NCT00252863已完成3 期
A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbuhaler 160/4.5 µg, 1 Inhalation b.i.d. Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adults - a 26-Week, Randomised, Open-Label, Parallel-Group, Multicentre Study
适应症
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
- 1,600
- 试验地点
- 157
- 主要终点
- Time to first severe asthma exacerbation
研究概览
简要总结
The purpose of this study is to determine whether Symbicort dosed according to the Symbicort Maintenance and Reliever Therapy (SMART) concept is superior to standard asthma treatment according to the local German treatment guidelines.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with asthma, either well-controlled on a regular therapy with a combination of long-acting beta-agonists and inhaled corticosteroids or symptomatic on therapy with inhaled corticosteroids alone.
排除标准
- •Any other significant lung disease other than asthma
- •Any disease that might put patients at risk if they participate in the study
结局指标
主要结局
Time to first severe asthma exacerbation
次要结局
- Number of severe asthma exacerbations
- Health care contacts
- Asthma medication
- Mean use of as-needed medication
- Change in forced expiratory volume in 1 second (FEV1) from the end of run-in to the end of the study period
- Prescribed asthma medication during the treatment period
- Asthma Control Questionnaire (ACQ)
- Patient's satisfaction with the treatment question
- Serious adverse events (SAEs)
- Discontinuations due to adverse events (AEs)
- Time lost from paid and unpaid work
研究者
研究点 (157)
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