A Prospective Non-interventional Trial on COPD Patients' Health Related Quality of Life Under a Fixed LAMA/LABA/ICS Triple Therapy and Characterization of Determinants of Treatment Adherence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Assess change in health related quality of life in COPD patients prescribed Trimbow
研究概览
简要总结
This is a prospective non-interventional trial to measure the health related quality of life of patients with chronic obstructive pulmonary disease (COPD) on a fixed LAMA/LABA/ICS triple therapy (Trimbow®) and characterisation of determinants of treatment adherence.
详细描述
The primary goal of COPD therapy is the prevention of exacerbations and clinical deterioration. To achieve these goals, treatment adherence (i.e. taking medication as prescribed) is important. However, non-adherence (not taking medication as prescribed) is common in COPD and can be affected by lifestyle changes or use of multiple inhalers.
The effects of Trimbow® on patients' health related quality of life, adherence and clinical outcomes have not been assessed in a UK real-world setting. This non-interventional trial aims to collect data from COPD patients under routine care over a 6 month period, for whom their doctors has decided to prescribe Trimbow® as per the authorised indication. We plan to investigate any changes in quality of life, as well as changes in lung function and the need for any additional therapy over 6 months. We also plan to investigate the adherence or reasons for non-adherence to Trimbow® as used in everyday routine.
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
- 35 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with moderate to severe COPD (with and without concomitant asthma)
- •Physician decision to start therapy with Trimbow as per its current marketing authorisation; the treatment decision should be made independently from participation in this Non-Interventional Trial
- •Patients with at least one COPD exacerbation within the previous 12 months
- •Patients willing and able to sign informed consent for use of their pseudonymised clinical data within the present Non-Interventional Trial
排除标准
- •Patients hospitalised due to an exacerbation of their COPD within the last 4 weeks prior to enrolment
- •Participation within an interventional clinical trial within 30 days prior to enrolment into the present Non-Interventional Trial
结局指标
主要结局
Assess change in health related quality of life in COPD patients prescribed Trimbow
时间窗: 6 months
Change in total CAT score between baseline and after 6 months of treatment.
次要结局
- Compare requirement of rescue medication and alteration of COPD therapy(6 months)
- changes in relevant spirometry parameters(6 months)
- incidence of clinical events(6 months)
- Assess adherence to COPD therapy(6 months)