NCT00242411已完成4 期
A Comparison of the Efficacy of Symbicort® Single Inhaler Therapy (Symbicort Turbuhaler® 160/4.5 mg 1 Inhalation b.i.d. Plus As-needed) and Conventional Best Standard Treatment for the Treatment of Persistent Asthma in Adolescents and Adults. A Randomized, Open, Parallel-group, Multicentre 26-weeks Study
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,900
- 试验地点
- 179
- 主要终点
- Time to first severe asthma exacerbation
研究概览
简要总结
The purpose of the study is to compare the efficacy of a flexible dose of Symbicort (budesonide/formoterol) with conventional stepwise best standard treatment in patients with persistent 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
- 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 >= 3 months
- •Prescribed daily use of glucocorticosteroids for at least 3 months prior to Visit 1
排除标准
- •Smoking history > 10 pack-years
- •Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to inclusion
- •Any significant disease or disorder that may jeopardize the safety of the patient.
- •Additional inclusion and exclusion criteria will be evaluated by the investigator.
结局指标
主要结局
Time to first severe asthma exacerbation
次要结局
- Asthma Control Questionnaire
- Number of asthma exacerbations
- Mean use of as-needed medication
- Prescribed asthma medication
- Safety: serious adverse events and discontinuations due to adverse events
- All variables assessed over the 6 month treatment period
研究者
研究点 (179)
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