AERIAL®: Changes in Health and Functional Status in Patients With COPD During Therapy With Spiolto® Respimat®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,351
- 试验地点
- 106
- 主要终点
- Therapeutic Success
研究概览
简要总结
The objective of this NIS is to measure changes in health status including functional status using CCQ scores in COPD patients receiving treatment with Spiolto® Respimat® according to label after approximately 6 weeks in routine clinical practice.
详细描述
The objective of this NIS is to measure changes in health status including functional status using CCQ scores in COPD patients receiving treatment with Spiolto® Respimat® according to label after approximately 6 weeks in routine clinical practice.
In visit 1, patient data on demographics, smoking status, medical history, breathlessness, general condition, health and functional status and adverse drug reactions will be collected. In visit 2, after approximately 6 weeks, data on smoking status, concomitant diseases and medication, general condition, health and functional status and adverse drug reactions will be collected; additionally data on patient satisfaction, continuation or discontinuation of treatment and the reason in case of discontinuation.
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
- •Patients can be included if all of the following criteria are met:
- •Written informed consent prior to participation
- •Female and male patients ≥40 years of age
- •Patients diagnosed with COPD and requiring a combination of two long-acting bronchodilators (LAMA + LABA) according to approved SmPC and GOLD COPD guideline recommendation 2017 (GOLD COPD groups B to D)
- •Treatment with Spiolto® Respimat® acc. to SmPC at the discretion of the physician.
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
patients treated with Spiolto® Respimat®
Patients with COPD
干预措施: Spiolto® Respimat® (Drug)
结局指标
主要结局
Therapeutic Success
时间窗: Final visit at the end of the study, approximately 6 weeks after start of study
The primary endpoint of the study was "therapeutic success" at visit 2. The CCQ questionnaire contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was scored by the patient on a 7-point scale between 0 and 6 at baseline and at the end of observation after approximately 6 weeks. 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. A decrease of 0.4 points is considered to be the minimal clinically important difference (MCID) for both CCQ score and CCQ-4.
次要结局
- Patient Satisfaction With Spiolto® Respimat® at Visit 2(6 weeks)
- Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2(6 weeks)
- Assessment of Changes in CCQ and CCQ-4 From Visit 1 to Visit 2(Final visit at the end of the study, approximately 6 weeks after start of study)
- General Condition of the Patient(Baseline visit (Visit 1) at the start of the study and final visit at the end of the study (visit 2), approximately 6 weeks after visit 1)