NCT02045550Unknown2 期
Tolerance and Effect of a Prophylactical Treatment With a Cough Medicine Con-taining Ivy Leaves Dry Extract in Children With Recurrent Wheezy Bronchitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- the time to event (next bronchitis episode) rate during and after treatment period
研究概览
简要总结
To evaluate the effect of a prophylactical therapy with a cough medicine containing ivy leaves dry extract on the frequency of recurrent wheezy bronchitis in toddlers, on the duration of the bronchitis episodes, on the severity and the additional drug demand. A prolonged asymptomatic episode between each wheezy bronchitis due to the therapy is assumed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Year 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medical diagnosis of ≥3 episodes of wheezy bronchitis within the pre-vious 12 months
- •Children aged from 1 to 3 years (girls and boys)
- •Signed Informed Consent of the legal guardians to participate in the trial after written and verbal briefing by the Investigator
- •No allergic sensitization
- •Allowance to contact the familys pediatrician for medical history of wheezy bronchitis episodes
排除标准
- •Anamnestically known intolerance/allergy to one of the drugs applied or to their ingredients or to drugs of similar chemical structure
- •Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial
- •Evidence suggesting that the patient or their legal representative is not likely to follow the trial protocol (e.g. lacking compliance)
- •Inability to document the symptoms in a symptom log book or ques-tionnaire; inability to take the trial medication properly
- •Any regular therapy except Vitamin D or Fluoride
- •Chronic illnesses of different aetiology
- •Premature birth or diagnosis of bronchopulmonary dysplasia
- •Gastro-oesophageal reflux
- •Hereditary fructose intolerance
研究组 & 干预措施
Prospan Syrup
Active Comparator
Prospan Syrup 2.5 ml twice daily for 4 weeks
干预措施: Prospan Syrup (Drug)
结局指标
主要结局
the time to event (next bronchitis episode) rate during and after treatment period
时间窗: three months
次要结局
- days and percentage of days without bronchitis during and after treatment period(3 months)
- days and percentage of days without bronchitis during treatment period(three months)
研究者
研究点 (1)
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