Clinical trial NCT06321731: Real-World Outcomes in COPD Patients Starting Trixeo (Budesonide/Glycopyrronium/Formoterol) in Spain.
Official title: Observational Retrospective Study To Describe Characteristics And Evaluate Real-World Outcomes in COPD Patients Initiating Trixeo Aerosphere (Budesonide/Glycopyrronium Bromide/Formoterol Fumarate) in Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-03-20
Enrollment: 553
Sex: ALL
Minimum age (years): 40
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include 500-700 COPD patients who started BGF treatment at least 12 months before start of data collection, and from approximately 20 hospitals in Spain.

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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

1. Subjects with BGF treatment not intended for COPD (e.g., intended for asthma).
2. Subject participated in a clinical trial during the study data observation period.

Primary outcomes:
measure: Annualized rate of exacerbations after BGF initiation
timeFrame: Up to 12 months
Secondary outcomes:
measure: Demographic and clinical profile of patients initiating BGF.
timeFrame: Index date (BGF initiation) and baseline (previous 12 months)
measure: Lung Function after BGF initiation
timeFrame: Up to 12 months
measure: Eosinophils count after BGF initiation
timeFrame: Up to 12 months
measure: Persistence to treatment (BGF)
timeFrame: Up to 12 months
measure: Need for rescue medication after BGF initiation
timeFrame: Up to 12 months
measure: Use of oral corticosteroids (OCS) after BGF initiation
timeFrame: Up to 12 months
measure: HCRUs related to COPD after BGF initiation
timeFrame: Up to 12 months
Other outcomes:
measure: Annualized rate of severe cardiovascular (CV)-related outcomes after initiation of BGF.
timeFrame: Up to 12 months
measure: Mortality (% and time to event) after BGF initiation
timeFrame: Up to 12 months
Locations:
city: Barcelona
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Lleida
country: Spain
facility: Research Site
city: Lugo
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Murcia
country: Spain
facility: Research Site
city: Ourense
country: Spain
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
city: Palma de Mallorca
country: Spain
facility: Research Site
city: Santa Cruz de Tenerife
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Vitoria
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
Study officials:
References: