Pooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting
CHOROS
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
1 other identifier
observational
2,000
7 countries
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2025
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2024
CompletedFirst Posted
Study publicly available on registry
December 2, 2024
CompletedStudy Start
First participant enrolled
April 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 14, 2026
April 21, 2026
April 1, 2026
1.7 years
November 27, 2024
April 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
COPD Assessment Test (CAT)
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
12 weeks
Secondary Outcomes (5)
COPD Assessment Test
4 weeks
COPD Assessment Test
52 weeks
COPD Assessment Test Responder Rate
12 weeks
Treatment Satisfaction Questionnaire for Medication (TSQM)
12 weeks and 52 weeks
Annual rate of COPD exacerbations
52 weeks
Study Arms (1)
BGF Initiators
New initiators of BGF without prior BGF exposure
Interventions
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
Eligibility Criteria
Patients with COPD who are new initiators of BGF enrolled in several planned and on-going prospective, non-interventional single-arm studies. Eligible patients for the individual studies are those with moderate to severe COPD and initiating BGF treatment according to the local prescribing guidance and as per their treating physician's recommendation. Only patients that have signed an informed consent form (ICF) allowing the secondary use of their data will be eligible for the CHOROS pooled analysis.
You may qualify if:
- 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
You may not qualify if:
- Did not provide consent for secondary use of data
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- IQVIA Pty Ltdcollaborator
Study Sites (7)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael F Pollack, MS
AstraZeneca
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2024
First Posted
December 2, 2024
Study Start
April 17, 2025
Primary Completion (Estimated)
December 14, 2026
Study Completion (Estimated)
December 14, 2026
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.