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Active, not recruiting Observational

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

NCT06712563 · tracked via the Priya Life Science Canada tracker
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
No
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)

FacilityCityRegionStatus
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
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 Canada