Pooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting

NCT06712563 · tracked via the Priya Life Science UK tracker

Sponsor

AstraZeneca

Phase

Observational

Started

2025-04-17

Last updated

2026-07-22

Condition(s) studied

Pulmonary Disease, Chronic Obstructive

Investigational drug(s) / intervention(s)

Budesonide/glycopyrrolate/formoterol fumarate

Budesonide/glycopyrrolate/formoterol fumarate: Budesonide/glycopyrrolate/formoterol fumarate (BGF) is a triple fixed-dose combination therapy for adults with moderate to severe COPD who are not adequately treated by a combination of inhaled corticosteroids and long-acting beta-agonist (LABA), or LABA and long-acting muscarinic-antagonist

Study summary

The CHOROS pooled analysis is a retrospective secondary data use analysis of integrated individual participant data from a series of planned and on-going primary prospective, non-interventional, multi-center studies sponsored by AstraZeneca and conducted in the pulmonary/primary care practitioner setting in multiple countries and may include data from the following countries: United Kingdom, Germany, Italy, Greece, Japan, Canada and Romania.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patients with moderate to severe COPD and initiating BGF treatment according to the local prescribing guidance and as per their treating physician's recommendation * Enrolled in on-going single-arm studies * Provided consent for secondary use of data Exclusion Criteria: * Did not provide consent for secondary use of data

Primary outcome measure(s)

COPD Assessment Test (CAT) — 12 weeks
Compare self-reported COPD health status measured by COPD Assessment Test (CAT) at 12 weeks/3 months as compared to baseline in patients initiating treatment with BGF

Trial sites (7)

Facility	City	Region
Research Site	Mississauga	Canada
Research Site	Hamburg	Germany
Research Site	Athens	Greece
Research Site	Milan	Italy
Research Site	Tokyo	Japan
Research Site	Bucharest	Romania
Research Site	London	United Kingdom

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06712563 on ClinicalTrials.gov ↗ ← All trials in the UK