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
- 终止
- 入组人数
- 132
- 主要终点
- Percentage of Patients With Therapeutic Success After Approximately (Approx.) 6 Weeks After Baseline
研究概览
简要总结
The primary objective of this Non Interventional Study is to measure changes in physical functioning, a surrogate for physical activity and exercise capacity, in COPD patients on treatment with Spiolto® Respimat® in routine daily treatment after approximately 6 weeks.
A secondary objective is to evaluate the patient's general condition (physician's evaluation) from Visit 1 (baseline visit at the start of the study) to 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 After Approximately (Approx.) 6 Weeks After Baseline
时间窗: Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)
"Therapeutic success" is defined as a 10-point increase of physical functioning (PF)-10 between Visit 1 (baseline) and Visit 2 (approx. 6 weeks later) using a PF questionnaire, which is a subdomain of the Short form (SF)-36 patient questionnaire. The PF-10 sub-domain 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 scores over the 10 questions will be summed, resulting 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 will be standardized to a range of 0 to 100 using the following formula: 100\*(sum-10)/20. Percentage of patients with therapeutic success after approximately 6 weeks after baseline are presented
次要结局
- General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later)(Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later))
- Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 (Approx. 6 Weeks Later)(Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later))
- Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction(Visit 2 (approx. 6 weeks post baseline))
- Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device(Visit 2 (approx. 6 weeks post baseline))
- Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device(Visit 2 (approx. 6 weeks post baseline))