NCT00641472已完成4 期
An Evaluation of the Effectiveness of Pulmicort Respules (Budesonide Inhalation Suspension) Versus SINGULAIR (Montelukast Sodium) in Children 2-8 Years Old With Asthma Requiring Controller 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
- 380
- 主要终点
- Time to first asthma medication as either step-up PULMICORT RESPULES or oral steroids
研究概览
简要总结
A one year study comparing the safety and effectiveness of Pulmicort (0.5mg strength given once a day in the evening) with either 4 or 5mg strength SINGULAR (given once a day in the evening) in children with asthma aged 2 to 8. If allocated to SINGULAR treatment, children aged between 2 and 5 will receive 4mg strength SINGULAR and those aged between 6 and 8 will receive 5mg strength SINGULAR.
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
- None
入排标准
- 年龄范围
- 2 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 2 to 8 at study entry
- •At least 3 episodes of wheezing in the previous year that lasted more than 24 hours and affected sleep or symptoms of mild persistent asthma
- •use of b-2 agonist treatment on at least 3 of 7 consecutive days or run in
排除标准
- •Severe or unstable asthma
- •any significant finding at a physical exam
- •an exacerbation of asthma in the 30 days before entering the study that might affect study results in judgement of the study doctor
研究组 & 干预措施
1
Experimental
Budesonide inhalation suspension
干预措施: Budesonide inhalation suspension (Drug)
2
Active Comparator
Montelukast sodium
干预措施: Montelukast Sodium (Drug)
结局指标
主要结局
Time to first asthma medication as either step-up PULMICORT RESPULES or oral steroids
时间窗: Each clinic visit
次要结局
- Incidence and Severity of Adverse Events(Each clinic visit)
- Time to 1st additional asthma medication measured at 12 weeks and 26 weeks(Each clinic visit)
- Time to 1st acute severe exacerbation (as measured by the need for oral steroids), measured at 12 weeks, 26 weeks, and 52 weeks(Each clinic visit)
研究者
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