study will assess the ability of montelukast to improve the signs and symptoms of perennial allergic rhinitis compared to placebo. Cetirizine 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 perennial allergic rhinitis
- •Patient is a nonsmoker
- •Patient is in good general health
排除标准
- •Patient is hospitalized
- •Patient is a woman who is <8 weeks postpartum or is breast-feeding
- •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 first 4 weeks of a 6-week treatment period
Mean change from baseline in Daytime Nasal Symptoms score. Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale \[Score 0 (best) to 3 (worst)\]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.
次要结局
- Mean Change From Baseline in Nighttime Symptoms Score(Baseline and first 4 weeks in 6-week treatment period)
- Physician's Global Evaluation of Allergic Rhinitis(End of the first 4 weeks in 6-week treatment period)
- Mean Change From Baseline in Composite Symptoms Score(Baseline and first 4 weeks in 6-week treatment period)
- Patient's Global Evaluation of Allergic Rhinitis(End of the first 4 weeks in 6-week treatment period)
研究者
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