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临床试验/NCT02172560
NCT02172560已完成不适用

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

Boehringer Ingelheim19 个研究点 分布在 3 个国家目标入组 441 人开始时间: 2007年3月最近更新:
适应症
干预措施
相关药物

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

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (19)

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