Chronic obstructive pulmonary disease (COPD) is a progressive disease characterized by persistent airflow limitation and chronic airway inflammation. The 2024 COPD clinical guidelines emphasize the central role of bronchodilators as the foundation of pharmacological treatment.
The aim of this review was to examine the evolution of therapeutic approaches to COPD management with a focus on the fixed-dose combination of indacaterol / glycopyrronium (IND/GLY).
Materials and Methods
An analysis of clinical studies evaluating the efficacy and safety of IND/GLY compared with monotherapy and other combination therapies was conducted. The synergistic mechanisms of long-acting β2-agonists (LABAs) and long-acting muscarinic antagonists (LAMAs), as well as the potential benefits of their combined use, are discussed. Special attention is paid to the impact of IND/GLY on lung function, exacerbation rates, quality of life, and its applicability across various clinical scenarios.
Results. The analysis confirmed significant clinical advantages of IND/GLY in patients with moderate to severe COPD. Results of an international, multicenter, randomized, open-label comparative study assessing the efficacy and safety of the generic combination glycopyrronium bromide + indacaterol (Respihale®; PSK Pharma, Russia) versus the original product Ultibro® Breezhaler® (Novartis Pharma AG, Switzerland) in patients with moderate COPD are presented.
Conclusion. IND/GLY represents a highly effective therapeutic option for patients with COPD, offering significant advantages over LABA or LAMA monotherapy and, in certain clinical settings, over LABA/ICS combinations. The first domestically produced dual bronchodilator containing glycopyrronium bromide and indacaterol has recently entered the market. Clinical equivalence studies confirmed non-inferior efficacy and comparable safety of the generic product in patients with moderate COPD.
Zaurbek R. Aisanov, MD, PhD, Professor
Professor, Department of Pulmonology, Faculty of Continuing Professional Education,
Pirogov Russian National Research Medical University, Ministry of Health of the Russian Federation
Denis Yu. Ilyushin
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