Clinical stability under FF/UMEC/VI triple inhaled therapy: A 12-month real life retrospective observational study

Chronic Obstructive Pulmonary Disease (COPD) remains a leading cause of morbidity and mortality worldwide. For patients with a high disease burden, triple therapy with fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI) has demonstrated significant benefits in health-related quality of life (HRQoL), exacerbation reduction, and lung function improvement. Efforts have been made to define clinical stability (CS), yet real-world data on CS during FF/UMEC/VI therapy remain limited. This retrospective study aimed to assess the prevalence of CS after 12 months (T12) of FF/UMEC/VI treatment in COPD patients. CS was defined as the concurrent presence at T12 of: no acute exacerbations in the prior 12 months, a ≥ 2-point improvement in COPD Assessment Test (CAT) score from baseline, and a forced expiratory volume in 1 s (FEV₁) decline <100 mL. A total of 47 patients was included. Of them, 10 (21.3 %) achieved CS. These individuals had a lower baseline exacerbation rate (P = 0.020) and a trend toward better baseline lung function. They also demonstrated greater improvement in 6-min walking distance compared with non-CS patients (P = 0.048). These findings suggest that CS is attainable in routine clinical practice, with prevalence comparable to that observed in clinical trials. Patients achieving CS tended to have milder disease, indicating potential benefits of earlier FF/UMEC/VI initiation. This might have a relevant impact in clinical practice, especially in the setting of pulmonary rehabilitation. Nonetheless, further multicenter prospective studies are warranted to validate our findings and to identify predictors of treatment success.