Analysis of Budesonide/Glycopyrronium/Formoterol for COPD treatment
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
This study is testing how well a combination medication called Budesonide/Glycopyrronium/Formoterol works for people with moderate to severe COPD in everyday healthcare settings.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 7 sites (Mississauga and 6 other locations) |
| Trial ID | NCT06712563 on ClinicalTrials.gov |
What this trial studies
This analysis examines data from multiple ongoing studies focusing on the use of Budesonide/Glycopyrronium/Formoterol (BGF) in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). It utilizes a pooled approach to integrate individual participant data from various countries, including the UK, Germany, Italy, Greece, Japan, Canada, and Romania. The study aims to evaluate the effectiveness and safety of BGF in routine care settings based on real-world evidence.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with moderate to severe COPD who are starting treatment with BGF as recommended by their healthcare provider.
Not a fit: Patients who do not consent to the secondary use of their data will not benefit from this study.
Why it matters
Potential benefit: If successful, this analysis could provide valuable insights into the effectiveness of BGF treatment for COPD patients in everyday clinical practice.
How similar studies have performed: Other studies utilizing similar pooled analysis approaches have shown promise in evaluating treatment effectiveness, suggesting this methodology is both valid and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Mississauga and 6 other locations
- Research Site — Mississauga, Canada (Not_yet_recruiting)
- Research Site — Hamburg, Germany (Recruiting)
- Research Site — Athens, Greece (Recruiting)
- Research Site — Milan, Italy (Recruiting)
- Research Site — Tokyo, Japan (Recruiting)
- Research Site — Bucharest, Romania (Not_yet_recruiting)
- Research Site — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Michael F Pollack, MS — AstraZeneca
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.