NCT00269126已完成3 期
See Detailed Description
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change from baseline in pre-dose FEV1 at 4 weeks after starting medication of GW815SF 50/250µg
研究概览
简要总结
This study compares the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease). This study will last up to 18 weeks, and subjects will visit the clinic 5 times. Subjects will be given breathing tests, and will record their breathing symptoms daily on diary cards.
详细描述
Clinical Evaluation of GW815SF for Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema) "Assessment of the Effect of Addition of Fluticasone Dipropionate to Salmeterol Xinafoate 50µg after Switching under Double-blinded conditions to GW815SF 50/250µg in Chronic Obstructive Pulmonary Disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of COPD.
排除标准
- •Diagnosis of asthma or an uncontrolled medical condition or respiratory disorder other than COPD.
- •Other inclusion and exclusion criteria will be evaluated at the first study visit.
结局指标
主要结局
Change from baseline in pre-dose FEV1 at 4 weeks after starting medication of GW815SF 50/250µg
次要结局
- Change in morning PEF
- Changes in pre-dose FVC, V50, V25
- Use of rescue medication
- Changes in symptom scores
研究者
研究点 (2)
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