Real-World Effectiveness of Budesonide/Glycopyrronium/Formoterol (BGF) Fixed-Dose Combination in Patients with COPD (RECORD Study): A Prospective Observational Study
9 affiliations
- 1Medical Department III (Respiratory Medicine), University of Luebeck, Luebeck, Germany
- 2Airway Research Center North (ARCN), German Center for Lung Research (DZL), Luebeck, Germany
- 3Real World Evidence, AstraZeneca, London, UK
- 4Clinical Operations, Alcedis, Giessen, Germany
- 5Real World Evidence, IQVIA, Frankfurt, Germany
- 6Department of Respiratory Medicine, Musgrove Park Hospital, Taunton, UK
- 7Division of Immunology, Immunity to Infection and Respiratory Medicine, University of Manchester, Manchester, UK
- 8Medicines Evaluation Unit, an IQVIA Business, Manchester, UK
- 9Medical Evidence, AstraZeneca, Hamburg, Germany
Abstract
Aim: To evaluate the real-world effectiveness of budesonide/glycopyrronium/formoterol (BGF) fixed-dose combination regarding clinical and patient-reported outcomes (PRO) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) in routine care.
Methods: This prospective, single-arm observational, multi-center study collected data via electronic forms and PRO questionnaires. The primary outcome evaluated change in COPD assessment test (CAT) scores from baseline to 3 months of therapy. Secondary outcomes included change in the St. George’s Respiratory Questionnaire (SGRQ), Treatment Satisfaction Questionnaire for Medication (TSQM-9), and annualized exacerbation rates (AER) over 12 months.
Results: The study enrolled 571 patients with COPD from Germany (n=441) and the United Kingdom (UK, n=130) prescribed BGF fixed-dose combination per routine care. Overall, the mean age was 65.5 years (Germany 64.8; UK 68.1), 55.9% were male (Germany 56.5%; UK 53.8%). Baseline CAT was 20.4 (Germany 19.5; UK 23.6), and the SGRQ score was 49.7 (Germany 47.3; UK 58.1). Prior 12-month exacerbations were reported by 35.6% overall (Germany 28.9%; UK 58.6%). Overall, 60.6% had cardiovascular comorbidities, including 46.2% with hypertension; cardiovascular disease rates were similar across countries, but asthma, depression, chronic kidney disease, and osteoarthritis were higher in the UK. At 3 months, CAT improved by −3.28 overall (95% confidence interval [CI] −4.31 to −2.26; Germany −3.49; UK −2.38); minimum clinically important difference was achieved in 58.2% (Germany 58.7%; UK 56.3%); SGRQ improved −7.04 overall (95% CI −9.09 to −5.00; Germany −7.57; UK −4.76); and TSQM-9 Global satisfaction increased 14.7 at 12 months (95% CI 10.61 to 18.85). AER fell from 0.74 to 0.45 (rate ratio 0.60; 95% CI 0.51 to 0.72).
Conclusion: BGF fixed-dose combination improved health status, quality of life, and reduced exacerbations in patients in this observational descriptive study. These findings complement evidence from clinical trials and suggest BGF fixed-dose combination has benefits for patients with moderate-to-severe COPD in routine care.
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BibTeX
@article{watz2026realworld,
title = {{Real-World Effectiveness of Budesonide/Glycopyrronium/Formoterol (BGF) Fixed-Dose Combination in Patients with COPD (RECORD Study): A Prospective Observational Study}},
author = {Henrik Watz and Michael Watt and Tamsin Morris and Matthias Saathoff and Annika Fernandez Milano and Dinesh Shrikrishna and Dave Singh and Marija Halbach},
journal = {International Journal of Chronic Obstructive Pulmonary Disease},
year = {2026},
month = oct,
doi = {10.2147/copd.s598569},
url = {https://doi.org/10.2147/copd.s598569},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Real-World Effectiveness of Budesonide/Glycopyrronium/Formoterol (BGF) Fixed-Dose Combination in Patients with COPD (RECORD Study): A Prospective Observational Study
AU - Henrik Watz
AU - Michael Watt
AU - Tamsin Morris
AU - Matthias Saathoff
AU - Annika Fernandez Milano
AU - Dinesh Shrikrishna
AU - Dave Singh
AU - Marija Halbach
PY - 2026
DA - 2026/10/30
JO - International Journal of Chronic Obstructive Pulmonary Disease
DO - 10.2147/copd.s598569
UR - https://doi.org/10.2147/copd.s598569
AB - Aim: To evaluate the real-world effectiveness of budesonide/glycopyrronium/formoterol (BGF) fixed-dose combination regarding clinical and patient-reported outcomes (PRO) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) in routine care. Methods: This prospective, single-arm observational, multi-center study collected data via electronic forms and PRO questionnaires. The primary outcome evaluated change in COPD assessment test (CAT) scores from baseline to 3 months of therapy. Secondary outcomes included change in the St. George’s Respiratory Questionnaire (SGRQ), Treatment Satisfaction Questionnaire for Medication (TSQM-9), and annualized exacerbation rates (AER) over 12 months. Results: The study enrolled 571 patients with COPD from Germany (n=441) and the United Kingdom (UK, n=130) prescribed BGF fixed-dose combination per routine care. Overall, the mean age was 65.5 years (Germany 64.8; UK 68.1), 55.9% were male (Germany 56.5%; UK 53.8%). Baseline CAT was 20.4 (Germany 19.5; UK 23.6), and the SGRQ score was 49.7 (Germany 47.3; UK 58.1). Prior 12-month exacerbations were reported by 35.6% overall (Germany 28.9%; UK 58.6%). Overall, 60.6% had cardiovascular comorbidities, including 46.2% with hypertension; cardiovascular disease rates were similar across countries, but asthma, depression, chronic kidney disease, and osteoarthritis were higher in the UK. At 3 months, CAT improved by −3.28 overall (95% confidence interval [CI] −4.31 to −2.26; Germany −3.49; UK −2.38); minimum clinically important difference was achieved in 58.2% (Germany 58.7%; UK 56.3%); SGRQ improved −7.04 overall (95% CI −9.09 to −5.00; Germany −7.57; UK −4.76); and TSQM-9 Global satisfaction increased 14.7 at 12 months (95% CI 10.61 to 18.85). AER fell from 0.74 to 0.45 (rate ratio 0.60; 95% CI 0.51 to 0.72). Conclusion: BGF fixed-dose combination improved health status, quality of life, and reduced exacerbations in patients in this observational descriptive study. These findings complement evidence from clinical trials and suggest BGF fixed-dose combination has benefits for patients with moderate-to-severe COPD in routine care.
SN - 1176-9106
SN - 1178-2005
ER -