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临床试验/NCT01684540
NCT01684540
已完成
不适用

Non-interventional Study: Application of Ectoin® Rhinitis Nasal Spray in Patients With Acute Rhinosinusitis

Bitop AG6 个研究点 分布在 1 个国家目标入组 66 人2012年2月1日
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.

注册库
clinicaltrials.gov
开始日期
2012年2月1日
结束日期
2012年8月1日
最后更新
3个月前
研究类型
Observational
性别
All

研究者

发起方
Bitop AG
责任方
Sponsor

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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