Regulatory Requisite Post Marketing Surveillance to Assess the Safety and Efficacy of Spiriva® HandiHaler® (Tiotropium Bromide Inhalation Powder 18mcg, q.d.) in Korean COPD Patients: A 30-Day, Open Label, Non-interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,008
- 试验地点
- 71
- 主要终点
- The primary endpoint for this postmarking study is the occurrence of adverse events, anytime during the 30 day study period, which might or might not be connected with the use of Spiriva® 18 mcg inhalation capsule
研究概览
简要总结
This is a descriptive observational open non-comparative study of the safety and efficacy of tiotropium inhalation capsule given at 18mcg once a day for 30 days among Korean patients with COPD. At Visit 1, patients who are diagnosed as COPD will be prescribed tiotropium inhalation capsule at 18mcg once daily (at the same time). Patients' FEV1 will be assessed before start of treatment (Visit 1) and at the end of the 30 day treatment period (Visit 2). Occurrence of adverse events will also be asked from the patient at the end of the 30 day treatment period. Patients will be informed by the attending physicians to immediately report the occurrence of serious adverse events.
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
- •Older than 40 years old Diagnosed as COPD No Previous Spiriva administration No Contraindication for Spiriva according to the product label
排除标准
- •patients with history of hypersensitivity to atropine and its derivatives (e.g. ipratropium oxitropium or any component of this product).
结局指标
主要结局
The primary endpoint for this postmarking study is the occurrence of adverse events, anytime during the 30 day study period, which might or might not be connected with the use of Spiriva® 18 mcg inhalation capsule
时间窗: 30 days
次要结局
- Secondary endpoints include change in post bronchodilator FEV1 and assessment of any change in overall severity of the disease from baseline to the end of 30 day treatment.(30 days)