NCT00641446已完成4 期
Rates of Seroconversion Following Varicella Vaccination of Asthmatic Children Between the Ages of One and Eight Years Treated With Pulmicort Respules® Versus Non-Steroidal Conventional Asthma Therapy
适应症
干预措施
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
- 250
- 主要终点
- Seroconversion level
研究概览
简要总结
A study to determine whether treatment with Pulmicort in children has any effect on the varicella vaccine
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Months 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between the age of 10 months and 8 years,
- •have asthma or shown recent signs suggesting asthma,
- •have a parent or guardian willing to comply with study requirements
排除标准
- •Varicella zoster immune globulin (VZIG) within 5 months prior to immunization,
- •Previous varicella immunization,
- •an immunization or allergy immunotherapy 4 weeks prior to immunization,
- •Severe asthma,
- •have another persistent lung disease,
- •have a planned hospitalization for the duration of study
研究组 & 干预措施
1
Experimental
Pulmicort
干预措施: budesonide (Drug)
2
Active Comparator
Varivax
干预措施: varicella zoster virus (Drug)
结局指标
主要结局
Seroconversion level
时间窗: Week 6
次要结局
未报告次要终点
研究者
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