Real-life therapeutic effects of beclomethasone dipropionate/formoterol fumarate/glycopyrronium combined triple therapy in patients with chronic obstructive pulmonary disease

Abstract

Background: The small airway disease has been recognized as a central feature of chronic obstructive pulmonary disease (COPD). Triple fixed combination beclomethasone dipropionate/formoterol fumarate/glycopyrronium (BDP/FF/G) is provided as a pressurized single-dose inhaler based on an extra-fine formulation, which has been approved for patients with COPD experiencing frequent disease exacerbations. Methods: The aim of our real-life single-center observational study was to investigate, in 22 patients with COPD, the effects of BDP/FF/G on lung function, respiratory symptoms, health status, and exacerbation rate. Several clinical and lung functional parameters were evaluated at baseline and after 12 months of treatment with combined inhaled triple therapy. Results: With respect to baseline, after 12 months of treatment with BDP/FF/G, significant changes were recorded with regard to forced expiratory flow at 75% of forced vital capacity (FVC) ( p < 0.01), forced expiratory flow at 50% of FVC ( p < 0.01), forced expiratory flow at 25% of FVC ( p < 0.05), and forced mid-expiratory flow between 25% and 75% of FVC ( p < 0.01). Moreover, we observed reductions of total resistance ( p < 0.01), effective resistance ( p < 0.01), and effective specific resistance ( p < 0.01). In the same period, residual volume diminished ( p < 0.01) and forced expiratory volume in 1 s increased ( p < 0.01). Moreover, in a subgroup of 16 patients, an enhancement of diffusion lung capacity ( p < 0.01) was also detected. These functional results were paralleled by concomitant clinical effects, as evidenced by the improvements of modified British Medical Research Council (mMRC) dyspnea scale ( p < 0.001), COPD Assessment Test (CAT) score ( p < 0.0001), and COPD exacerbations ( p < 0.0001). Conclusion: In conclusion, the valuable findings of our observational study consist in the corroboration in a real-life context of the therapeutic effects evidenced by randomized controlled trials with regard to the use of the triple inhaled BDP/FF/G therapy in patients with COPD.