Assessment of Physical Functioning and Handling of Spiolto® Respimat® in Patients With Chronic Obstructive Pulmonary Disease (COPD) Requiring Long-acting Dual Bronchodilation in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 257
- 试验地点
- 78
- 主要终点
- Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2)
研究概览
简要总结
This is a self-controlled study design enrolling consented COPD patients who will be treated with Spiolto® Respimat® according to the approved SmPC. Patients will be enrolled consecutively and will be followed over an observational period of approx. 6 weeks.
详细描述
Purpose:
Study Design:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2)
时间窗: After approximately 6 weeks (visit 2)
Therapeutic success defined as at least 10-point increase of Physical functioning questionnaire (PF-10 ) score after approximately 6 weeks of Spiolto® Respimat® treatment. The PF-10 used for assessing the primary outcome "physical functioning" is a subdomain of the validated Short Form 36 (SF-36 ) and consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can be answered with "yes, limited a lot", "yes, limited a little" or "no, not limited at all", with a score of 1, 2 or 3. The sum of the scores of the 10 questions results in a value between 10 (a patient answering all questions with "yes, limited a lot") and 30 (a patient answering all questions with "no, not limited at all"). The final sum of the individual scores was standardized to a range of 0 to 100 using the following formula: \[(sum of scale items - 10) \* 100\] / 20. Higher scores indicate better physical functioning.
次要结局
- Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2(Baseline (visit 1) and after approx.week 6 (visit 2))
- Patient Satisfaction With Inhaling From the Respimat® Device(After approx. 6 weeks (visit 2) of treatment initiation)
- Patient Overall Satisfaction With Spiolto® Respimat® at Visit 2(After approx. 6 weeks (visit 2) of treatment initiation)
- The Mean Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2(Baseline (visit 1) and after approx. week 6 (visit 2))
- Patient Satisfaction With Handling of the Respimat® Inhalation Device(After approx. 6 weeks (visit 2) of treatment initiation)