Changes in Health and Functional Status in Patients With Chronic Obstructive Pulmonary Disease (COPD) During Therapy With Spiolto® Respimat® [ELLACTO]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,360
- 试验地点
- 4
- 主要终点
- Percentage of Patients Achieving "Therapeutic Success" Defined as a ≥ 0.4 Point of Decrease in the Clinical COPD Questionnaire (CCQ) Score
研究概览
简要总结
Open-label observational study: including COPD patients 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
- 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
- •Therapeutic indication before entering the enrollment face is patients diagnosed with COPD requiring a combination therapy of two long-acting bronchodilators (LAMA + LABA) according to approved SmPC and guidelines, COPD GOLD 2017 groups B to D
- •Female and male patients ≥40 years of age
- •Treatment with Spiolto ® Respimat® acc. to SmPC and at the discretion of the physician
- •Written informed consent prior to participation
排除标准
- •Patients with contraindications according to Spiolto® Respimat® SmPC
- •Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in the previous 6 weeks or patients already on a combination of LAMA and LABA therapy; either as a fixed combination product or as separate components Note: Patients previously treated with LABA or LAMA (with or without ICS) are eligible to be included in the study
- •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
- •Patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks
- •Pregnancy and lactation
- •Patients currently listed for lung transplantation
- •Current participation in any clinical trial or any other non-interventional study of a drug or device
研究组 & 干预措施
COPD patients
Chronic obstructive pulmonary disease
干预措施: MaxSpiolto® Respimat® 160 Characters... (Drug)
结局指标
主要结局
Percentage of Patients Achieving "Therapeutic Success" Defined as a ≥ 0.4 Point of Decrease in the Clinical COPD Questionnaire (CCQ) Score
时间窗: Between visit 1 (baseline visit at study start) and visit 2 (final visit after end of study, approximately 6 weeks after visit 1).
Therapeutic success was defined as ≥0.4 point decrease in the Clinical COPD Questionnaire (CCQ) score between visit 1 (baseline visit at study start) and visit 2 (final visit at end of study, approximately 6 weeks after visit 1). The CCQ 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 (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The sum of the scores divided by 10 gives the CCQ score. 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 CCQ score.
次要结局
- Absolute Change in Clinical COPD Questionnaire (CCQ) Score Between Visit 1 and Visit 2(At visit 1 (baseline visit at study start) and at visit 2 (final visit at end of study, approximately 6 weeks after visit 1).)
- Patients Satisfaction With Spiolto® Respimat® at Visit 2(At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit).)
- Absolute Change in the Functional Status Subdomain of Clinical COPD Questionnaire (CCQ-4) Score Between Visit 1 and Visit 2(At visit 1 (baseline visit at study start) and at visit 2 (final visit at the end of study, approximately 6 weeks after visit 1).)
- General Condition of Patient at Visit 1 and Visit 2(At visit 1 (baseline visit at study start) and at visit 2 (final visit at the end of study, approximately 6 weeks after visit 1).)
- Patients Preference for Spiolto® Respimat® at Visit 2(At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit))
- Patient's Willingness to Continue Treatment With Spiolto® Respimat® at Visit 2(At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit).)