Impact of umeclidinium/vilanterol dual bronchodilator therapy on pulmonary function and inflammatory responses in...

Chronic obstructive pulmonary disease (COPD) represents a significant global health burden necessitating optimized therapeutic interventions. Contemporary guidelines advocate for individualized bronchodilator therapy, yet comparative real-world effectiveness data remain limited, particularly in Chinese populations. To evaluate the comparative effectiveness and safety of umeclidinium/vilanterol (UMEC/VI) dual bronchodilator therapy versus tiotropium monotherapy and budesonide/formoterol combination in patients with stable COPD over a 12-month observation period. This prospective observational cohort study enrolled 171 patients with stable COPD from February 2020 to February 2022 at a tertiary respiratory center. Participants were allocated to treatment groups based on clinical discretion following GOLD guidelines: UMEC/VI (n = 57), tiotropium (n = 57), or budesonide/formoterol (n = 57). The primary outcome was change in forced expiratory volume in one second (FEV₁) from baseline to 12 months. Secondary outcomes included functional capacity, symptom burden, inflammatory biomarkers, exacerbation rates, and adverse events. Statistical analysis employed multivariable mixed-effects models with propensity score adjustment to control for confounding. All treatment groups demonstrated significant improvements from baseline, with UMEC/VI showing superior outcomes. The adjusted mean change in FEV₁ was 12.6% (95% CI: 9.2-15.9%) for UMEC/VI versus 8.1% (95% CI: 5.4-10.8%) for tiotropium and 5.3% (95% CI: 2.8-7.8%) for budesonide/formoterol (p < 0.001). UMEC/VI was associated with greater improvements in exercise tolerance (6-minute walking distance: +4 5.7 m, 95% CI: 32.5-58.9 m), symptom control (CAT score reduction: - 4.2 points, 95% CI: -5.1 to -3.3), and inflammatory markers. Exacerbation rates were lowest with UMEC/VI (0.42 vs. 0.61 vs. 0.89 events per patient-year, respectively). Adverse event incidence was significantly lower in the UMEC/VI group (8.8%, 95% CI: 3.7-19.6%) compared to budesonide/formoterol (29.8%, 95% CI: 19.2-42.9%). This observational study suggests that UMEC/VI dual bronchodilator therapy is associated with superior clinical outcomes and a favorable safety profile in patients with stable moderate COPD. However, these findings require validation through adequately powered randomized controlled trials before definitive therapeutic recommendations can be established.