NCT00234390已完成4 期
Prevention of Asthma in Infants/Young Children - PAC
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- symptom free days
研究概览
简要总结
The purpose of this study is to investigate the ability of budesonide, given during episodes of troublesome lung symptoms to reduce further symptoms in infants and young children at risk of developing asthma
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
- Double
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of asthmatic mothers form the COPSAC birth cohort study
排除标准
- •Children born more than 4 weeks preterm
- •children with other systemic illness that atopy/allergy
- •Children requiring mechanical ventilation at any time since birth.
结局指标
主要结局
symptom free days
days with no use of bronchodilator
days with no use of bronchodilator and no symptoms
number of treated episodes
number of treatment with add-on medication
次要结局
- asthma status
- time to start of algorithm treatment
- the total steroid dose
- First treatment episode:
- number of symptom days
- number of days with use of bronchodilator
- number of patients who needed add-on medication
- BMD
- height
- serious adverse events
研究者
研究点 (1)
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