ACTRN12612000518864已完成3 期
A phase 3, single-centre, double-blind, randomised, placebo-controlled study testing the primary prevention of persistent asthma in high risk children by protection against acute respiratory infections during early childhood using OM-85.
Child Health Research Centre, University of Queensland0 个研究点目标入组 60 人开始时间: 2012年5月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 3 Months 至 9 Months（—）
- 性别
- All
入选标准
- •1. Children of either sex, aged 3-9 months old whose biological mother, father, or sibling has a history of asthma and/or atopy (defined as SPT reactivity to one or more allergen, food allergy, atopic dermatitis or allergic rhinitis) 2. Participants who, in the opinion of the investigator, are able to comply with the protocol for its duration 3. Written informed consent signed and dated by parent/legal guardian according to local regulations
排除标准
- •1.Children born less than 36 weeks gestation
- •2.Children who have been diagnosed with asthma
- •3.Children who have chronic pulmonary disease or other chronic disease (other than atopic dermatitis, food allergy, or chronic rhinitis) requiring therapy
- •4.Participation in another randomized controlled trial within the 3 months preceding inclusion in this study
- •5.Children who has previously received OM-85 or other immunostimulant or immunosuppressive drugs including cyclosporine
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