Real-world outcomes of Budesonide/Glyccopyronium/Formoterol therapy in COPD after 6 months; interim results of the RECORD study

RECORD, an observational single-arm cohort study, investigates effectiveness of Budesonide/Glycopyrronium/Formoterol (BGF) therapy in COPD patients (pts) from Germany and United Kingdom over 12 months. Pts with COPD were enrolled after initiating BGF according to label (index date).

The study evaluates patient- and physician-reported outcomes at baseline and 1, 3, 6, and 12 months post-index. Here we present the latest available 6-month (M6) results from Germany, with final data to be presented at the conference. M6 focuses on the CAT questionnaire, as well as exacerbations and lung function. Mean (SD) changes are presented here and in the table.

There were 436 pts at BL and 264 pts at M6; 43.1% were female. The annualised exacerbation rate (AER) decreased by 0.22 exacerbations per patient (95% CI: -0.33 to -0.10) in the 6 months post-index compared to the year before (n=264). FEV₁% predicted changed by 2.7% (14.0%) (n=132). Change in CAT was -3.5 (8.7) and 56.0% (95% CI: 48.1% to 63.7%, n=166) had an improvement of≥2 points (MCID). Greater improvements in FEV₁% predicted and CAT were seen in pts who escalated from LABA/LAMA or LABA/ICS [FEV₁%: 2.4% (15.1%), n=84; 6.5% (12.4%), n=29; CAT: -4.7 (8.7), n=103; -4.4 (7.9), n=33] compared to those on prior triple therapy [FEV₁%: 2.2% (9.8%), n=19; CAT: 1.6 (7.8), n=30]. Improvement in FEV₁% predicted was also greater for pts with cardiovascular disease (CVD) [3.5% (12.1%), n=86], but CAT improved equally in pts with and without CVD [-3.4 (8.8), n=115; -3.6 (8.5), n=51].

Interim data suggests that health status of moderate to severe COPD patients can be improved through optimised therapy.

Study funded by AstraZeneca.

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Publikationsverlauf

Artikel online veröffentlicht:
18. März 2025