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临床试验/NCT02172482
NCT02172482已完成不适用

Tolerability and Efficacy of Spiriva® 18 Micrograms in Patients With COPD in Daily Practice

Boehringer Ingelheim0 个研究点目标入组 63,127 人开始时间: 2002年6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
63,127
主要终点
Change from baseline in breathlessness when walking/climbing stairs

研究概览

简要总结

As part of the post-marketing surveillance, information is to be gathered regarding the tolerance and efficacy of Spiriva® 18 micrograms in patients with COPD under conditions of daily practice

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women aged at least 40 years presenting with the symptoms of COPD

排除标准

  • Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information

研究组 & 干预措施

Symptoms of COPD

Patients with symptoms of COPD receiving Tiotropium bromide 18 micrograms

干预措施: Tiotropium bromide (Drug)

结局指标

主要结局

Change from baseline in breathlessness when walking/climbing stairs

时间窗: Baseline, after 4 weeks

Change from baseline in overall severity of the clinical picture

时间窗: Baseline, after 4 weeks of treatment

Occurrence of Adverse Events

时间窗: up to 4 weeks

Change from baseline in breathlessness on Physical exercise

时间窗: Baseline, after 4 weeks

Change from baseline in breathlessness during housework

时间窗: Baseline, after 4 weeks

Change from baseline in breathlessness during everyday activities

时间窗: Baseline, after 4 weeks

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

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