NCT00662805已完成不适用
A 2-year Observational Study to Evaluate Safety of Seretide 50/500μg Twice Daily Administered by DISKUS, in Patients With COPD
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 762
- 主要终点
- The change in markers of increased cardiovascular risk (e.g proinflammatory and prothrombotic markers, microalbuminuria)
研究概览
简要总结
Primary objective: Evaluation of the safety of Seretide discus administration in subjects with COPD. Treatment duration: 2 years. Study has 3 phases: Screening phase (visit 1), treatment phase (visits 2-5. In the case of AE, there will be another visit (visit 6) as a follow up visit - follow up phase.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject should fulfill criteria for the subscription of SERETIDE as these are mentioned in SPC.
排除标准
- •Hypersensitivity to Salmeterol + Fluticasone or any of its excipients
- •Pregnancy, lactation or scheduled pregnancy during the observational period of the study
- •Serious illness/disease, not adequately controlled, or with a potential to interfere with the patients' participation in the present study, according to the investigator/physician's judgment.
研究组 & 干预措施
Salmeterol/Fluticasone propionate (50/500 μg)
Open label, 6 visits, single arm study
干预措施: Salmeterol/Fluticasone propionate (Drug)
结局指标
主要结局
The change in markers of increased cardiovascular risk (e.g proinflammatory and prothrombotic markers, microalbuminuria)
时间窗: 104 weeks
Evaluate adverse events, vital sign reporting, and concomitant medications
次要结局
- Trough FEV1, FVC and FEV1/ FVC ratio(every 26 weeks)
- Health status as determined using the St George's Respiratory Questionnaire (SGRQ)(every 26 weeks)
- Laboratory assessment including levels of appropriate cardiovascular markers (e.g. CRP, Fibrinogen, PAI-1) and established risk factors, as well as detection of microalbuminuria(every 26 weeks)
研究者
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