Non Interventional, Open Label Trial of Ectoine Containing Nasal Spray in Comparison With Cromoglycic Acid Containing Nasal Spray in Patients With Allergic Rhinitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bitop AG
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in combined 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 Cromoglycid acid containing nasal spray. The patient applies Ectoin Allergy Nasal Spray or Cromoglycid acid containing 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 by the patient in a dairy at defined time intervalls.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male individuals ≥ 18 years
- •Patients with proven Allergic Rhinitis which are treated with Ectoin Nasal Spray or -Cromoglycic acid nasal Spray 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
干预措施: Medica device, drug-like (Other)
Cromolyn group
Cromolyn sodium
结局指标
主要结局
Change in combined nasal symptom Score
时间窗: Time Frame: day 1, day 7, day 14
The change in the sum of the three different parameters nasal congestion, rhinorrhea and nasal errhine were investigated as combined score.
次要结局
- Patient's and physician's judgment of efficacy(Day 7 and 14)
- Eye itching score,(Day 1, 7, 14)
- Epiphora score(Day1, Day 7 and Day 14)
- Conjunctivitis score,(Day 1, Day 7 Day 10)
- Palatal itching score(Day 1, Day 7, Day 14)
- Nasal muscle hyperplasia score(Day 1, Day 7 and Day 14)