NCT00651768已完成3 期
A 52 wk Randomized, Doubleblind, Single Dummy, Parallel Group Multicenter Phase 3 Study Comparing the Long Term Safety of Symbicort pMDI 4x160/4.5mcg Bid to SymbicortpMDI 2x160/4.5mcg Bid & Budesonide HFA pMDI 4x160mcg Bid in Adult and Adolescent Subjects With Asthma
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
- 570
- 主要终点
- Asthma exacerbations, ECG and Holter monitors, lung function, adverse events, requirement of other asthma therapies and other routine safety assessments.
研究概览
简要总结
The purpose of this study is to compare the long term safety of Symbicort with budesonide alone, in adolescents and adults with asthma.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of asthma and baseline lung function tests, symptoms and medication use 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 30 days, has sensitivity to drugs specified in the protocol or requires treatment with a beta-blocker.
- •Has had cancer within previous 5 years or has a condition 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
Sham Comparator
干预措施: Symbicort pMDI + budesonide HFA pMDI (Drug)
结局指标
主要结局
Asthma exacerbations, ECG and Holter monitors, lung function, adverse events, requirement of other asthma therapies and other routine safety assessments.
时间窗: 7 assessments within 12 month treatment period
次要结局
- To measure changes in lung function tests, patient reported outcomes and usage of medical resource(7 assessments within 12 month treatment period)
- Blood levels of budesonide and formoterol(10 blood samples taken at 1 visit in a sub-set of patients)
研究者
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