Oral Bacterial Lysate to Prevent Persistent Wheeze in Infants After Severe Bronchiolitis; a Randomised Placebo-controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 894
- 试验地点
- 1
- 主要终点
- Occurrence of parent-reported, healthcare professional-confirmed wheeze between 19 and 24 months after initiation of IMP or placebo.
研究概览
简要总结
The goal of this clinical trial is to learn about the effects of using bacterial lysate in bronchiolitis. The main question it aims to answer are:
Does the use of bacterial lysate after bronchiolitis reduce the likelihood of preschool wheeze
Participants will take either the active medicine or a placebo for 24 months.
详细描述
To establish whether there is superiority of oral BV (broncho vaxom) over placebo in the prevention of parent-reported, healthcare professional-confirmed, persistent wheeze between 19 and 24 months post initiation of IMP/placebo, after a hospital admission for severe bronchiolitis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Weeks 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intervention
Bacterial Lysate - Broncho-Vaxom (OM-85) 3.5mg granules once daily for 10 days per month for 24 months
干预措施: Bacterial Lysate (Biological)
Placebo
Placebo - 3.5mg granules once daily for 10 days per month for 24 months
干预措施: Placebo (Drug)
结局指标
主要结局
Occurrence of parent-reported, healthcare professional-confirmed wheeze between 19 and 24 months after initiation of IMP or placebo.
时间窗: 24 months
Occurrence of parent-reported, healthcare professional-confirmed wheeze between 19 and 24 months after initiation of IMP or placebo.
次要结局
- Use of medication(24 months)
- Asthma or Wheeze Diagnosis(24 months)
- Unscheduled Medical attendances(24 months)
- Number of courses of oral steroids(24 months)
- Montelukast use(24 months)
- Number of courses of antibiotics(24 months)
- Eczema diagnosis(24 months)
- Safety and Tolerability(24 months)