Clinical and patient-reported outcomes of COPD patients after 12 weeks of treatment with Budesonide/Glycopyrronium/Formoterol: interim analysis of the CHOROS ORION real-life study in Italy

CHOROS ORION is a multicenter, non-interventional, single arm cohort study investigating the effectiveness of Budesonide/Glycopyrronium/Formoterol (BGF) in COPD patients (pts) in Italy. The study enrolled 250 COPD pts, aged ≥40, following initiation of BGF according to label and local regulations. Pts hospitalized due to acute COPD exacerbations in the 30 days prior to enrolment were excluded. Outcomes, including COPD Assessment Test (CAT) and Patient Global Impression of Severity (PGI-S) score, are measured at baseline (BL), 12, 26, 52 weeks (w) post BGF initiation. Herein we present interim results at 12w. Among eligible pts (230), males were 157 (68.3%); mean age was 71.2 years (SD 8.5); 190 (82.6%) had past or ongoing comorbidities, and 153 (66.5%) had past or ongoing cardiovascular conditions. Last COPD treatments prior to BGF were LABA/LAMA (113, 49.1%), ICS/LABA+LAMA (53, 23.0%) and ICS/LABA (52, 22.6%). Among the 152 pts that completed CAT at BL and 12w, mean change in CAT was -1.3 (95% CI -2.5 – -0.1) and 79 pts (52.0%) had an improvement of ≥ 2 points (minimum clinically important difference). 42 pts (27.9%) at BL and 28 pts (18.7%) at 12w reported severe/very severe PGI-S scores. Conversely, 43 pts (28.5%) at BL and 62 pts (41.3%) at 12w reported none/mild severity. At BL, the annualized exacerbation rate was 1.6 overall and 0.2 for severe, while during BGF it was 0.26 and 0.02, respectively. Interim data from CHOROS ORION suggest early symptoms and clinical improvement in COPD pts over 12w of treatment with BGF. Final study results will provide comprehensive evidence over 52 weeks.