NCT00646594已完成3 期
A Two Stage Randomized, Open-Label, Parallel Group, Phase III, Multicenter, 7 Month Study to Assess the Efficacy & Safety of SYMBICORT pMDI Adminstered Either as Fixed or as an Adjustable Regimen Versus a Fixed Regimen of Advair in Subjects 12 Yrs of Age and Older 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
- 1,200
- 主要终点
- Asthma control assessed by asthma exacerbations
研究概览
简要总结
The purpose of this study is to determine whether Symbicort compared with Advair, will be more effective in controlling asthma in adults and adolescents.
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
- 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 within timeframe and doses specified in protocol
排除标准
- •Has required treatment with any non-inhaled corticosteroid within previous 30 days, sensitivity to drugs specified in the protocol, or requires treatment with a 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
budesonide/formoterol
干预措施: budesonide/formoterol (Symbicort) (Drug)
2
Active Comparator
fluticasone/salmeterol
干预措施: fluticasone/salmeterol (Advair) (Drug)
结局指标
主要结局
Asthma control assessed by asthma exacerbations
时间窗: Continuosly throughout the treatment period
次要结局
- Efficacy of Symbicort compared with Advair as assessed by use of rescue medication, asthma symptoms, lung function tests, quality of life reports, patient reported asthma control and patient satisfaction of Symbicort.(Daily and at 1, 3 and 6 months after start of treatmen)
- Use of medical resources and medication for the treatment of asthma.(Throughout the treatment period)
- Investigate safety profile of Symbicort compared to Advair(1, 3 and 6 months after start of treatment and 1 week after end of tretment)
研究者
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