NCT00242775已完成3 期
Efficacy and Safety of Symbicort ®Turbuhaler® 160/4.5 µg/Inhalation, Two Inhalations Twice Daily Plus As-needed Compared With Seretide™ Diskus™ 50/500 µg/Inhalation, One Inhalation Twice Daily Plus Terbutaline Turbuhaler 0.4 mg/Inhalation As-needed - a 6-month, Randomised, Double-blind, Parallel-group, Active Controlled, Multinational Phase IIIB Study in Adult and Adolescent Patients With Persistent Asthma (AHEAD).
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
- 2,100
- 试验地点
- 139
- 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 the efficacy and safety of a variable dose of Symbicort with a high fixed maintenance dose of another asthma medication, Seretide, in the treatment of 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
- •Diagnosed with asthma since at least 6 months prior to first visit
- •Prescribed daily use of glucocorticosteroids for at least 3 months prior to first visit
- •At least one asthma exacerbation more than one but less than twelve months prior to first visit
排除标准
- •Respiratory infection affecting asthma within 30 days before first visit
- •Use of oral, rectal, or parenteral glucocorticosteroids for within 30 days before first visit
- •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
- Patient-reported outcomes regarding disease status (inlc. PEF), collected via questionnaires and diaries
- Healthcare utilization
- Safety (adverse events)
- Number of severe asthma exacerbations
- Mild asthma exacerbations
- FEV1
- - all variables assessed over the 6 months treatment period
研究者
研究点 (139)
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