Changes in Clinical Control of COPD Patients Measured by the Clinical COPD Questionnaire During Therapy With Spiolto®Respimat® in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,819
- 试验地点
- 386
- 主要终点
- Percentage of Patients With Therapeutic Success of Spiolto® Respimat® Treatment at Visit 2
研究概览
简要总结
Open-label observational study which includes COPD patients that are receiving treatment with Spiolto® Respimat® for approximately 6 weeks, which is the average time between two medical consultations.
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
- •Written informed consent prior to participation
- •Female and male patients ≥40 years of age
- •Patients diagnosed with COPD and based upon the investigator's decision requiring a new prescription of Spiolto Respimat® (combination of two long-acting bronchodilators) according to Spiolto® Respimat® SmPC, GOLD COPD Strategy Document 2018 (GOLD COPD groups B to D) and local COPD guidelines
排除标准
- •Patients with contraindications according to Spiolto® Respimat® SmPC
- •Patients already on a LABA/LAMA combination (free and fixed dose) in the last 6 weeks before study entry
- •Patients continuing LABA/ICS treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta-agonists
- •Pregnancy and lactation
- •Current participation in any clinical trial or any other non-interventional study of a drug or device.
研究组 & 干预措施
subjects with COPD
干预措施: Spiolto® Respimat® (Drug)
结局指标
主要结局
Percentage of Patients With Therapeutic Success of Spiolto® Respimat® Treatment at Visit 2
时间窗: At Visit 2 (6 weeks after baseline visit 1)
Therapeutic success of Spiolto® Respimat® treatment was defined as 0.4 point decrease in the Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire - Clinical COPD Questionnaire (CCQ) score from visit 1 to visit 2. Each of the 10 CCQ questions is scored by the patient on a 7-point scale between 0 (Never/Not limited at all) and 6 (Almost all the time/Totally limited or unable to do) at baseline (Visit 1) and at the end of the observation after approximately 6 weeks (Visit 2). The sum of the scores divided by 10 gives the CCQ score, which measures the health and functional status. A higher CCQ score is indicative of worse status.
次要结局
- Changes in the Clinical COPD Questionnaire (CCQ) and the CCQ Symptom, Mental State and Functional State Domain Scores From Visit 1 (Baseline) to Visit 2(At baseline visit 1 and 6 weeks thereafter at visit 2)
- Physician's Global Evaluation (PGE) Score at Visit 1(Baseline)(At visit 1)
- Physician's Global Evaluation (PGE) Score at Visit 2(At visit 2 (6 weeks after baseline visit 1))
- Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2(At visit 2 (6 weeks after baseline visit 1))
- Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2(At visit 2 (6 weeks after baseline visit 1))
- Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2(At visit 2 (6 weeks after baseline visit 1))
- Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2(At visit 2 (6 weeks after baseline visit 1))