A Comparative Study of Ambroxol and N-Acetylcysteine in Chronic Obstructive Pulmonary Disease Patients in a Tertiary Care Hospital, Kanpur (UP)

Main Article Content

Krishna Kumar Verma
Madhulika Peter Samuel
NilamNigam
Shweta Tripathi
KritiJalota

Keywords

COPD, Ambroxol, N-acetylcysteine, mucolytics, pulmonary function, sputum clearance

Abstract

Background: Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory disorder characterized by persistent airflow limitation, chronic inflammation, and mucus hypersecretion leading to impaired mucociliary clearance and frequent exacerbations. Mucoactive drugs such as Ambroxol and N-acetylcysteine (NAC) are commonly used as adjunct therapy to improve mucus clearance and reduce symptoms.


Objective: To compare the efficacy and safety of Ambroxol and N-acetylcysteine (NAC) in patients with stable COPD.


Methods: A prospective, randomized comparative interventional study was conducted in a tertiary care hospital in Kanpur. A total of 215 COPD patients were enrolled; after exclusions and dropouts, 200 patients completed the study. Patients were randomized into two groups: Group A received Ambroxol, and Group B received NAC for 14 days along with standard COPD therapy. Outcomes were evaluated using spirometry parameters (FEV₁, FVC), sputum score, mMRC dyspnea scale, Visual Analog Scale (VAS), health-related quality of life (HRQL), and adverse drug reactions.


Results: A total of 215 COPD patients were initially enrolled in the study. Both Ambroxol and NAC significantly improved pulmonary function, sputum clearance, and dyspnea scores over 14 days. However, Ambroxol demonstrated greater improvement in sputum clearance and symptom relief, while NAC showed comparable improvements in lung function. Both drugs exhibited good tolerability with minimal adverse effects.


Conclusion:Ambroxol and NAC are effective adjunct therapies in COPD management, with Ambroxol showing slightly superior symptomatic benefit. Both drugs are safe and improve patient outcomes.

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References

1.World Health Organization. Chronic obstructive pulmonary disease (COPD). Geneva: WHO; 2023. Available from: https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd)
2.Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management and Prevention of COPD – 2023 Report. GOLD; 2023.
3.Salvi S, Agrawal A. India needs a national COPD prevention and control programme. J Assoc Physicians India. 2012;60(Suppl):5–7.
4.Hogg JC, Timens W. The pathology of chronic obstructive pulmonary disease. Annu Rev Pathol.2009;4:435–459.
5.Vestbo J, Hurd SS, Agustí AG, Jones PW, Vogelmeier C, Anzueto A, et al. Global strategy for diagnosis, management and prevention of COPD. Am J Respir Crit Care Med. 2013;187(4):347–365.
6.Ma J, Rubin BK, Voynow JA. Mucins, mucus, and goblet cells. Chest. 2018;154(1):169–176.
7.Malerba M, Ragnoli B. Ambroxol in the management of respiratory diseases. MultidiscipRespir Med. 2008;3(4):224–229.
8.Cazzola M, Matera MG. Ambroxol in respiratory disease: pharmacological properties and clinical use. Respir Med. 2014;108(3):335–342.
9.Dekhuijzen PN. Antioxidant properties of N-acetylcysteine: relevance in relation to COPD. EurRespir J. 2004;23(4):629–636.
10.Zheng JP, Kang J, Huang SG, Chen P, Yao WZ, Yang L, et al. Effect of N-acetylcysteine on exacerbations of COPD (PANTHEON study). Lancet Respir Med. 2014;2(3):187–194.
11.Yan JH, Gao YS, Chen JH, Hu W. Mucoactive and antioxidant medicines for COPD: evidence review. Respir Care. 2017;62(3):350–358.
12.Poole P, Chong J, Cates CJ. Mucolytic agents versus placebo for chronic bronchitis or COPD. Cochrane Database Syst Rev. 2019;5:CD001287.
13.Bitou A, Elissalde S, Ozier A. Role of ambroxol in chronic respiratory diseases: narrative review. Respir Med Res.2021;79:100811.
14.Papi A, Vestbo J, Fabbri L, Corradi M, Prunier H, Cohuet G, et al. Extrafine inhaled triple therapy versus dual bronchodilator therapy in COPD. Lancet. 2018;391(10125):1076–1084.
15.Yan JH, Gao YS, Chen JH. Mucoactive therapy and lung function outcomes in COPD. Respir Care. 2017;62(3):350–358.
16.Poole P, Chong J, Cates CJ. Mucolytics for COPD: updated systematic review. Cochrane Database Syst Rev. 2019;5:CD001287.
17.Bitou A, Ozier A, Elissalde S. Clinical effectiveness of ambroxol in mucus clearance disorders. Respir Med Res.2021;79:100811.
18.Zheng JP, Kang J, Huang SG, Chen P, Yao WZ, Yang L, et al. High-dose N-acetylcysteine and exacerbation prevention in COPD. Lancet Respir Med. 2014;2(3):187–194.
19.Cazzola M, Matera MG. Pharmacological approaches to mucus hypersecretion in COPD. EurRespir Rev. 2014;23(134):504–513.