NCT01503957已完成3 期
Double-blind, Randomized, Placebo-controlled, Crossover Clinical Investigation to Evaluate Safety and Efficacy of Nasya in Reducing Symptoms of Allergic Rhinitis When Applied Before Allergen Challenge
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Difference in Total Nasal Symptom Score
研究概览
简要总结
The purpose of this study is to evaluate safety and efficacy of Nasya in reducing symptoms of persistent allergic rhinitis when applied before allergen challenge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of persistent allergic rhinitis due to house dust mite allergy ≥ 2 years
- •Written informed consent
排除标准
- •Clinically significant disease that could interfere with the evaluation of study medication
- •Participation in other studies within the last 4 weeks / during the study
研究组 & 干预措施
Saline solution
Placebo Comparator
Nasal spray
干预措施: Saline solution (Device)
Nasya
Experimental
Thixotropic nasal spray suspension
干预措施: Nasya (Device)
结局指标
主要结局
Difference in Total Nasal Symptom Score
时间窗: 75 minutes
次要结局
- Difference in Total Nasal Symptom Score(Up to 240 minutes)
- Difference in Total Ocular Symptom Score(Up to 240 minutes)
研究者
研究点 (1)
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