NCT00480649已完成4 期
SUccessful Control and Clinical Effectiveness of SERETIDE Study in aSthma, a Randomised Controlled Study to Investigate the Clinical Effectiveness and Health Outcome of SERETIDE in Patients With Moderate and Severe Persistent Asthma in Korea
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 424
- 试验地点
- 1
- 主要终点
- The primary efficacy endpoint for this trial is mean morning PEFR LOCF at 52 weeks as collected in diary cards over the last 2 weeks preceding the 52 weeks visit.
研究概览
简要总结
The primary study objective is to demonstrate the clinical effectiveness of SERETIDE therapy compared to the current care in management of moderate to severe persistent asthma patients in Korea.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sal/FP 50/250mcg
Active Comparator
SERETIDE 50/250
干预措施: Salmeterol/ fluticasone propionate (Drug)
Sal/FP 50/500mcg
Active Comparator
SERETIDE 50/500
干预措施: Salmeterol/ fluticasone propionate (Drug)
结局指标
主要结局
The primary efficacy endpoint for this trial is mean morning PEFR LOCF at 52 weeks as collected in diary cards over the last 2 weeks preceding the 52 weeks visit.
时间窗: 52 weeks after randomization
次要结局
- Secondary measures of efficacy consist of clinical efficacy and health outcome measurements.(52 weeks after randomization)
研究者
研究点 (1)
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