Quality of Life and Preference of COPD Patients After Switching From Tiotropium Monotherapy (Spiriva® Handihaler®) to Dual Therapy With Tiotropium Bromide Plus Olodaterol (Spiolto® Respimat®) Under Real Life Conditions in Greece (ELLACTO II Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,396
- 试验地点
- 2
- 主要终点
- Change From Baseline in Patients' Quality of Life (QoL) According to the Total Score of COPD Assessment Test (CAT) at Month 3
研究概览
简要总结
The primary objective of this non-interventional study (NIS) is to evaluate changes within 3 months in quality of life according to health status evaluated with the COPD Assessment Test (CAT) in COPD patients who have recently switched (within one week) from tiotropium monotherapy (Spiriva® Handihaler®) to dual therapy with tiotropium bromide plus olodaterol (Spiolto® Respimat®), in the Greek private and public sector pulmonary offices and clinics.
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
- •Female and male patients ≥40 years of age
- •Patients diagnosed with COPD who have been using tiotropium administered with Spiriva® Handihaler® for at least 3 months before a recent switch (within last week) to a combination therapy with tiotropium bromide plus olodaterol administered with Spiolto® Respimat® has been made
- •Written informed consent prior to participation
- •Patient should be able to read, comprehend and complete study questionnaires
排除标准
- •Patients with contraindications according to Spiolto® Respimat® SmPC
- •Patients who have been treated with inhaled corticosteroids (ICS) as maintenance therapy* or with a Long-acting beta2 adrenoceptor agonist (LABA)/Long-acting muscarinic antagonist (LAMA) combination (free or fixed dose) in the previous 6 weeks
- •*Note: patients with temporary corticosteroids (CS) use during acute exacerbations in the previous 6 weeks can enter the study
- •Patients who have been treated with Spiriva® Respimat®, with other LAMA different than Spiriva®, or with a combination of Spiriva®+LABA/ICS in the previous 6 weeks
- •Patients diagnosed with asthma or with asthma COPD overlap syndrome (ACO)
- •Patients for whom availability at the enrolling site during the planned study period of approximately 3 months is not possible
- •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.
- •Further exclusion criteria apply.
研究组 & 干预措施
COPD patients
COPD patients switching from Tiotropium monotherapy to dual therapy with Tiotropium bromide plus Olodaterol.
All eligible Chronic Obstructive Pulmonary Disease (COPD) patients who had recently switched (within one week) from tiotropium monotherapy (Spiriva® Handihaler®) to dual therapy with tiotropium bromide plus olodaterol (Spiolto® Respimat®), in the Greek private and public sector pulmonary offices and clinics. The follow-up period was 3 months. Participants were visited at baseline (Visit 1) and at 3 months after baseline visit (Visit 2).
干预措施: Tiotropium bromide plus Olodaterol (Drug)
结局指标
主要结局
Change From Baseline in Patients' Quality of Life (QoL) According to the Total Score of COPD Assessment Test (CAT) at Month 3
时间窗: At baseline and at 3 months after baseline.
The CAT is a patient-completed questionnaire assessing globally the impact of COPD on health status. It contains 8 items, where each item has a score range from 0 to 5. The CAT score is calculated by summing up the scores from the 8 items. CAT score ranges from 0 to 40. Higher score denotes a more severe impact of COPD on a patient's life. CAT score \<10 corresponding to mild impact on patients life is usually considered representing patients without impaired health status.
次要结局
- Percentage of Patients With CAT≥10 at Baseline and Month 3(At baseline and at 3 months after baseline.)
- Change From Baseline in the Total European Quality of Life-Visual Analogue Scale (EQ-VAS) at Month 3(At baseline and at 3 months after baseline.)
- Percentage of Patients With Improved / Worsened Condition Mobility According to the European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Questionnaire After 3 Months(At baseline and at 3 months after baseline.)
- Number of Patients Per Medication Frequency Category According to Simplified Medication Adherence Questionnaire (SMAQ)(At 3 months after baseline.)
- Percentage of Patients With Improved / Worsen Condition in Self-care According to the European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Questionnaire After 3 Months(At baseline and at 3 months after baseline.)
- Percentage of Patients With Improved / Worsen Condition Anxiety/Depression According to the European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Questionnaire After 3 Months(At baseline and at 3 months after baseline.)
- Total Score in Abbreviated Patient Satisfaction and Preference Questionnaire (PASAPQ)(At 3 months after baseline.)
- Overall Satisfaction of Inhaler(At 3 months after baseline.)
- Percentage of Patients by Preference for Inhaler(At 3 months after baseline.)
- Percentage of Patients With Improved / Worsen Condition Usual Activities According to the European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Questionnaire After 3 Months(At baseline and at 3 months after baseline.)
- Percentage of Patients With Improved / Worsen Condition Pain/Discomfort According to the European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Questionnaire After 3 Months(At baseline and at 3 months after baseline.)
- Percentage of Patients With Adherence to the Medication(At 3 months after baseline.)
- Willingness to Continue With Inhaler(At 3 months after baseline.)
- Change From Baseline of Patients' Dyspnea Status According to the Modified Medical Research Council (mMRC) Scale at Month 3(At baseline and at 3 months after baseline.)
- Number of Patients Adherence to Medication of COPD Patients According to the Simplified Medication Adherence Questionnaire (SMAQ) Three-months After the Switch(At 3 months after baseline.)
- Days of Missed Medication for COPD(up to 3 months)