NCT01684540
已完成
不适用
Non-interventional Study: Application of Ectoin® Rhinitis Nasal Spray in Patients With Acute Rhinosinusitis
适应症Sinusitis
相关药物Sinupret forte
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Sinusitis
- 发起方
- Bitop AG
- 入组人数
- 66
- 试验地点
- 6
- 主要终点
- Changes in the symptoms of acute Rhinosinusitis assessed by the EPOS- Sinusitis-Symptom-Score
- 状态
- 已完成
- 最后更新
- 3个月前
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® Rhinitis Nasal Spray. In addition the effectiveness and safety shall be compared to a Sinupret forte. The patient applies Ectoin® Rhinitis Nasal Spray or takes Sinupret forte 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.
研究者
入排标准
入选标准
- •Female or male individuals ≥ 18 years
- •Patients with acute Rhinosinusitis which are treated with Ectoin® Rhinitis Nasal Spray or Sinupret forte during the observational period
排除标准
- •Contra indications according to the label
结局指标
主要结局
Changes in the symptoms of acute Rhinosinusitis assessed by the EPOS- Sinusitis-Symptom-Score
时间窗: day 1, day 7, day 14
次要结局
- Quality of Life questionnaire (Rhino QoL)(day 1, day 7, day 14)
- Rhinoscopy(day 1, day 7, day 14)
- Patient's and physician's judgment of efficacy(day 7, day 14)
研究点 (6)
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