RecruitingNCT06712563

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

Pooled Analysis of Multi-country, Open-label Single-arm, Non-interventional, Multi-center, Cohort Studies of Real-world Outcomes in New Users of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting

Sponsor

AstraZeneca

Enrollment

2,000 participants

Start Date

Apr 17, 2025

Study Type

OBSERVATIONAL

Conditions

Pulmonary Disease, Chronic Obstructive

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

Min Age: 18 Years

Inclusion Criteria3

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 Criteria1

Did not provide consent for secondary use of data

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Interventions

DRUGBudesonide/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