A Prospective Observational Study in COPD Patients Evaluating the Quality of Life in Patients Switching From a Dual Therapy to a Fixed LABA/LAMA/ICS Triple Therapy in Routine Practice
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 11
- 主要终点
- COPD symptoms
研究概览
简要总结
This non-interventional study aims to collect information on the patient's quality of life, as well as the quality of sleep when stepping up to a fixed triple maintenance therapy (Trimbow®) as per physicians' decision, independent from study participation, and to assess its effectiveness in daily life, in general practitioner setting.
详细描述
This non-interventional study assesses the real-life effectiveness, with focus on patient's quality of life, of the fixed triple therapy Trimbow® after stepping up from a dual therapy in clinical practice at first line centres in patients with confirmed chronic obstructive pulmonary disease (COPD). Data will be collected on availability as per usual care at baseline, 3 and 6 months after inclusion.
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
- •Patient has provided written informed consent
- •Patient is aged 40 years or older
- •Current or ex-smokers with a smoking history ≥ 10 pack years
- •Patient is diagnosed with COPD, confirmed by post-bronchodilator spirometry (Tiffeneau index <0.7; baseline or older spirometry)
- •Patient is eligible for switch to triple therapy with at least 12 weeks of stable double inhalation therapy (ICS/LABA or LABA/LAMA) prior to enrolment to the study
- •Patient is starting treatment with Trimbow® upon decision by their physician
排除标准
- •Patients who are hypersensitive to one of the active substances or excipients
- •Patients who are treated with triple therapy (via single or multiple inhalers) in the last 6 months prior to study enrolment
- •Patients on ICS, LABA or LAMA monotherapy
- •Patients with pneumonia and/or a moderate or severe COPD exacerbation not resolved ≥ 14 days prior to screening and ≥ 30 days following the last dose of oral/systemic corticosteroid (if applicable), or a respiratory tract infection not resolved ≥ 7 days prior to screening
- •Patients participating simultaneously to other clinical trials or studies
结局指标
主要结局
COPD symptoms
时间窗: 6 months
The patient's COPD symptoms at month 6 (visit 3), compared to baseline. This is measured by the COPD Assessment Test (CAT) questionnaire.
次要结局
- Rescue medication(6 months)
- COPD symptoms(3 months)
- Treatment satisfaction(6 months)
- Quality of sleep(6 months)
- Lung function parameters(6 months)