Real-World Outcomes in COPD Patients Starting Trixeo (Budesonide/Glycopyrronium/Formoterol) in Spain.
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Registration Number
- NCT06321731
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
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.
The study secondary objectives are:
1. To describe the demographic and clinical profile of patients at the moment of BGF initiation.
2. To describe other patients' clinical outcomes (apart from exacerbations), treatment outcomes and healthcare resource utilisation (HCRU) after initiation of BGF.
The study exploratory objectives are:
1. To describe severe cardiovascular (CV)-related outcomes after initiation of BGF.
2. To describe the mortality after initiation of BGF.
Descriptive, observational multi-centre, longitudinal, retrospective cohort study aiming to include adult patients aged 40 years or older diagnosed with COPD and who initiated BGF at least 12 months before inclusion.
The study observation period runs from 12 months prior to the start of BGF, defined as the index date, until the censoring date, i.e., the earliest of BGF treatment discontinuation, loss to follow-up, death or maximum of 12 months after index date.
This study is based exclusively on secondary data collection from outpatient electronic medical records (EMRs). Therefore, it will rely on already existing data from patients by the time of data collection.
The study will include 500-700 patients from approximately 20 hospitals in Spain.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 553
1 .Patient diagnosed with COPD confirmed by spirometry (postbronchodilator FEV1/FVC<0.7).
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Patients treated with BGF initiated at least 12 months before start of data collection.
-
Patients with information available at least 12 months before BGF initiation.
-
Adult patients aged ≥40 years old at index date.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Annualized rate of exacerbations after BGF initiation 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).
- Secondary Outcome Measures
Name Time Method Use of oral corticosteroids (OCS) after BGF initiation Up to 12 months Frequency and cumulative dosage (mg)
Eosinophils count after BGF initiation Up to 12 months Counts in cells/µL
Persistence to treatment (BGF) Up to 12 months Duration time from initiation to discontinuation of treatment
Demographic and clinical profile of patients initiating BGF. Index date (BGF initiation) and baseline (previous 12 months) Patient demographics, comorbidities, clinical characteristics related to COPD and other respiratory-related variables such as lung function and dyspnoea, the presence of eosinophils, exacerbations, medication used for COPD, including OCS and rescue medication, and the healthcare resource use (HCRU).
Lung Function after BGF initiation Up to 12 months Measured by forced expiratory volume at first second (FEV1), FEV1 of the predicted %, forced vital capacity (FVC) volume and % FEV1/FVC
Need for rescue medication after BGF initiation Up to 12 months Number of uses per year and time to first use
HCRUs related to COPD after BGF initiation Up to 12 months Annualized rate of specialist visits, general practitioner (GP) visits, ER admissions and hospitalizations (along with duration)
Trial Locations
- Locations (1)
Research Site
🇪🇸Zaragoza, Spain