Randomized Double-blind Placebo-controlled, Parallel, Multi Centre Clinical Trial of Sublingual Bacterial Vaccine in Children With Recurrent Bronchospasm (Wheezing Attacks) for the Evaluation of Efficacy, Security and Clinical Impact.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Number of Recurrent Bronchospasm (Wheezing Attacks)
研究概览
简要总结
The study will be conducted in two hospitals of the same geographic area. It will be included children <3-years-old with recurrent wheezing attacks, confirmed by the review of the medical records, in the previous 12 months or a shorter time for those younger than one year.
详细描述
This randomized, double-blind, placebo-controlled, parallel-group study will included 120 children <3 years old with ≥3 episodes of wheezing during the previous year. They will receive active treatment or placebo for six months. The main outcome will be the number of wheezing attacks during one year. Other outcomes were duration and severity of wheezing attacks , symptom and medication scores, and use of health resources.
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
- 12 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects whose parents /legal representative have given written informed consent.
- •Both gender
- •Subject up to 36 months of age.
- •Subjects with recurrent bronchospasms (wheezing attacks); 3 or more exacerbations in the last 12 months
排除标准
- •Subjects whose parents/legal representative have not given written informed consent.
- •Subjects out of aged range
- •Subjects with malignancies or chemotherapy treatment
- •Subjects included in another clinical trial in the last 12 months.
- •Subject in immunosuppressive or immunostimulatory treatment
- •Subjects who have received iv gamma globulin in the past 12 months.
- •Subjects diagnosed with candidiasis or fungal recurrent infections.
- •Subjects diagnosed with malabsorption syndrome
- •Subjects with clinical allergy to common aeroallergens in the geographical area.
- •Subjects with hepatitis virus infections, HIV and tuberculosis
结局指标
主要结局
Number of Recurrent Bronchospasm (Wheezing Attacks)
时间窗: 12 months
Assessment of reduction of bronchospasm (wheezing attacks) episodes at 12 months. The number of bronchospasm (wheezing attacks) episodes, in active and placebo group will be compared
次要结局
- Duration (Days) of Wheezing Attacks (WA)(12 months)
- Number of Days With Wheezing Attacks During the Study(12 months)
- Symptom Score During Wheezing Attacks(12 months)
- Time Until Appearance of First WA(12 months)
- Number of Patients With Recurrent WA During the Study(12 months)
- Medication Score During WA(12 months)
- Overall Symptom Score(12 months)
- Overall Medication Score(12 months)