ACTRN12611001106921已完成3 期
A phase 3, multi-centre, double-blind, randomised, placebo-controlled study testing the efficacy of winter only treatment with omalizumab for the reduction of asthma exacerbations in children aged 6 to 15 years.
niversity of Queensland0 个研究点目标入组 96 人开始时间: 2011年10月24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
- 96
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
- 6 Years 至 15 Years（—）
- 性别
- All
入选标准
- •1. Children of either sex, aged 6 to 15 years, with current asthma;
- •2. Admission to a hospital emergency department in the previous winter season for acute exacerbation of asthma, as defined by the ATS/ERS statement on asthma control and exacerbation;
- •4. Atopic family history;
- •5. Participants who, in the opinion of the site investigator, are able to comply with the protocol for its duration;
- •6. Written informed consent signed and dated by parent/legal guardian according to local regulations.
排除标准
- •1. Hypersensitivity to omalizumab 2. Treatment with omalizumab within 30 days prior to screening 3. Prolonged high dose oral steroids 4. Participation in another randomised controlled trial within the 3 months preceding inclusion in this study 5. A significant medical disease or condition other than asthma that is likely to interfere with the child’s ability to complete the entire protocol.
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