NCT00646321已完成3 期
A 12 Week, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study of SYMBICORT pMDI Administered Once Daily in Children and Adolescents 6 to 15 Years of Age With Asthma - SPROUT
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 540
- 主要终点
- Change in evening PEF
研究概览
简要总结
The purpose of this study is to compare Symbicort with budesonide alone for the treatment of asthma in children aged 6 to 15 years
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
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 6 and maximally 15 years of age
- •Diagnosis of asthma and baseline lung function tests as determined by the protocol
- •Has required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol
排除标准
- •Severe asthma
- •Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
研究组 & 干预措施
1
Experimental
budesonide/formoterol
干预措施: budesonide/formoterol (Symbicort) (Drug)
2
Active Comparator
budesonide
干预措施: budesonide (Drug)
结局指标
主要结局
Change in evening PEF
时间窗: Daily throughout the 12 week treatment period
次要结局
- Lung function, asthma symptoms, use of rescue medication and parent/caregiver/physician reported outcomes(Daily throughout the 12 week treatment period)
- Routine safety assessments described in the protocol(2-4 assessments within 12 week treatment period)
研究者
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