Real-world outcomes of Budesonide/Glycopyrronium/Formoterol therapy in COPD after 3 months; Interim analysis of the RECORD study

RECORD is an observational single arm cohort study investigating effectiveness of Budesonide/Glycopyrronium/Formoterol (BGF) therapy in COPD patients (pts) from Germany and United Kingdom over 12 months. Pts with COPD were enrolled following initiation of BGF according to label. Outcomes — including COPD Assessment Test (CAT), St. George's Respiratory Questionnaire (SGRQ), treatment satisfaction (TSQM-9) and medication adherence (MARS‐5) — were measured at baseline (BL), 1, 3, 6, and 12 months post-initiation. Herein we present interim results at 3 months (M3). There were 555 pts at BL and 489 pts at M3. At BL 43.4% were female, 36.8% had experienced exacerbation(s) in the prior 12 months (35.1% had moderate, 6.1% severe). Pts mean (SD) % predicted FEV1 was 56.2% (18.5%) at BL (n=314) and 60.3% (18.8%) at M3 (n=152). PRO outcomes at BL and M3 are presented in the table. Mean change in CAT at M1 was -3.3 (SD 6.8, n=274); 59.9% (95% CI 53.8% – 65.7%, n=274) and 59.5% (95% CI 53.1%–65.7%, n=247) had an improvement in CAT score of ≥2 points (minimal clinically important difference [MCID]) at M1 and M3, respectively. Interim data suggests pts experience improvements in PRO scores and lung function at M3 following BGF. <fig><object-id>erj;64/suppl_68/PA3909/F1</object-id><object-id>F1</object-id><object-id>F1</object-id><graphic></graphic></fig> Study funded by AstraZeneca

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Published
2024-09-14
DOI
https://doi.org/10.1183/13993003.congress-2024.pa3909
Primary Topic
Chronic Obstructive Pulmonary Disease (COPD) Research
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article
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article

Real-world outcomes of Budesonide/Glycopyrronium/Formoterol therapy in COPD after 3 months; Interim analysis of the RECORD study

Angelo Milano, Tamsin Morris, Dinesh Shrikrishna, M Saathoff et al.
Chronic Obstructive Pulmonary Disease (COPD) Research
article

Real-world outcomes of Budesonide/Glycopyrronium/Formoterol therapy in COPD after 3 months; Interim analysis of the RECORD study

Angelo Milano, Tamsin Morris, Dinesh Shrikrishna, M Saathoff, Michael Watt, Dave Singh, Henrik Watz, Marija Halbach
article en

Abstract

RECORD is an observational single arm cohort study investigating effectiveness of Budesonide/Glycopyrronium/Formoterol (BGF) therapy in COPD patients (pts) from Germany and United Kingdom over 12 months. Pts with COPD were enrolled following initiation of BGF according to label. Outcomes — including COPD Assessment Test (CAT), St. George's Respiratory Questionnaire (SGRQ), treatment satisfaction (TSQM-9) and medication adherence (MARS‐5) — were measured at baseline (BL), 1, 3, 6, and 12 months post-initiation. Herein we present interim results at 3 months (M3). There were 555 pts at BL and 489 pts at M3. At BL 43.4% were female, 36.8% had experienced exacerbation(s) in the prior 12 months (35.1% had moderate, 6.1% severe). Pts mean (SD) % predicted FEV1 was 56.2% (18.5%) at BL (n=314) and 60.3% (18.8%) at M3 (n=152). PRO outcomes at BL and M3 are presented in the table. Mean change in CAT at M1 was -3.3 (SD 6.8, n=274); 59.9% (95% CI 53.8% – 65.7%, n=274) and 59.5% (95% CI 53.1%–65.7%, n=247) had an improvement in CAT score of ≥2 points (minimal clinically important difference [MCID]) at M1 and M3, respectively. Interim data suggests pts experience improvements in PRO scores and lung function at M3 following BGF. <fig><object-id>erj;64/suppl_68/PA3909/F1</object-id><object-id>F1</object-id><object-id>F1</object-id><graphic></graphic></fig> Study funded by AstraZeneca

Musgrove Park Hospital (GB), University of Manchester (GB), IQVIA (United Kingdom) (GB), ImageCat (United Kingdom) (GB), Mammazentrum Hamburg (DE), LungenClinic Grosshansdorf (DE)
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Chronic Obstructive Pulmonary Disease (COPD) Research
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