NCT00699699已完成不适用
Assessment of Physical Activity (PF10 Sub Domain of SF-36 Activity Score) and Tolerability in COPD Patients During Treatment With Spiriva® Respimat®
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,280
- 试验地点
- 9
- 主要终点
- Therapeutic Success as Change From Baseline in Physical Functioning After 6 Weeks
研究概览
简要总结
This observational non-interventional study is designed to demonstrate the improvement of physical function in COPD patients on treatment with Spiriva Respimat and allows adverse events to be recorded and evaluated.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •COPD patients who require treatment with longacting anticholinergic
排除标准
- •Patients cannot be recruited if any of the general or specific contraindications listed in the Patient information leaflet or the Summary of Product Characteristics applies. Spiriva® Respimat® is contraindicated in patients with hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to any of the excipients.
结局指标
主要结局
Therapeutic Success as Change From Baseline in Physical Functioning After 6 Weeks
时间窗: Baseline and after 6 weeks of treatment
Main efficacy measure was therapeutic success rate defined as an improvement from baseline after 6 weeks by at least 10 score points in the PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition)
次要结局
- Change From Baseline in the PF-10 Score After 6 Weeks(Baseline and after 6 weeks of treatment)
- Change From Baseline After 6 Weeks in Physician's Global Evaluation (PGE) Form Safety(Baseline and after 6 weeks of treatment)
- Patients' Satisfaction After 6 Weeks of Treatment(6 weeks)
研究者
研究点 (9)
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