NCT02160912已完成不适用
Non Interventional Study Regarding the Application of Ectoin Mund- & Rachenspray in Patients With Acute Laryngitis and/or Acute Pharyngitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bitop AG
- 入组人数
- 95
- 试验地点
- 8
- 主要终点
- Change in Pharyngitis symptom score evaluated by the physician
研究概览
简要总结
In this observational study insights regarding the tolerability and influence on the quality of life of the topical treatment Ectoin Mund- and Rachenspray compared to Emser Pastillen in patients with acute Pharyngitis/ Laryngitis under real life conditions shall be gained.
Patients are treated with Ectoin Mund- & Rachenspray 1% or Emser Pastillen according to the demands of the physician and the instructions for use.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute Laryngitis and/or Pharyngitis which are already treated with Ectoin Mund- & Rachenspray 1% or Emser Pastillen
排除标准
- •contraindications according to instructions for use
结局指标
主要结局
Change in Pharyngitis symptom score evaluated by the physician
时间窗: Visit 1, Visit 2 (after 3 days), Visite 3 (after 7 days)
Assessment of the symptoms of pharyngitis on a 4 point scale (none, mild, moderate strong): * swollen palatine tonsils * swollen lymph nodes in the throat * fever * cough
次要结局
- Change in patient's general condition evaluated by the physician(Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days))
- Change in Evaluation of the hoarseness(Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days))
- Change in Dysphagia(Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days))
- Change in efficacy evaluation by the physician(Visit 1, Visit 2 (after 3 days), Visit 3 (after 1 week))
- Change in efficacy evaluation by the patient(Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days))
- Change in Evaluation of the tolerability by the physician(Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)))
- Change in number and type of adverse events(Visit 2 (after 3 days) Visit 3 (after 7 days))
- Change in Evaluation of the tolerability by the patient(Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)))
研究者
研究点 (8)
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