Fixed-dose bronchodilator combinations in chronic obstructive pulmonary disease: focus on indacaterol/ glycopyrronium

Chronic obstructive pulmonary disease (COPD) is a progressive disease involving persistent airflow limitation and a chronic inflammatory response of the airways. Recent clinical guidelines emphasize the importance of bronchodilators as the primary pharmacological treatment for COPD. The aim this review was to examine the evolution of therapeutic approaches to COPD treatment, focusing particularly on the fixed-dose combination of indacaterol and glycopyrronium (FCIG). Methods. Clinical trials evaluating the efficacy and safety of FCIG compared to monotherapy and other combination drugs were analyzed. The review discusses the synergistic mechanisms of long-acting beta-2 agonists (LABA) and long-acting anticholinergic drugs (LAMA), as well as the potential benefits of their simultaneous use. The review pays special attention to the effect of the fixeddose combination on lung functional parameters, exacerbation frequency, and patients’ quality of life, as well as its application in different clinical situations. Results. The results of the analysis indicate significant clinical advantages of a fixed combination of FCIG in the treatment of patients with COPD of moderate to severe severity of bronchial obstruction. Results from an international, multicenter, randomized, open-label, comparative clinical trial evaluating the efficacy and safety of the generic combination of glycopyrronium bromide and indacaterol – drug Respihale® (PSK Pharma LLC, Russia) versus the branded drug Ultibro® Breezhaler® (Novartis Pharma AG, Switzerland) in patients with moderate COPD are also presented. Conclusion. The fixed-dose indacaterol-glycopyrronium combination is a highly effective therapeutic option for patients with COPD, providing significant advantages over LAMA or LABA monotherapy, and in some clinical situations, compared with the LABA/ICS combination. To date, the first domestic dual bronchodilator containing glycopyrronium bromide and indacaterol has appeared on the market – the drug Respihale® (PSK Pharma LLC, Russia). The conducted clinical equivalence study confirmed non-inferiority and comparable safety of the reproduced drug in patients with moderate COPD.