ISSN 2412-4036 (print)
ISSN 2713-1823 (online)

Clinical efficacy of erdosteine in chronic obstructive pulmonary disease: More than just a mucolytic

N.A. Karoli, G.R. Dolishnyaya

V.I. Razumovsky Saratov State Medical University, Saratov, Russian Federation
Abstract. Exacerbations of chronic obstructive pulmonary disease (COPD) lead to a rapid decline in lung function, health deterioration, hospitalization, and increased disease-related mortality. Use of mucoactive agents as a part of combination therapy can reduce the frequency of COPD exacerbations. This article systematizes published data on the safety and clinical efficacy of erdosteine as an additional remedy to standard COPD therapy. Erdosteine is an orally administered mucoactive drug with antioxidant and anti-inflammatory properties. Its use reduces the adhesion of pathogenic bacteria and increases the efficacy of antibacterial drugs. An important peculiarity of erdosteine is its potential use both as a preventative therapy for COPD exacerbations and as a modifier of exacerbation symptoms. During COPD exacerbations, adjunctive use of this drug is accompanied by rapid relief of clinical manifestations and a shortened acute phase of the disease. Long-term use of erdosteine in patients with COPD has demonstrated its superior efficacy and safety comparatively to other mucolytics, with a reduction in exacerbation frequency and an increase in the time to first exacerbation. These aspects are highly actual for the combination therapy of COPD patients in terms of the prevention of exacerbations and their treatment.

Keywords

chronic obstructive pulmonary disease
mucolytic therapy
erdosteine
exacerbation of chronic obstructive pulmonary disease

References

1. Клинические рекомендации. Хроническая обструктивная болезнь легких. Ассоциация врачей и специалистов медицины труда, Общероссийская общественная организация «Российское научное медицинское общество терапевтов», Российское респираторное общество. Рубрикатор клинических рекомендаций Минздрава России. 2024. ID: 603_3. Доступ: https://cr.minzdrav.gov.ru/view-cr/603_3 (дата обращения – 13.10.2025). (Clinical guidelines. Chronic obstructive pulmonary disease. Association of physicians and specialists in occupational medicine, Russian Scientific Medical Society of Internal Medicine, Russian Respiratory Society. Rubricator of clinical guidelines of the Ministry of Healthcare of Russia. 2024. ID: 603_3. URL: https://cr.minzdrav.gov.ru/view-cr/603_3 (date of access – 13.10.2025) (In Russ.)).

2. Papi A, Avdeev S, Calverley PMA, Cordeiro CR, Jesenak M, Koblízek V et al. Use of mucolytics in COPD: A Delphi consensus study. Respir Med. 2020;106190.

PMID: 33217537. https://doi.org/10.1016/j.rmed.2020.106190

3. Shen Y, Huang S, Kang J, Lin J, Lai K, Sun Y et al. Management of airway mucus hypersecretion in chronic airway inflammatory disease: Chinese expert consensus (English edition). Int J Chron Obstruct Pulmon Dis. 2018;13:399–407.

PMID: 29430174. PMCID: PMC5796802. https://doi.org/10.2147/COPD.S144312

4. Yan X, Song Y, Shen C, Xu W, Chen L, Zhang J et al. Mucoactive and antioxidant medicines for COPD: Consensus of a group of Chinese pulmonary physicians. Int J Chron Obstruct Pulmon Dis. 2017;12:803–12.

PMID: 28405161. PMCID: PMC5378456. https://doi.org/10.2147/COPD.S114423

5. Hill DB, Button B, Rubinstein M, Boucher RC. Physiology and pathophysiology of human airway mucus. Physiol Rev. 2022;102(4):1757–836.

PMID: 35001665. PMCID: PMC9665957. https://doi.org/10.1152/physrev.00004.2021

6. Radicioni G, Ceppe A, Ford AA, Alexis NE, Barr RG, Bleecker ER et al. Airway mucin MUC5AC and MUC5B concentrations and the initiation and progression of chronic obstructive pulmonary disease: An analysis of the SPIROMICS cohort. Lancet Respir Med. 2021;9(11):1241–54.

PMID: 34058148. PMCID: PMC8570975. https://doi.org/10.1016/S2213-2600(21)00079-5

7. Kardos P. Mucus: An underestimated player in airway diseases. Lung. 2025;203(1):60.

PMID: 40327143. https://doi.org/10.1007/s00408-025-00816-4

8. Dunican EM, Elicker BM, Henry T, Gierada DS, Schiebler ML, Anderson W et al. Mucus plugs and emphysema in the pathophysiology of airflow obstruction and hypoxemia in smokers. Am J Respir Crit Care Med. 2021;203(8):957–68.

PMID: 33180550. PMCID: PMC8048745. https://doi.org/10.1164/rccm.202006-2248OC

9. Chassagnon G, Burgel PR. Mucus plugs in medium-sized airways: A novel imaging biomarker for phenotyping chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2021;203(8):932–34.

PMID: 33264069. PMCID: PMC8048760. https://doi.org/10.1164/rccm.202011-4178ED

10. Charriot J, Volpato M, Petit A, Vachier I, Bourdin A. Methods of sputum and mucus assessment for muco-obstructive lung diseases in 2022: time to “unplug” from our daily routine! Cells. 2022;11(5):812.

PMID: 35269434. PMCID: PMC8909676. https://doi.org/10.3390/cells11050812

11. Pangeni R, Meng T, Poudel S, Sharma Divya, Hutsell H, Ma J et al. Airway mucus in pulmonary diseases: Muco-adhesive and muco-penetrating particles to overcome the airway mucus barriers. Int J Pharm. 2023;634:122661.

PMID: 36736964. PMCID: PMC9975059. https://doi.org/10.1016/j.ijpharm.2023.122661

12. Boucher RC. Muco-obstructive lung diseases. N Engl J Med. 2019;380(20):1941–53.

PMID: 31091375. https://doi.org/10.1056/NEJMra1813799

13. Singh G, Acharya S, Shukla S, Jain D. Muco-obstructive lung disease: A systematic review. Cureus. 2023;15(10):e46866.

PMID: 37954759. PMCID: PMC10637992. https://doi.org/10.7759/cureus.46866

14. Balsamo R, Lanata L, Egan CG. Mucoactive drugs. Eur Respir Rev. 2010;19(116):127–33.

PMID: 20956181. PMCID: PMC9682576. https://doi.org/10.1183/09059180.00003510

15. Aaron SD. Mucolytics for COPD: Negotiating a slippery slope towards proof of efficacy. Eur Respir J. 2017;50(4):1701465.

PMID: 29025882. https://doi.org/10.1183/13993003.01465-2017

16. Zatloukal J, Page C, Brat K, Svoboda M, Volaková E, Plutinsky M et al. Effect of treatment with mucoactive drugs on COPD exacerbations during 5 years of follow-up in the Czech Republic: A real-world study. Lung. 2025;203(1):61.

PMID: 40327168. PMCID: PMC12055937. https://doi.org/10.1007/s00408-025-00813-7

17. Poole P, Sathananthan K, Fortescue R. Mucolytic agents versus placebo for chronic bronchitis or chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2019;2019(5):CD001287.

PMID: 31107966. PMCID: PMC6527426. https://doi.org/10.1002/14651858.CD001287.pub6

18. Ohnishi H, Tanimoto T, Inaba R, Eitoku M. Efficacy and safety of mucolytics in patients with stable chronic obstructive pulmonary disease: A systematic review and meta-analysis. Respiratory Investig. 2024;62(6):1168–75.

PMID: 39413571. https://doi.org/10.1016/j.resinv.2024.10.004

19. Cazzola M, Rogliani P, Calzetta L, Hanania NA, Matera MG. Impact of mucolytic agents on COPD exacerbations: A pair-wise and network meta-analysis. COPD. 2017;14(5):552–63.

PMID: 28753070. https://doi.org/10.1080/15412555.2017.1347918

20. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Published online 2026. URL: http://www.goldcopd.org/ (date of access – 13.10.2025).

21. Dobler CC, Morrow AS, Farah MH, Beuschel B, Majzoub AM, Wilson ME et al. Pharmacologic and nonpharmacologic therapies in adult patients with exacerbation of COPD: A systematic review (Internet). Rockville (MD): Agency for Healthcare Research and Quality (US). 2019. Report No.: 19(20)-EHC024-EF. PMID: 31657888.

22. Cazzola M, Calzetta L, Page C, Rogliani P, Matera MG. Impact of erdosteine on chronic bronchitis and COPD: A meta-analysis. Pulm Pharmacol Ther. 2018;48:185–94.

PMID: 29233650. https://doi.org/10.1016/j.pupt.2017.11.009

23. Dal Negro RW, Visconti M, Micheletto C, Tognella S. Changes in blood ROS, e-NO, and some pro-inflammatory mediators in bronchial secretions following erdosteine or placebo: A controlled study in current smokers with mild COPD. Pulm Pharmacol Ther. 2008;21(2):304–8.

PMID: 17889580. https://doi.org/10.1016/j.pupt.2007.07.004

24. Авдеев С.Н., Трушенко Н.В., Чикина С.Ю., Суворова О.А. Возможности терапии эрдостеином в снижении частоты обострений хронической обструктивной болезни легких. Пульмонология. 2022;32(2):253–259. (Avdeev SN, Trushenko NV, Chikina SYu, Suvorova OA. The potential of erdosteine to reduce the rate of exacerbations of chronic obstructive pulmonary disease. Pulmonologiya = Pulmonology. 2022;32(2):253–259 (In Russ.)).

EDN: HCIYYT. https://doi.org/10.18093/0869-0189-2022-32-2-253-259

25. Ricevuti G, Mazzone A, Uccelli E, Gazzani G, Fregnan GB. Influence of erdosteine, a mucolytic agent, on amoxycillin penetration into sputum in patients with an infective exacerbation of chronic bronchitis. Thorax. 1988;43(8):585–90.

PMID: 3051508. PMCID: PMC461392. https://doi.org/10.1136/thx.43.8.585

26. Cazzola M, Page C, Rogliani P, Calzetta L, Matera MG. Multifaceted beneficial effects of erdosteine: More than a mucolytic agent. Drugs. 2020;80(17):1799–809.

PMID: 33025535. PMCID: PMC7647991. https://doi.org/10.1007/s40265-020-01412-x

27. Santus P, Strizzi S, Danzo F, Biasin M, Saulle I, Vanetti C et al. Antiviral effect of erdosteine in cells infected with human respiratory viruses. Pathogens. 2025;14(4):388.

PMID: 40333155. PMCID: PMC12030430. https://doi.org/10.3390/pathogens14040388

28. Moretti M, Bottrighi P, Dallari R, Da Porto R, Dolcetti A, Grandi P et al.; EQUALIFE Study Group The effect of long-term treatment with erdosteine on chronic obstructive pulmonary disease: The EQUALIFE Study. Drugs Exp Clin Res. 2004;30(4):143–52. PMID: 15553660.

29. Dal Negro RW, Wedzicha JA, Iversen M, Fontana G, Page C, Ciceroet AF al. Effect of erdosteine on the rate and duration of COPD exacerbations: The RESTORE study. Eur Respir J. 2017;50(4):1700711.

PMID: 29025888. PMCID: PMC5678897. https://doi.org/10.1183/13993003.00711-2017

30. Calverley PM, Page C, Dal Negro RW, Fontana G, Cazzola M, Cicero AF et al. Effect of erdosteine on COPD exacerbations in COPD patients with moderate airflow limitation. Int J Chron Obstruct Pulmon Dis. 2019;14:2733–44.

PMID: 31819405. PMCID: PMC6896911. https://doi.org/10.2147/COPD.S221852

31. Calverley PMA, Papi A, Page C, Rogliani P, Dal Negro RW, Cazzola M et al. The effect of maintenance treatment with erdosteine on exacerbation treatment and health status in patients with COPD: A post-hoc analysis of the RESTORE dataset. Int J Chron Obstruct Pulmon Dis. 2022;17:1909–20.

PMID: 36034589. PMCID: PMC9416404. https://doi.org/10.2147/COPD.S369804. Erratum in: Int J Chron Obstruct Pulmon Dis. 2022;17:2451–52. PMID: 36034589. PMCID: PMC9416404. https://doi.org/10.2147/COPD.S391851

32. Rogliani P, Matera MG, Page C, Puxeddu E, Cazzola M, Calzetta L. Efficacy and safety profile of mucolytic/antioxidant agents in chronic obstructive pulmonary disease: A comparative analysis across erdosteine, carbocysteine, and N-acetylcysteine. Respir Res. 2019;20(1):104.

PMID: 31133026. PMCID: PMC6537173. https://doi.org/10.1186/s12931-019-1078-y

33. Будневский АВ, Овсянников ЕС, Перцев АВ, Кожевникова СА. Клиническая эффективность вакцинации, эрдостеина и легочной реабилитации в профилактике обострений хронической обструктивной болезни легких. Туберкулез и болезни легких. 2016;94(11):44–49. (Budnevskiy AV, Ovsyannikov ES, Pertsev AV, Kozhevnikova SA. Clinical efficiency of vaccination, erdosteine and pulmonary rehabilitation in the prevention of chronic obstructive pulmonary disease exacerbations. Tuberkulez i bolezni legkikh = Tuberculosis and Lung Diseases. 2016;94(11):44–49 (In Russ.)). EDN: XELNCB.

34. Cazzola M, Calzetta L, Page C, Rogliani P, Matera MG. Thiol-based drugs in pulmonary medicine: Much more than mucolytics. Trends Pharmacol Sci. 2019;40(7):452–63.

PMID: 31147200. https://doi.org/10.1016/j.tips.2019.04.015

35. Трофименко ИН, Авдеев СН, Айсанов ЗР, Зайцев АА. Эрдостеин в лечении острых и хронических заболеваний дыхательной системы: резолюция научного форума экспертов «В центре внимания». Пульмонология. 2024;34(5):734–745 (Trofimenko IN, Avdeev SN, Aisanov ZR, Zaicev AA. Erdosteine in the treatment of acute and chronic diseases of the respiratory system: Resolution of the scientific forum of experts “In the Spotlight”. Pulmonologiya = Pulmonology. 2024;34(5):734–745 (In Russ.)).

EDN: EDKSZD. https://doi.org/10.18093/0869-0189-2024-34-5-734-745

36. Wedzicha JA, Calverley PMA, Albert RK, Anzueto A, Criner GJ, Hurst JR et al. Prevention of COPD exacerbations: A European Respiratory Society/American Thoracic Society guideline. Eur Respir J. 2017;50(3):1602265.

PMID: 28889106. https://doi.org/10.1183/13993003.02265-2016

37. Decramer M, Rutten-van Mölken M, Dekhuijzen PNR, Troosters T, Cees van Herwaarden, Pellegrino R et al. Effects of N-acetylcysteine on outcomes in chronic obstructive pulmonary disease (Bronchitis Randomized on NAC Cost-Utility Study, BRONCUS): A randomised placebo-controlled trial. Lancet. 2005;365(9470):1552–60.

PMID: 15866309. https://doi.org/10.1016/S0140-6736(05)66456-2. Erratum in: Lancet. 2005;366(9490):984.

38. Zheng JP, Wen FQ, Bai CX, Wan HY, Kang J, Chen P et al. Twice daily N-acetylcysteine 600 mg for exacerbations of chronic obstructive pulmonary disease (PANTHEON): A randomised, double-blind placebo-controlled trial. Lancet Respir Med. 2014;2(3):187–94.

PMID: 24621680. https://doi.org/10.1016/S2213-2600(13)70286-8

39. Zheng JP, Kang J, Huang SG, Chen P, Yao WZ, Yang L et al. Effect of carbocisteine on acute exacerbation of chronic obstructive pulmonary disease (PEACE Study): A randomised placebo-controlled study. Lancet. 2008;371(9629):2013–18.

PMID: 18555912. https://doi.org/10.1016/S0140-6736(08)60869-7

40. Papi A, Zheng J, Criner GJ, Fabbri LM, Calverley PMA. Impact of smoking status and concomitant medications on the effect of high-dose N-acetylcysteine on chronic obstructive pulmonary disease exacerbations: A post-hoc analysis of the PANTHEON study. Respir Med. 2019;147:37–43.

PMID: 30704697. https://doi.org/10.1016/j.rmed.2018.12.014

41. Welte T, Vogelmeier C, Papi A. COPD: Early diagnosis and treatment to slow disease progression. Int J Clin Pract. 2015;69(3):336–49.

PMID: 25363328. https://doi.org/10.1111/ijcp.12522

42. Moretti M. Pharmacology and clinical efficacy of erdosteine in chronic obstructive pulmonary disease. Expert Rev Respir Med. 2007;1(3):307–16.

PMID: 20477170. https://doi.org/10.1586/17476348.1.3.307

43. Imamura Y, Kawayama T, Kinoshita T, Sakazaki Y, Yoshida M, Takahashi K et al. Poor pharmacological adherence to inhaled medicines compared with oral medicines in Japanese patients with asthma and chronic obstructive pulmonary disease. Allergol Int. 2017;66(3):482–84.

PMID: 27887878. https://doi.org/10.1016/j.alit.2016.10.008

44. Papadopoulou E, Hansel J, Lazar Z, Kostikas K, Tryfon S, Vestbo J et al. Mucolytics for acute exacerbations of chronic obstructive pulmonary disease: A meta-analysis. Eur Respir Rev. 2023;32(167):220141.

PMID: 36697209. PMCID: PMC9879332. https://doi.org/10.1183/16000617.0141-2022

45. Moretti M, Fagnani S. Erdosteine reduces inflammation and time to first exacerbation postdischarge in hospitalized patients with AECOPD. Int J Chron Obstruct Pulmon Dis. 2015;10:2319–25.

PMID: 26604731. PMCID: PMC4630194. https://doi.org/10.2147/COPD.S87091

46. Marchioni CF, Polu JM, Taytard A, Hanard T, Noseda G, Mancini C. Evaluation of efficacy and safety of erdosteine in patients affected by chronic bronchitis during an infective exacerbation phase and receiving amoxycillin as basic treatment (ECOBES, European Chronic Obstructive Bronchitis Erdosteine Study). Int J Clin Pharmacol Ther. 1995;33(11):612–18. PMID: 8688986.

47. Cazzola M, Floriani I, Page CP. The therapeutic efficacy of erdosteine in the treatment of chronic obstructive bronchitis: A meta-analysis of individual patient data. Pulm Pharmacol Ther. 2010;23(2):135–44.

PMID: 19854285. https://doi.org/10.1016/j.pupt.2009.10.002

48. Mohanty KC, Thiappanna G, Singh V, Mancini C. Evaluation of efficacy and safety of erdosteine in patients affected by exacerbation of chronic bronchitis and receiving ciprofloxacin as basic treatment. J Clin Research. 2001;4(35):35–39.

About the Authors

Nina A. Karoli, MD, Dr. Sci. (Medicine), professor of the Department of hospital therapy, V.I. Razumovsky Saratov State Medical University, Saratov, Russian Federation.
E-mail: nina.karoli.73@gmail.com
ORCID: https://orcid.org/0000-0002-7464-826X. Scopus ID: 6603194518. eLibrary SPIN: 6506-0261
Gulnara R. Dolishnyaya, MD, PhD (Medicine), associate professor of the Department of hospital therapy, V.I. Razumovsky Saratov State Medical University, Saratov, Russian Federation.
E-mail: dolishnyayagulnara@gmail.com
ORCID: https://orcid.org/0000-0001-6327-1703. Scopus ID: 55934883400. eLibrary SPIN: 1232-0138

Similar Articles