NCT00646529已完成3 期
A Six Month, Randomized, Open-Label, Safety Study of Symbicort (160/4.5mcg) Compared to Pulmicort Turbuhaler in Asthmatic Children Aged Six to Eleven Years - SAPLING
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
- 175
- 主要终点
- Long term safety profile of Symbicort compared to Pulmicort as determined by safety assessments detailed in the protocol
研究概览
简要总结
The purpose of this study is to assess the safety of Symbicort compared to Pulmicort in asthmatic 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
- None
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
- •At least 6 and maximally 11 years of age
- •Diagnosis of asthma
- •Baseline lung function tests as determined by protocol and required and received daily treatment with inhaled corticosteroids for at least 4 weeks prior to study start
排除标准
- •Has required treatment with any non-inhaled corticosteroids within the previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
- •Has had cancer in the previous 5 years or has a significant disease that may put the patient at risk in this study
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 (Pulmicort) (Drug)
结局指标
主要结局
Long term safety profile of Symbicort compared to Pulmicort as determined by safety assessments detailed in the protocol
时间窗: 4 assessments within 26 week treatment period
次要结局
- Compare health economic outcomes and quality of life between patients treated with Symbicort and Pulmicort(4 assessments within 26 week treatment period)
研究者
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