NCT02377895已完成1 期
A Single-Center, Double-Masked, Randomized, Placebo-Controlled, Parallel-Group Allergen BioCube Study Evaluating the Efficacy and Safety of Nasapaque Nasal Solution in a Population of Adult Subjects With Seasonal Allergic Rhinitis
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 73
- 主要终点
- TNSS Total Nasal Symptom Score
研究概览
简要总结
Single-center, double-masked, randomized, placebo-controlled, parallel-group, efficacy and safety study using the Allergen BioCube (ABC).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be 18 years of age and provide written informed consent and sign the HIPAA form
- •Must have history of allergic rhinitis
- •Must have positive response to Allergen BioCube
排除标准
- •Must not have a significant illness such as moderate to severe allergic asthmatic reactions
- •Must not have compromised lung function
- •Must not use any disallowed medications
- •Must not have been in an investigational study in the last 30 days
研究组 & 干预措施
Nasapaque Nasal Solution
Experimental
250 ul in each nostril at Day 1 and Day 8
干预措施: Nasapaque Nasal Solution (Drug)
Placebo Saline Nasal Solution
Active Comparator
250 ul in each nostril at Day 1 and Day 8
干预措施: Placebo Saline Nasal Solution (Drug)
结局指标
主要结局
TNSS Total Nasal Symptom Score
时间窗: Day 1 and Day 8
次要结局
- Nasal Inspiratory Flow(Day 1 and Day 8)
- Nasal Inflammation Score(Day 1 and Day 8)
研究者
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