NCT00615992已完成不适用
Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 754
- 试验地点
- 1
- 主要终点
- Activities of Daily Living Score After 3 to 4 Weeks Treatment With Spiriva
研究概览
简要总结
The primary goal of this post marketing surveillance (PMS) study is to document the efficacy of Tiotropium (Spiriva) to improve physical activity measured by a score that is recommended in national chronic obstructive pulmonary disease (COPD) guidelines for monitoring the course of the disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with suspected chronic obstructive pulmonary disease (COPD)
- •3 or more positive answers in COPD questionnaire
- •Age over 40 years
排除标准
- •Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva in the summary of product characteristics
- •Patient treated with Spiriva in the past year
- •Patient with history of hypersensitivity to tiotropium bromide, atropine and/or its derivant, i.e. ipratropium, or any component of Spiriva Patient with known narrow-angle glaucoma Patient with known symptomatic prostatic hyperplasia and/or bladder-neck obstruction Patient with known moderate to severe renal impairment (i.e.,creatinine clearance<=50ml/min) Pregnant or nursing women Patient with any significant disease other than COPD which would exclude him/her from participating in the study Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva in Austrian summary of product characteristics
结局指标
主要结局
Activities of Daily Living Score After 3 to 4 Weeks Treatment With Spiriva
时间窗: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)
次要结局
- Dyspnea Score After 3 to 4 Weeks Treatment With Spiriva(Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days))
- Global Assessment of Efficacy by Patient(Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days))
- Global Assessment of Tolerability by Patient(Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days))
- Global Assessment of Efficacy by Physician(Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days))
- Global Assessment of Tolerability by Physician(Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Effect of Spiriva® on Health-related Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients Who Stopped Smoking During Treatment.Pulmonary Disease, Chronic ObstructiveNCT02172547Boehringer Ingelheim10,821
已完成
不适用
Effect of Spiriva® 18 Microgram on Health-related Quality of Life and Physical Functioning in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Proven HyperinflationPulmonary Disease, Chronic ObstructiveNCT02172521Boehringer Ingelheim1,536
已完成
不适用
Spiriva® in Patients With Chronic Obstructive Pulmonary Disease (COPD) in Daily PracticePulmonary Disease, Chronic ObstructiveNCT02172495Boehringer Ingelheim4,700
已完成
不适用
Spiriva® in Patients With Chronic Obstructive Pulmonary Disease (COPD)Pulmonary Disease, Chronic ObstructiveNCT02172482Boehringer Ingelheim63,127
已完成
不适用
Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs SyndromeRestless Legs SyndromeNCT00721279Boehringer Ingelheim549