Safety and Efficacy of Bepotastine Besilate Nasal Spray in the Treatment of Seasonal Allergic Rhinitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 601
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline (Pre-Dose) in Subject-rated Reflective TNSS
研究概览
简要总结
This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female at least 12 years of age with a history of mountain cedar allergy
排除标准
- •No active nasal infection or nasal abnormality that would affect subject safety or symptom assessments
研究组 & 干预措施
2% Twice a day
Bepotastine Besilate Nasal Spray 2% Twice a day
干预措施: Bepotastine Besilate Nasal Spray 2% Twice a day (Drug)
3% Twice a day
Bepotastine Besilate Nasal Spray 3% Twice a day
干预措施: Bepotastine Besilate Nasal Spray 3% Twice a day (Drug)
4% Twice a day
Bepotastine Besilate Nasal Spray 4% Twice a day
干预措施: Bepotastine Besilate Nasal Spray 4% Twice a day (Drug)
Placebo
Placebo nasal spray
干预措施: Placebo Nasal Spray (Drug)
结局指标
主要结局
Mean Change From Baseline (Pre-Dose) in Subject-rated Reflective TNSS
时间窗: Baseline, 14 days
Total nasal symptom score (TNSS) was the summed scores for nasal pruritus \[itching\], rhinorrhea \[runny nose\], nasal congestion, and sneezing. Individual nasal symptoms were each rated on a 4-point scale from 0-3 (0=Absent, 1=Mild, 2=Moderate, 3=Severe), with no half-unit assessments. TNSS was the sum score of 4 nasal symptoms with a minimum score of 0 units and a maximum score of 12 units, with higher score corresponding to increased nasal allergy symptoms. Morning and evening scores were averaged.
次要结局
未报告次要终点