Actively Recruiting
Pooled Analysis of Multi-country, Open-label Single-arm Studies on Real-world Outcomes in New Users of Budesonide/Glycopyrronium/Formoterol (BGF) for COPD
Led by AstraZeneca · Updated on 2026-05-19
2000
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
I
IQVIA Pty Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a pooled analysis of data from multiple ongoing and planned non-interventional studies involving adults with moderate to severe chronic obstructive pulmonary disease (COPD). These studies are sponsored by AstraZeneca and take place in various countries including the United Kingdom, Germany, Italy, Greece, Japan, Canada, and Romania. The purpose is to understand real-world outcomes in patients who start treatment with budesonide/glycopyrronium/formoterol (BGF). The analysis focuses on new users of BGF, a triple fixed-dose combination drug designed for adults whose COPD is not adequately managed by other inhaled therapies. This study collects data from routine care settings without altering standard treatment. It includes patients who have initiated BGF according to local prescribing guidelines and their physician's recommendation. Participants' involvement includes providing consent for the secondary use of their data collected during the original studies. Researchers will evaluate outcomes such as changes in the COPD Assessment Test (CAT) scores at 4, 12, and 52 weeks, treatment satisfaction, and the annual rate of COPD exacerbations. This retrospective analysis allows for a comprehensive understanding of BGF use and its impact over time in real-world clinical practice.
CONDITIONS
Brief Title
Pooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with moderate to severe COPD starting BGF treatment as recommended by their doctor
- Enrolled in ongoing single-arm studies
- Provided consent for secondary use of their data
You will not qualify if you...
- Did not provide consent for secondary use of data
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 52 weeks
Participants receive Budesonide/glycopyrrolate/formoterol fumarate (BGF) as part of their routine care for COPD.
Visits at 4 weeks, 12 weeks, and 52 weeks for assessments
Trial Site Locations
Total: 7 locations
1
Research Site
Mississauga, Canada
Not Yet Recruiting
2
Research Site
Hamburg, Germany
Actively Recruiting
3
Research Site
Athens, Greece
Actively Recruiting
4
Research Site
Milan, Italy
Actively Recruiting
5
Research Site
Tokyo, Japan
Actively Recruiting
6
Research Site
Bucharest, Romania
Not Yet Recruiting
7
Research Site
London, United Kingdom
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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