Safety, Pharmacokinetics, and Efficacy of Bepotastine Besilate Nasal Product After Ragweed Pollen Exposure in an Environmental Chamber
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline (Pre-Dose) in Subject-rated Instantaneous TNSS
研究概览
简要总结
The purpose of this study is to examine the safety and efficacy of bepotastine besilate nasal product in seasonal allergic rhinitis patients.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 18 to 65 years of age with a positive skin prick test with ragweed allergen
排除标准
- •No active respiratory tract infection
研究组 & 干预措施
Arm 1 - Low Dose
bepotastine besilate nasal product - low dose
干预措施: bepotastine besilate nasal product - low dose (Drug)
Arm 2 - Medium Dose
bepotastine besilate nasal product - medium dose
干预措施: bepotastine besilate nasal product - medium dose (Drug)
Arm 3 - High Dose
bepotastine besilate nasal product - high dose
干预措施: bepotastine besilate nasal product - high dose (Drug)
Arm 4 - Placebo
placebo comparator nasal product
干预措施: placebo comparator nasal product (Drug)
结局指标
主要结局
Mean Change From Baseline (Pre-Dose) in Subject-rated Instantaneous TNSS
时间窗: Baseline, 20 days
Total nasal symptom scores (TNSS) was the summed scores for nasal pruritus \[itching\], rhinorrhea \[runny nose\], nasal congestion, and sneezing. Individual nasal symptoms were 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 maximum score for increased allergic response of 12 units. The minimum possible total score was 0.
次要结局
未报告次要终点