Efficacy and Safety of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride in Perennial Allergic Rhinitis (PAR) Patients : A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 283
- 试验地点
- 1
- 主要终点
- Mean Daytime Nasal Symptom Score
研究概览
简要总结
The purpose of this study is to demonstrate that the efficacy of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride is superior to that of Levocetirizine and Montelukast monotherapies and to compare the safety and tolerability of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride to those of Levocetirizine and Montelukast monotherapies in Perennial Allergic Rhinitis (PAR) patients.
详细描述
randomized, double-blind, active-controlled, multicenter, phase 3 trial
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with at least 2 years history of PAR prior to the study
- •Positive results of skin prick test
- •Patients who provided a signed written informed consent form
- •Patients who are able and willing to complete subject diaries
- •Patients who agree to maintain consistency in their surroundings throughout the study period
- •At Visit, 2 patients whose symptom scores recorded in the subject diary meet all of the followings during the last one week of baseline period A.Daily mean of 6 points or above for Daytime Nasal Symptom Score (maximum 12 points) B.Daily mean of 1.8 points or above for Daytime Nasal Obstruction Symptom Score (maximum 3 points)
排除标准
- •Patients also with non-allergic rhinitis with different causes.
- •Patients with severe asthma who meet the followings.
- •Presence of nasal polyps or any clinically important nasal anomaly.
- •History of acute • chronic sinusitis within 30 days of Visit 1
- •History of intranasal / eye surgeries within 3 months of Visit 1
- •Initiation of immunotherapy or dose modification within 1 month prior to Visit 1
- •Upper respiratory infections including cold and systemic infections within 3 weeks of Visit
- •Chronic use of tricyclic antidepressants, beta agonists, bronchodilators, etc. that may affect the efficacy of study drug
- •At Visit 2, patients who recorded Daytime Nasal Symptom Scores for fewer than 4 days in the subject diary during the last one week of baseline period
研究组 & 干预措施
Test arm
Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg
干预措施: Montelukast + Levocetirizine (Drug)
Comparator arm I
Matching placebo of Montelukast sodium 10mg + Levocetirizine dihydrochloride 5 mg
干预措施: Levocetirizine (Drug)
Comparator arm II
Montelukast sodium 10mg + matching placebo of Levocetirizine dihydrochloride 5mg
干预措施: Montelukast (Drug)
结局指标
主要结局
Mean Daytime Nasal Symptom Score
时间窗: 4 weeks
Change in Mean Daytime Nasal Symptom Score from baseline at Weeks 3-4(2 weeks) of treatment
次要结局
- Change in Mean Nighttime Nasal Symptom from baseline at Weeks 1-2 (2 weeks) and Weeks 3-4 (2 weeks) of treatment(4 weeks)
- Mean Composite Symptom Score(4 weeks)