Efficacy of Budesonide/Glycopyrronium/Formoterol FDC across blood eosinophil ranges in Indian COPD patients: post-hoc analysis of a phase-IV clinical-trial

<bold>Background:</bold> Evidence is emerging on triple therapy in COPD patients (pts) with low blood eosinophil count(BEC); however, it is limited & unexplored in Indian pts. Budesonide/Glycopyrronium/Formoterol(BGF)(400/25/12mcg)-FDC-DPI was found to be safe & improved outcomes in Indian moderate-severe-COPD pts in Phase-IV trial1. In this post-hoc analysis, we evaluated treatment benefits based on baseline BEC <bold>Aim:</bold> To assess impact of triple therapy on symptoms, QoL & FEV1 in COPD pts with high/low BEC Method: An open-label, prospective, non-comparative, multicenter, 24 wk Phase-IV trial evaluated safety & efficacy of BGF-DPI twice-daily in spirometrically-diagnosed moderate-severe COPD(GOLD 2020)pts who were current/ex-smokers, had CAT-score>10 & able to use DPI. Efficacy outcomes evaluated in this post-hoc analysis(per-protocol) were change at 24 wks from baseline in CAT, SGRQ, & mMRC scores and trough-FEV1 in pts with high(>/=300)/ low(<300)BEC <bold>Results:</bold> Of 179 pts, 64.24% had BEC<300. Mean CAT score improvement(p<0.001) of 7.14 & 7.096 units & mean SGRQ improvement of 19.43 & 18.89 were seen in pts with high & low BEC, respectively. Mean mMRC improved by 0.313 and 0.261(p<0.001) in high & low BEC groups, respectively. Change in trough-FEV1 was 0.082+/-0.25ml(p=0.005) & 0.061+/-0.22ml(p=0.001) in high and low BEC groups, respectively. No significant difference in outcomes were noted between both groups; safety was comparable. <bold>Conclusion:</bold> Findings of this post-hoc analysis suggest that benefits of triple therapy are not restricted to patients with high BEC even in Indian population. 1. E-poster-NAPCON, Hyderabad, Nov30 - Dec3,2023