Observational Retrospective Study To Describe Characteristics And Evaluate Real-World Outcomes in COPD Patients Initiating Trixeo Aerosphere (Budesonide/Glycopyrronium Bromide/Formoterol Fumarate) in Spain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 718
- 试验地点
- 1
- 主要终点
- Annualized rate of exacerbations after BGF initiation
研究概览
简要总结
The aim of the ORESTES study is to describe the characteristics of the COPD patients initiating Trixeo (BGF -budesonide/glycopyrronium/formoterol) in Spain and to assess their real-world outcomes up to 12 months afterwards.
For that purpose,a descriptive, observational, multi-centre, longitudinal, retrospective cohort study involving ~20 Spanish centres and aiming to include between 500 and 700 patients, has been designed.
详细描述
Chronic Obstructive Pulmonary Disease (COPD) is characterized by irreversible airflow obstruction, and it is a significant global health concern. According to the World Health Organization (WHO) COPD is the third leading cause of death worldwide, causing 3.23 million deaths in 2019. In Spain, around 12% of the population over 40 (approximately 2.2 million people) suffer from COPD, with an 11% mortality rate following hospitalization for a COPD exacerbation.
COPD exacerbations, associated with reduced quality of life, increased healthcare utilization, and substantial mortality, are more likely to recur in patients who have experienced one moderate or severe exacerbation. Traditionally, long-term bronchodilator therapy has been the primary pharmaceutical approach, including β2 agonists, anticholinergics, and inhaled corticosteroids (ICS). Triple therapy (TT), combining a long-acting β2 agonist (LABA), long-acting anticholinergic (LAMA), and ICS, is recommended for patients with persistent exacerbations.
Trixeo Aerosphere®, a fixed-dose combination of ICS/LABA/LAMA (budesonide/glycopyrronium bromide/formoterol fumarate, hereafter BGF) in a single inhaler, was approved in the European Union in December 2020 and marketed in Spain from February 2022. The Phase III ETHOS trial demonstrated significant reductions in moderate to severe exacerbations, improved quality of life, and lung function compared to dual therapies.
To assess real-world outcomes of patients initiating BGF in Spain, the ORESTES study has been designed.
The study primary objective is to describe the occurrence and severity of exacerbations of COPD-diagnosed patients receiving BGF from treatment initiation to end of treatment, loss to follow-up, death or up to 12 months of treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1 .Patient diagnosed with COPD confirmed by spirometry (postbronchodilator FEV1/FVC<0.7).
- •2. Patients treated with BGF initiated at least 12 months before start of data collection.
- •3. Patients with information available at least 12 months before BGF initiation.
- •4. Adult patients aged ≥40 years old at index date.
排除标准
- •Subjects with BGF treatment not intended for COPD (e.g., intended for asthma).
- •Subject participated in a clinical trial during the study data observation period.
结局指标
主要结局
Annualized rate of exacerbations after BGF initiation
时间窗: Up to 12 months
Annualized rate (total number of exacerbations divided by the total number of person years) of exacerbations occurred during the study data observation period after BGF initiation, overall and classified by severity (severe and moderate).
次要结局
- Use of oral corticosteroids (OCS) after BGF initiation(Up to 12 months)
- Eosinophils count after BGF initiation(Up to 12 months)
- Persistence to treatment (BGF)(Up to 12 months)
- Demographic and clinical profile of patients initiating BGF.(Index date (BGF initiation) and baseline (previous 12 months))
- Lung Function after BGF initiation(Up to 12 months)
- Need for rescue medication after BGF initiation(Up to 12 months)
- HCRUs related to COPD after BGF initiation(Up to 12 months)