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
- 1,737
- 主要终点
- Percentage of Patients With Therapeutic Success at Week 6 (Approx.) (Visit 2).
研究概览
简要总结
The primary objective of the study is to measure changes in physical functioning - serving as a surrogate for physical activity and exercise capacity - in COPD patients being treated with Spiolto® Respimat® after approximately 6 weeks. A secondary objective is to evaluate the patient¿s general condition (physician¿s evaluation) at visit 1 (baseline visit at the start of the study) and at visit 2 (final visit at the end of the study, approx. 6 weeks after visit 1), as well as patient satisfaction with Spiolto® Respimat® at visit 2.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
研究组 & 干预措施
Spiolto Respimat
COPD patients requiring a fixed combination therapy of two long-acting bronchodilators (LAMA + LABA) according to approved Summary of Product Characteristics (SmPC) and Global Initiative for Chronic Obstructive Lung Disease (GOLD)guidelines
干预措施: Spiolto Respimat (Drug)
结局指标
主要结局
Percentage of Patients With Therapeutic Success at Week 6 (Approx.) (Visit 2).
时间窗: after approximately 6 weeks
Therapeutic success defined as a minimum 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 sub-domain of the validated Short Form 36 (SF-36) quality of life questionnaire and consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. The total score ranges from 0 to 100. A higher score indicates a better physical functioning.
次要结局
- Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2).(Week 6 (approx.) (Visit 2))
- Changes in the PF-10 Score From Visit 1 to Visit 2(baseline and approx. week 6)
- General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2.(Baseline (Visit 1) and Week 6 (approx.) (Visit 2))
- Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2).(Week 6 (approx.) (Visit 2))
- Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2).(Week 6 (approx.) (Visit 2))