NCT00239460已完成3 期
Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With Chronic Obstructive Pulmonary Disease (a 12-week, Parallel Group, Randomized, Placebo-cotrolled, Double-blind Study).
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 12
- 主要终点
- Trough FEV1 after 12 weeks of treatment
研究概览
简要总结
The objective of this study is to evaluate the effect of inhaled tiotropium bromide on trough FEV1 and to assess the cardiac effects through 12-lead and Holter ECG monitoring in patients with COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- •History of COPD, FEV1 less than or equal to 65%, FEV1/FVC less than or equal 70%
- •Smoking history greater than or equal to 10 pack years
- •Not history of clinical diagnosis of asthma and/or atopy
- •A history of thoracotomy with pulmonary resection
- •Patients requiring the use of supplemental oxygen therapy for >12 hours per day
- •Chronic use of systemic corticosteroids in an unstable daily dose
- •Patients with a recent history of myocardial infarction
- •A known hypersensitivity to anticholinergic drugs
排除标准
- 未提供
结局指标
主要结局
Trough FEV1 after 12 weeks of treatment
时间窗: 12 weeks
次要结局
- Trough FVC at Visits 3 and 4(week 8 and week 12)
- Vital signs(week 8 and week 12)
- Trough FEV1 at Visit 3(week 8)
- 24-hour holter ECG monitoring(week 8 and week 12)
- FEV1 and FVC 90 min post study drug inhalation at all visits(90 minutes post-medication)
- Use of rescue medication(12 weeks)
- Patient's Global Evaluation(week 8 and week 12)
- Physician's Global Evaluation(week 8 and week 12)
- Adverse events(12 weeks)
- Physical Exam(week 12)
- 12-lead ECG(week 8 and week 12)
- Health Related Quality of Life assessed by the EQ5D at Visit 2 and 4(week 8 and week 12)
研究者
研究点 (12)
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