Investigation on Efficacy and Tolerability of Prospan® Hustenzäpfchen for the Symptomatic Treatment of Acute Bronchitis Accompanied by Coughing in Children
试验速览
- 阶段
- 3 期
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Primary outcome measure
研究概览
简要总结
The aims of this study are
- Demonstrating superior efficacy of Prospan® Hustenzäpfchen compared to Placebo in children suffering from acute bronchitis accompanied by coughing
- Characterisation of safety and tolerability of Prospan® Hustenzäpfchen in comparison with placebo.
详细描述
After interim analysis of the first part the clinical study will be continued as follows: Double blind, placebo controlled, randomised, multi-centre study with 2-parallel groups for the treatment of acute bronchitis accompanied by coughing in children aged 0 - 6 years to demonstrate efficacy and safety of Prospan® Hustenzäpfchen.
For assessment of cough intensity and severity a specific symptom score has been developed, which gathers the child's frequency and severity of coughing and of cough productivity as well as the severity of rhonchi (each symptom will be assessed on a four-point Likert scale ranging from 0 to 3; total score range: 0-12 points).
Considering the specificities of the study population and the disease, confirmatory evaluation will be based on the change in the symptom score after the first three consecutive days of treatment as assessed by the investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female children aged 0 to 6 years
- •acute bronchitis existing not longer than three days and accompanied by coughing
- •symptom rating score of ≥ 5 assessed by the investigator
- •symptom 'frequency of coughing' of ≥ 2 assessed by the investigator
- •the patient's legal representatives must give informed consent in accordance with the supposed will of the patient, after having been informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the risk for patients participating in the study -
排除标准
- •hypersensitivity to the active ingredient or to any further constituents of the pharmaceutical preparations
- •patients with severe allergies or multiple drug allergies
- •any other pulmonary disease within the last two weeks
- •chronic pulmonary diseases
- •exacerbation of chronic pulmonary disease
- •suspicion of bacterial pulmonary infection
- •fever above 39°C (rectal measurement) -
研究组 & 干预措施
Prospan Hustenzäpfchen
干预措施: Suppositories containing Ivy leaves dry extract (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Primary outcome measure
时间窗: 7 days
Effect of treatment as primary variable will be assessed by comparing baseline values to those obtained during visit 2. The primary outcome measure for efficacy will be the relative change in the symptom score between visits 1 and 2.
次要结局
- Secondary variables(7 days)