Non-interventional Multicentric Study on Treatment of Respiratory Tract Infection and/or Acute Bronchitis With Ectoin Inhalation Solution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bitop AG
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Change in Bronchitis Severity Score on physician´s evaluation (5 point IMOS scale)
研究概览
简要总结
This observational, non-interventional multicentric study compares the inhalation therapy on patients suffering on respiratory tract infections and/or acute bronchitis between Ectoin inhalation solution and Pari NaCl (0.9%) inhalation solution
详细描述
The assessment focuses on the bronchitis Severity Score (BSS) for standardized use in clinical studies with the outcome criteria of cough, sputum production, rales/rhonchi, chest pain during coughing and dysnoea
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
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •according to instruction for use
排除标准
- •according to instruction for use
结局指标
主要结局
Change in Bronchitis Severity Score on physician´s evaluation (5 point IMOS scale)
时间窗: day 7
Assessment of bronchits severity score on a 5 point IMOS scale (complete recovery, major improvement, slight to moderate improvement, no change, deterioration) of symptoms: Cough, sputum production, rales/rhonchi, chest pain during coughing, dyspnoea
次要结局
- Change in bronchitis symptoms evaluated on patients´ diaries (5 point scale)(day 14)
- patients´ evaluation of tolerability (4 point scale)(day7)
- physicians´ evaluation of tolerability (4 point scale)(day 7)
- patients´ evaluation of efficacy (five point IMOS scale)(day 7)
- physicians´ evaluation of efficacy (five point IMOS scale)(day 7)
- Change in number and type of adverse events(day 7)