NCT00651547已完成3 期
A 12 Week Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial of Symbicort TM (40/4.5 Mcg) Versus Its Mono-Products (Budesonide and Formoterol) in Asthmatic Children Aged Six to Eleven Years - SEEDLING 40/4.5
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
- 405
- 主要终点
- Morning PEF
研究概览
简要总结
The purpose of this study is to compare Symbicort with budesonide alone and formoterol alone in the treatment of asthma in children aged 6 to 11 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Baseline lung function tests results as determined by the protocol
- •Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol
排除标准
- •Has required treatment with non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
- •Has been hospitalised or required emergency treatment for asthma-related condition within previous 6 months
- •Has had cancer within previous 5 years or has a significant disease, as judged by investigator, that may put the patient at risk in this study
研究组 & 干预措施
1
Experimental
干预措施: budesonide/formoterol (Drug)
2
Active Comparator
干预措施: budesonide (Drug)
3
Active Comparator
干预措施: formoterol (Drug)
结局指标
主要结局
Morning PEF
时间窗: Daily
次要结局
- Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments(Throughout the treatment period)
研究者
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