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

NCT ID: NCT06712563

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-17

Study Completion Date

2026-09-04

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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BGF Initiators

New initiators of BGF without prior BGF exposure

Budesonide/glycopyrrolate/formoterol fumarate

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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BGF, Breztri

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Iqvia Pty Ltd

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael F Pollack, MS

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca

Locations

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Research Site

Mississauga, , Canada

Site Status NOT_YET_RECRUITING

Research Site

Hamburg, , Germany

Site Status RECRUITING

Research Site

Athens, , Greece

Site Status RECRUITING

Research Site

Milan, , Italy

Site Status RECRUITING

Research Site

Tokyo, , Japan

Site Status RECRUITING

Research Site

Bucharest, , Romania

Site Status NOT_YET_RECRUITING

Research Site

London, , United Kingdom

Site Status RECRUITING

Countries

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Canada Germany Greece Italy Japan Romania United Kingdom

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

1-877-240-9479

Other Identifiers

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D5980R00084

Identifier Type: -

Identifier Source: org_study_id

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