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

Recruiting

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Budesonide/glycopyrrolate/formoterol fumarate

• Registration Number: NCT06712563
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-11-27
• Study First Posted: 2024-12-02
• Study Start: 2025-04-17
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21
• Primary Completion: 2026-09-04
• Study Completion: 2026-09-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BGF Initiators	Budesonide/glycopyrrolate/formoterol fumarate	New initiators of BGF without prior BGF exposure

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Annual rate of COPD exacerbations	52 weeks	To compare the annual rates of moderate and severe exacerbations for the follow-up period (up to 52 weeks/12 months) versus the baseline period (12 months prior to initiating BGF)
COPD Assessment Test	52 weeks	To compare self-reported COPD health status measured by CAT at 52 weeks/12 months as compared to baseline in patients initiating treatment with BGF
COPD Assessment Test Responder Rate	12 weeks	To describe the frequency and proportion of responders of the CAT questionnaire after 12 weeks/3 months of initiating treatment with BGF
Treatment Satisfaction Questionnaire for Medication (TSQM)	12 weeks and 52 weeks	To evaluate treatment satisfaction using Treatment Satisfaction Questionnaire for Medication (TSQM) after 12 weeks/3months and 52 weeks/12 months of initiating treatment with BGF

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom