Spiriva® 18µg Once Daily in Chinese COPD Patients of Different Disease Severities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,918
- 主要终点
- Patient Global Assessment of Chronic Obstructive Pulmonary Disease (COPD) Symptom at Visit 1 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good)
研究概览
简要总结
The objective of the present Post Marketing Surveillance Study (PMS) study is to evaluate safety and effectiveness of tiotropium bromide (Spiriva®) 18 µg once daily in 5,000 patients with COPD of varying severities over 8 weeks.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Incl. Criteria Patients with clinical diagnosis of stable Chronic Obstructive Pulmonary Disease (COPD) according to definition of China COPD guideline.
- •Patients over 40 years old
排除标准
- •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.,creatinin 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® China package insert
- •Patients with signed informed consent of any other study
结局指标
主要结局
Patient Global Assessment of Chronic Obstructive Pulmonary Disease (COPD) Symptom at Visit 1 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good)
时间窗: 0 weeks (Visit 1) and 8 weeks (Visit 3)
The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8; 1 point meaning most COPD-associated symptoms and signs and 8 point meaning least). Represents number of participants who score ""good"" and ""excellent"" at visit 1 (0 weeks) and visit 3 (8 weeks)
Patient Tolerability Assessment at Visit 3
时间窗: 8 weeks (Visit 3)
Patient tolerability assessment classified as "Unsatisfied", "Satisfied", "Good" and "Very Good"
次要结局
- Physician Global Assessment of Spiriva Effectiveness at Visit 2 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good)(2 weeks (Visit 2 and 8 weeks (Visit 3))
- Physician Tolerability Assessment at Visit 3(8 weeks (Visit 3))