Real-World Outcomes in COPD Patients Starting Trixeo (Budesonide/Glycopyrronium/Formoterol) in Spain.

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— ORESTES  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06321731
• Other study ID #: D5980R00096
• Status: Not yet recruiting
• Start date: April 30, 2024
• Est. completion date: November 30, 2024

Study information

• Verified date: March 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 130 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Annualized rate of severe cardiovascular (CV)-related outcomes after initiation of BGF.	CV-related outcomes occurred after treatment initiation: tachyarrhythmias, heart failure (HF), and myocardial infarction (MI) and stroke, measured by the number of events per year and severity, and as a time to event variable, from treatment initiation.	Up to 12 months
Other	Mortality (% and time to event) after BGF initiation	2. Patient's mortality will be measured by percentage of deaths and reason of deaths (CV-related, respiratory-related, other) and as a time to event variable, from treatment onset to occurrence of death.	Up to 12 months
Primary	Annualized rate of exacerbations after BGF initiation	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).	Up to 12 months
Secondary	Demographic and clinical profile of patients initiating BGF.	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).	Index date (BGF initiation) and baseline (previous 12 months)
Secondary	Lung Function after BGF initiation	Measured by forced expiratory volume at first second (FEV1), FEV1 of the predicted %, forced vital capacity (FVC) volume and % FEV1/FVC	Up to 12 months
Secondary	Eosinophils count after BGF initiation	Counts in cells/µL	Up to 12 months
Secondary	Persistence to treatment (BGF)	Duration time from initiation to discontinuation of treatment	Up to 12 months
Secondary	Need for rescue medication after BGF initiation	Number of uses per year and time to first use	Up to 12 months
Secondary	Use of oral corticosteroids (OCS) after BGF initiation	Frequency and cumulative dosage (mg)	Up to 12 months
Secondary	HCRUs related to COPD after BGF initiation	Annualized rate of specialist visits, general practitioner (GP) visits, ER admissions and hospitalizations (along with duration)	Up to 12 months