A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of Combination Montelukast/Loratadine in Patients With Seasonal Allergic Rhinitis-Fall Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 907
- 主要终点
- Mean Change From Baseline in Daytime Nasal Symptoms Score
研究概览
简要总结
This study will evaluate the ability of oral montelukast/loratadine to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine alone, montelukast alone 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
- •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
- •Patient has any active pulmonary disorder other than asthma
研究组 & 干预措施
1
montelukast/loratadine
干预措施: Comparator: montelukast/loratadine (Drug)
4
placebo
干预措施: Comparator: placebo (Drug)
3
montelukast
干预措施: Comparator: montelukast (Drug)
2
loratadine
干预措施: Comparator: loratadine (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. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale (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
- Physician's Global Evaluation of Allergic Rhinitis(Week 2)
- Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score(Week 2)
- Mean Change From Baseline in Nighttime Symptoms Score(Baseline and Week 2)
- Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms)(Baseline and Week 2)
- Mean Change From Baseline in Daytime Nasal Congestion Score(Baseline and Week 2)
- Mean Change From Baseline in Daytime Eye Symptoms Score(Baseline and Week 2)
- Mean Change From Baseline in Daytime Rhinorrhea Score(Baseline and Week 2)
- Mean Change From Baseline in Daytime Nasal Itching Score(Baseline and Week 2)
- Mean Change From Baseline in Daytime Sneezing Score(Baseline and Week 2)
- Mean Change From Baseline in Nasal Congestion Upon Awakening(Baseline and Week 2)
- Patient's Global Evaluation of Allergic Rhinitis(Week 2)