NCT00540163已完成不适用
Improvement in Physical Functioning (SF-36 Activity Score) in COPD Patients With Exercise-induced Dyspnoea on Treatment With Spiriva® 18 Microgram (Capsules Containing 18 μg Tiotropium).
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,296
- 试验地点
- 1
- 主要终点
- The primary endpoint was the proportion of patients with an improvement by ≥10 points in the standardised PF-10 score after 6 weeks of treatment with Spiriva® 18 Microgram
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 with exercise-induced dyspnoea on treatment with Spiriva (tiotropium 18 µg capsules) and allows adverse events to be recorded and evaluated.
详细描述
Study Design:
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
- •Men or women with COPD and a thoracic gas volume (TGV) of < 140% at rest, MRC value of 2 or more.
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.
- •Tiotropium bromide inhalation powder is contraindicated in patients with a hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to the excipient lactose monohydrate which contains milk protein.
结局指标
主要结局
The primary endpoint was the proportion of patients with an improvement by ≥10 points in the standardised PF-10 score after 6 weeks of treatment with Spiriva® 18 Microgram
时间窗: 6 weeks
次要结局
- The secondary endpoint was the change in the standardised PF-10 score within 6 weeks of treatment with Spiriva® 18 Microgram(6 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Observational Non-Interventional Study With Spiriva Respimat in COPD PatientsPulmonary Disease, Chronic ObstructiveNCT00699699Boehringer Ingelheim1,280
已完成
不适用
A study of improvement effects on physical functions by ingesting a food ingredient.Elderly male/female subjectsJPRN-UMIN000047871CPCC Company Limited60
终止
不适用
Assessment of Physical Functioning and Handling of Spiolto Respimat in Patients With COPD (OTIVACTO)Pulmonary Disease, Chronic ObstructiveNCT02720757Boehringer Ingelheim132
已完成
不适用
Physical Activity to Improve Physical Function in a Community-Based Health MinistryAgingMobility LimitationNCT04203030Rush University Medical Center15
已完成
不适用
Exploratory study on improvement of physical ability by voluntary training for type 2 diabetic patientsType 2 diabeticsJPRN-UMIN000039235niversity of Tsukuba Hospital30