NCT00646516已完成3 期
A Rand, Doubleblind, Activecontrolled, Parallel-grp,Singledummy, Multicenter,12 wk Study to Assess the Effic.&Safety of Symbicort pMDI 2x160/4.5mcg QD Compared to Symb. pMDI 2x80/4.5mcg QD, Symb. pMDI 2x80/4.5mcg Bid and to Budesonide pMDI 2x160 Mcg QD in Asthmatic Sub's12yrs and Over
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
- 615
- 主要终点
- Change from start of treatment in evening pre-dose FEV1
研究概览
简要总结
The purpose of this study is to determine whether treatment with Symbicort for 12 weeks will improve lung function and symptoms of adults and adolescents 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
- Double
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
- •Baseline lung function tests as determined by protocol.
- •Required and received treatment with inhaled corticosteroids and/or lung treatments specified in the protocol within timeframe and doses specified in protocol.
排除标准
- •Severe asthma
- •Has required treatment with any non-inhaled corticosteroid within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
- •Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator
研究组 & 干预措施
1
Experimental
干预措施: budesonide/formoterol (Symbicort) (Drug)
结局指标
主要结局
Change from start of treatment in evening pre-dose FEV1
时间窗: 2, 6 and 12 weeks after starting treatment
次要结局
- Change from before treatment in lung function, symptoms, use of rescue medication and patient-physician reported outcomes(Daily)
- Investigate safety profile of Symbicort and budesonide(Before and 2, 4, 12 weeks after start of treatment and 1 week after end of treatment)
研究者
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