Non Interventional Study of Ectoin Allergy Nasal Spray Compared to Beclomethasone Nasal Spray
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bitop AG
- 入组人数
- 50
- 主要终点
- Change in Total Nasal Symptom Score
研究概览
简要总结
This is a comparative, open label, parallel group, non interventional study to further demonstrate the effectiveness and tolerability of Ectoin® Allergy Nasal Spray. In addition the effectiveness and safety shall be compared to a Beclomethasone nasal spray. The patient applies Ectoin® Rhinitis Nasal Spray or Beclomethasone nasal spray according to the instructions for use. The observation takes place over a period of 14 days. Response to treatment is recorded at day 7 and day 14 by the physician and in daily by the patient in a dairy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed allergic rhinitis during the observational period
排除标准
- •Contra indications according to the label
研究组 & 干预措施
Ectoin Group
Ectoin Allergy Nasal Spray (Medical Device, drug-like)
干预措施: Medical Device, drug-like (Other)
Beclomethasone Group
Beclomethasone nasal spray
干预措施: Beclomethasone (Drug)
结局指标
主要结局
Change in Total Nasal Symptom Score
时间窗: Time Frame: day 1, day 7, day 14
次要结局
- Change in quality of life assessed by Rhinitis Quality of Life Questionnaire(Day1 and Day 14)
- Change in palatal itching score(Day 1, 7 and 14)
- Efficacy and tolerability assessment by the patients and by the investigator(day 7 and 14)