A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of Montelukast in Patients With Seasonal Allergic Rhinitis Over a 4-Week Treatment Period-Fall 2001
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,079
- 主要终点
- Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period
研究概览
简要总结
This is a study to evaluate the treatment effect of montelukast 10 mg taken in the morning, versus placebo, in patients with seasonal allergic rhinitis. 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 history of seasonal allergic rhinitis that worsens during the study season
- •Patient is a nonsmoker
- •Patient is in good health physical and mental health
排除标准
- •Patient is hospitalized
- •Patient is a woman who is < 8 weeks postpartum or is breastfeeding
- •Patient plans to move or vacation away during the study
- •Patient has had any major surgery with in past 4 weeks
- •Patient is a current or past abuser of alcohol or illicit drugs
研究组 & 干预措施
1
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 Over First 2 Weeks of Treatment Period
时间窗: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)
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 \[Score 0 (best) to 3 (worse)\]. 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 Over First 2 Weeks of Treatment Period(Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2))
- Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period(Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2))
- Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period(Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2))
- Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment(After first 2 weeks of treatment)
- Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment(After first 2 weeks of treatment)
- Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period(Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2))