Impact of Single-Inhaler Triple Therapy FF/UMEC/VI on Disease Stability in COPD: A Real-World 12-Month Analysis

Single-inhaler triple therapy with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) is recommended for patients with chronic obstructive pulmonary disease (COPD) who remain symptomatic or experience exacerbations despite dual bronchodilation. However, real-world evidence on its ability to achieve multidimensional "disease stability", integrating symptoms, lung function, and exacerbation outcomes, remains limited. The aim of our study was therefore to evaluate, in a real-world cohort of exacerbating patients with COPD, the effects of once-daily FF/UMEC/VI on lung function, respiratory symptoms, health status, and exacerbation rates over 12 months.

This retrospective single-center study included 86 adults with COPD treated with FF/UMEC/VI 92/55/22 µg at the Respiratory Unit of "Magna Graecia" University Hospital (Catanzaro, Italy). Lung function tests (forced expiratory volume in the first second, FEV₁; forced vital capacity, FVC; forced mid-expiratory flow between 25% and 75% of FVC, FEF_25-75; residual volume, RV; total lung capacity, TLC; corrected single-breath diffusion lung capacity for carbon monoxide, DLCOcSB) were performed at baseline and after 12 months. Symptoms and health status were assessed using the COPD Assessment Test (CAT). Moderate and severe exacerbations were recorded within the previous 12 months and 12 months after treatment initiation. Safety and tolerability were monitored via monthly phone follow-up.

Eighty-six patients were included (24 women, 28%; 62 men, 72%), with a mean age of 72.29 ± 9.20 years and a median BMI of 30 (26.00-36.50) kg/m². After 12 months of FF/UMEC/VI, lung function significantly improved: FEV₁ increased from 1.46 ± 0.51 l to 1.61 ± 0.60 l (p < 0.01), FEV₁/FVC from 0.65 ± 0.11 to 0.69 ± 0.11 (p < 0.001), and FEF_25-75 from 0.84 (0.54-1.15) l/s to 0.99 (0.71-1.53) l/s (p < 0.001). Pulmonary hyperinflation decreased, with RV declining from 2.90 (2.25-3.80) l to 2.50 (1.72-3.20) l (p < 0.0001). DLCOcSB increased from 4.59 ± 1.36 to 4.86 ± 1.53 mmol/min/kPa (p < 0.05). CAT score improved from 25.99 ± 4.03 to 22.93 ± 5.76 (p < 0.0001). The number of moderate/severe exacerbations decreased from 2.08 ± 0.66 to 0.15 ± 0.36, and 63 patients (73%) met the composite criteria for COPD disease stability.

In this real-world cohort of exacerbating patients with COPD, once-daily single-inhaler FF/UMEC/VI was associated with improved lung function, reduced hyperinflation, better symptom control, enhanced quality of life, and a significant reduction in exacerbation frequency. These findings suggest that FF/UMEC/VI may be a useful therapeutic option for supporting multidimensional disease stability in high-risk patients with COPD, although prospective controlled studies are needed to confirm these observations.