Clinical and patient-reported outcomes of triple therapy (budesonide/glycopyrronium bromide/formoterol) in chronic obstructive pulmonary disease: results of the observational MINERVA study

Objective. The evaluation of clinical and patient-reported outcomes in patients with chronic obstructive pulmonary disease (COPD) treated with the triple combination of budesonide/glycopyrronium bromide/formoterol (BUD/GLY/FORM) in real-life clinical practice. Material and methods. The non-interventional MINERVA study (NCT06422676) was conducted in Russia in 2023—2024. Retrospective data were collected for a period of 12 months before the start of therapy. The prospective observation period was 24 weeks from the start of therapy. Results. The study included 200 patients, average age 64.97 years, 58.5% of patients ≥65 years and older, 87.5% of patients were male, 59% were active smokers. The average baseline CAT (COPD Assessment Test) score was 23.80. A total of 137 (68.5%) patients had moderate or severe COPD exacerbations in the previous 12 months. A total of 196 patients completed 24 weeks of treatment. The mean (95% confidence interval (CI)) change in CAR score from baseline was –8.81 (–9.85; –7.76) at week 24 and –5.63 (–6.29; –4.98) at week 12. In patients with severe exacerbations in the past year, it was –11.57 (–14.08; –9.07) and –6.22 (–7.69; –4.76), respectively; in patients with elevated baseline blood eosinophil levels, the change was –9.21 (–12.25; –6.17) and –6.21 (–8.41; –4.01), respectively. A reduction in CAT by ≥2 points by week 24 was achieved in 87% of patients (95% CI 81.53%; 91.33%). The average number of moderate exacerbations per patient decreased from 0.83 to 0.03, severe exacerbations — from 0.44 to 0.02. The therapy was characterized by high compliance, was safe and well tolerated. Conclusion. The use of BUD/GLI/FORM leads to an improvement in the condition of patients with COPD and can significantly reduce the frequency of exacerbations.