BDP/FF/GB single-inhaler triple therapy in COPD: real-world effectiveness, safety, and adherence in a pooled analysis of 5,000 patients.

BACKGROUND

Chronic Obstructive Pulmonary Disease (COPD) represents a major global health challenge, frequently necessitating triple therapy for patients unresponsive to dual bronchodilation. Single-inhaler triple therapy (SITT) combining beclomethasone dipropionate/formoterol fumarate/glycopyrronium bromide (BDP/FF/GB) offers a practical and effective solution with potential adherence benefits in real-world settings.

METHODS

This pooled analysis included patient-level data from six European prospective observational studies assessing the real-world effectiveness and safety of BDP/FF/GB SITT in COPD patients over 6 months. Outcomes included changes in health-related quality of life (HRQoL; measured by COPD Assessment Test [CAT] scores), lung function (FEV1), and adherence, with safety and exacerbation rates assessed through 12 months. Subgroup comparisons based on prior therapy, exacerbation history, and disease severity were also performed.

RESULTS

Among 5523 patients enrolled, 4541 were included in the full analysis set. Significant improvements in HRQoL were observed, with mean CAT score reductions of -3.8 and -4.7 at months 3 and 6, respectively (p < 0.0001). Patients with at least one exacerbation decreased from 93.1% (pre-treatment) to 35.7% at 12 months (p < 0.0001). FEV1 improvements were observed up to 6 months, with over 40% of patients achieving ≥100 mL increase. Adherence significantly improved, with poor-adherence patients transitioning to higher categories over time. Logistic regression identified poor baseline adherence (vs. good), ex-smokers (vs non-smokers), and experiencing two (vs. >2) exacerbations as predictors of treatment response. Adverse events were reported by 21.9% of patients.

CONCLUSION

Extrafine BDP/FF/GB SITT demonstrated significant real-world safety and effectiveness in improving symptoms, lung function, and adherence.