Currently, chronic obstructive pulmonary disease (COPD) is a global health issue and one of the leading causes of death in the world. COPD therapy includes pharmacological and non-pharmacological approaches that can significantly improve clinical symptoms and reduce frequency of exacerbations of the disease.Methodology. The target audience of these clinical recommendations are therapists, general practitioners, and pulmonologists. Each thesis-recommendation about diagnostic and therapeutic procedures was graded according to the scales of classes of recommendations from 1 to 5 and the A, B, C scale of the levels of evidence. The clinical recommendations also contain comments and explanations to the theses together with algorithms for the diagnosis and treatment of COPD.Conclusion. The presented clinical guidelines cover the latest information about the etiology and pathogenesis, clinical manifestations, diagnosis, treatment, and prevention of chronic obstructive pulmonary disease. These guidelines were approved by the Scientific and Practical Council of the Ministry of Health of the Russian Federation in 2021.

РОССИЙСКОЕ РЕСПИРАТОРНОЕ ОБЩЕСТВО. ФЕДЕРАЛЬНЫЕ КЛИНИЧЕСКИЕ РЕКОМЕНДАЦИИ ПО ДИАГНОСТИКЕ И ЛЕЧЕНИЮ ХРОНИЧЕСКОЙ ОБСТРУКТИВНОЙ БОЛЕЗНИ ЛЕГКИХ

Treatment of patients with chronic obstructive pulmonary disease (COPD) is one of the most important tasks of clinical medicine due to high prevalence of and high mortality from COPD. Treatment of COPD as a heterogeneous disease requires different approaches depending on the severity and the clinical course of COPD. Clinical guidelines have become the principal document that regulates different aspects of management of COPD patients. Algorithms of management and clinical decision making are the crucial part of guidelines because they help achieving a balance between making the decision in different clinical situations and simple graphics. The simplified approach is important for implementation the algorithm into clinical practice. Different evidence-based therapeutic schemes proposed by experts of Russian Respiratory Society and other countries have been enclosed into this article with discussion about their strengths and limitations and possibility of practical use. The Russian algorithm reflects a current view on differentiated management of COPD patients and fits the requirements of Healthcare Ministry of Russian Federation and needs of achieving the optimal balance between high informative significance and a simple graphics of the scheme.

Asthma is a heterogeneous and complex disease in both its clinical course and response to treatment. IL-13 is central to Type 2 inflammation and contributes to many features of asthma. In a previous Phase 2 study, lebrikizumab, an anti-IL-13 monoclonal antibody, did not significantly improve FEV1 in mild-to-moderate asthma patients not receiving ICS therapy. This Phase 3 study was designed to further assess the efficacy and safety of lebrikizumab in adult patients with mild-to-moderate asthma treated with daily short-acting β2-agonist therapy alone. Adult patients with mild-to-moderate asthma were randomised to receive lebrikizumab 125 mg subcutaneously (SC), placebo SC, or montelukast 10 mg orally for 12 weeks, with an 8-week follow-up period. The primary efficacy endpoint was absolute change in pre-bronchodilator FEV1 from baseline at Week 12. A total of 310 patients were randomised and dosed in the study. The mean absolute change in FEV1 from baseline at Week 12 was higher in the lebrikizumab-treated arm compared with placebo (150 mL versus 67 mL); however, this improvement did not achieve statistical significance (overall adjusted difference of 83 mL [95% CI: -3, 170]; p = .06). Montelukast did not improve FEV1 as compared with placebo. Lebrikizumab was generally safe and well tolerated during the study. Lebrikizumab did not significantly improve FEV1 in mild-to-moderate asthma patients at a dose expected to inhibit the IL-13 pathway. Inhibiting IL-13 in this patient population was not sufficient to improve lung function. These data support the findings of a previous trial of lebrikizumab in patients not receiving ICS. This trial was registered under NCT02104674 at http://www.clinicaltrials.gov.

The high prevalence of COPD together with its high level of misdiagnosis and late diagnosis dictate the necessity for the development and implementation of clinical practice guidelines (CPGs) in order to improve the management of this disease. High-quality, evidence-based international CPGs need to be adapted to the particular situation of each country or region. A new version of the Russian Respiratory Society guidelines released at the end of 2016 was based on the proposal by Global Initiative for Obstructive Lung Disease but adapted to the characteristics of the Russian health system and included an algorithm of pharmacologic treatment of COPD. The proposed algorithm had to comply with the requirements of the Russian Ministry of Health to be included into the unified electronic rubricator, which required a balance between the level of information and the simplicity of the graphic design. This was achieved by: exclusion of the initial diagnostic process, grouping together the common pharmacologic and nonpharmacologic measures for all patients, and the decision not to use the letters A–D for simplicity and clarity. At all stages of the treatment algorithm, efficacy and safety have to be carefully assessed. Escalation and de-escalation is possible in the case of lack of or insufficient efficacy or safety issues. Bronchodilators should not be discontinued except in the case of significant side effects. At the same time, inhaled corticosteroid (ICS) withdrawal is not represented in the algorithm, because it was agreed that there is insufficient evidence to establish clear criteria for ICSs discontinuation. Finally, based on the Global Initiative for Obstructive Lung Disease statement, the proposed algorithm reflects and summarizes different approaches to the pharmacological treatment of COPD taking into account the reality of health care in the Russian Federation.