A Dose-Ranging Study to Evaluate the Safety and Efficacy of Bepotastine Besilate Nasal Sprays in the Treatment of Seasonal Allergic Rhinitis (SAR) in Subjects With a Demonstrated History of Mountain Cedar Pollen Allergic Sensitivity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 617
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline (Pre-Dose) Twice Daily Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS)
研究概览
简要总结
This study will examine dose ranging characteristics of bepotastine besilate nasal spray compared to placebo nasal spray in 600 male or female subjects 12 years of age and older with active seasonal allergic rhinitis (SAR) and a demonstrated history of allergic sensitivity to Mountain Cedar pollen for at least 2 years prior to the study.
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
- •The subject is a male or female 12 years of age or older.
- •Have a documented history of SAR resulting from exposure to Mountain Cedar pollen for a minimum of 2 years immediately preceding Screening Visit
- •Have demonstrated sensitivity to Mountain Cedar pollen through a standard skin prick test.
- •Have a minimum rTNSS of at least 6 units for the morning (AM) assessment on the day of Visit 2 and Visit
- •Have a minimum average rTNSS score of at least 6 units for 3 of the worst 4 days prior to Visit 3 plus the AM assessment on the day of Visit
- •Have a minimum stuffy nose score of at least 2 units on the day of Visit
- •Have a minimum average stuffy nose score of at least 2 units for 3 of the worst 4 days prior to Visit 3 plus the AM assessment on the day of Visit
- •Have at least one score ≥ 2 units at Visit 3 of any of the RQLQ(S) questions #4-#6 regarding sleep.
排除标准
- •Have a nasal condition which, in the opinion of the Investigator, interferes with successful nasal drug administration or absorption (in either nostril) within the last 60 days prior to Screening Visit
- •Have asthma requiring medication other than intermittent use of an inhaled short-acting β-agonist.
- •Is participating or have participated in any investigational drug or device study within 30 days preceding Visit
- •Have had nasal or sinus surgery within 12 weeks of Visit
- •Have a known sensitivity to bepotastine besilate or any excipient component of the investigational product (IP).
- •For female subjects 12 years of age or older (other than those who have been menopausal for at least 24 months or those who are surgically sterile), are pregnant, planning to become pregnant, or nursing/lactating, or refuses to abide by the contraception stipulations in the inclusion criteria.
研究组 & 干预措施
Bepotastine besilate Concentration 1
Bepotastine besilate nasal spray, BID for 14 days.
干预措施: Bepotastine besilate (Drug)
Placebo
Placebo nasal spray BID for 14 days
干预措施: Placebo (Drug)
Bepotastine besilate Concentration 2
Bepotastine besilate nasal spray, BID for 14 days.
干预措施: Bepotastine besilate (Drug)
Bepotastine besilate Concentration 3
Bepotastine besilate nasal spray, BID for 14 days.
干预措施: Bepotastine besilate (Drug)
Bepotastine besilate Concentration 4
Bepotastine besilate nasal spray, BID for 14 days.
干预措施: Bepotastine besilate (Drug)
结局指标
主要结局
Mean Change From Baseline (Pre-Dose) Twice Daily Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS)
时间窗: 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
- Mean Change From Baseline (Pre-Dose) in Morning Averaged Subject-rated Reflective (TNSS)(14 Days)
- Mean Change From Baseline (Pre-Dose) in Evening Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS)(14 Days)