NCT00238784已完成3 期
A Comparison of Symbicort® Single Inhaler Therapy (Symbicort® 200 Turbuhaler® 1 Inhalation b.i.d. Plus as Needed) & Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents & Adults-a 26-Week, Randomised, Open-Label, Parallel Group, Multicentre Study
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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
- 1,300
- 试验地点
- 3
- 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 compare Symbicort Single Inhaler treatment with the Best Conventional Practice 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 my 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
- Patient reported Outcomes
- All variables assessed over the 6 months treatment period
- Number of asthma exacerbations
- Health care resource use
- Mean use of as-needed medication
- Safety: Adverse Events, Serious Adverse Events and discontinuations due to Adverse Events
- Induced sputum will be sampled from a subset of patients
- Prescribed asthma medication
研究者
研究点 (3)
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进行中（未招募）
不适用
A comparison of Symbicort Single inhaler Therapy (Symbicort Turbuhaler 160/4.5 mg, 1 inhalation b.i.d. plus as needed) and conventional best practice for the treatment of persistent asthma in adolescents and adults - a 26-week, randomised, open-label, parallel-group, multicentre study - STYLEThis is a Phase IIIB trial to be conducted in patients with persistent asthmaMedDRA version: 7.0Level: LLTClassification code 10003553EUCTR2005-000532-25-LTAstraZeneca AB1,000