A Retrospective Collection of Vital Status and Pulmonary Medication Usage Data for Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Withdrew Prematurely From Either of Two One-Year Trials (205.254, 205.255) of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 441
- 试验地点
- 19
- 主要终点
- Number and status of patients dead or alive at the predicted end of treatment date
研究概览
简要总结
The objectives were to collect information on vital status and pulmonary medication use at the predicted exit date for patients who participated in two one-year trials and withdrew prematurely. The primary objective was to ascertain the vital status (dead or alive) of these patients in the time interval between the patients' withdrawal from the trial and their predicted exit date (i.e: 48 weeks from first intake of randomised treatment + 30 days). The secondary objective was to collect information on classes of pulmonary medication and some other specified pulmonary interventions used by these prematurely discontinued patients at the time of their predicted exit date (i.e 48 weeks from the first intake of randomised treatment + 30 days) or at date of death (if this occurred during the time interval of interest, i.e 48 weeks from the first intake of randomised treatment + 30 days).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who withdrew prematurely from the randomised treatment phase of studies 205.254 and 205.255.
排除标准
- •Not applicable.
研究组 & 干预措施
Premature withdrawal from tiotropium
干预措施: Tiotropium (Drug)
结局指标
主要结局
Number and status of patients dead or alive at the predicted end of treatment date
时间窗: Until 48 weeks after first intake of randomised treatment + 30 days follow-up or date of death
次要结局
- Number and specification of patients on pulmonary medications and other pulmonary interventions(Until 48 weeks after first intake of randomised treatment + 30 days follow-up or date of death)
