Effect of carbocysteine on exacerbations and lung function in patients with mild-to-moderate chronic obstructive pulmonary disease: a multicentre, double-blind, randomised, placebo-controlled trial

Zhou, Yumin; Wu, Fan; Li, Haiqing; Deng, Zhishan; Lin, Li; Huang, Hong; Zhao, Haiyan; Wang, Yiran; Wang, Lingwei; Chen, Qijian; Cai, Shan; He, Zhiyi; Ying, Yinghua; Huang, Peiyu; Tian, Heshen; Peng, Jieqi; Xiao, Shan; Wen, Xiang; Yang, Huajing; Zhen, Youlan; Wang, Zihui; Zhao, Ningning; Lu, Lifei; Xu, Jianwu; Wang, Qiuyue; Ran, Pixin

doi:10.1016/j.arbres.2025.01.004

Archivos de Bronconeumología

ISSN: 0300-2896

Archivos de Bronconeumologia is an international journal that publishes original studies whose content is based upon results of research initiatives dealing with several aspects of respiratory medicine including epidemiology, respiratory physiology, pathophysiology of respiratory diseases, clinical management, thoracic surgery, pediatric lung diseases, respiratory critical care, respiratory allergy and translational research. Other types of articles such as editorials, reviews, and different types of letters are also published in the journal. Additionally, the journal expresses the voice of the following scientific societies: the Spanish Respiratory Society of Pneumology and Thoracic Surgery (SEPAR; https://www.separ.es/), the Latin American Thoracic Society (ALAT; https://alatorax.org/), and the Iberian American Association of Thoracic Surgery (AIACT; http://www.aiatorax.com/).

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Article types: Original articles

DOI: 10.1016/j.arbres.2025.01.004

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Pre-proof, online 7 January 2025

Effect of carbocysteine on exacerbations and lung function in patients with mild-to-moderate chronic obstructive pulmonary disease: a multicentre, double-blind, randomised, placebo-controlled trial

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Yumin Zhou1,2,#, Fan Wu1,#, Haiqing Li1,#, Zhishan Deng1,#, Li Lin3,#, Hong Huang4,#, Haiyan Zhao5,#, Yiran Wang6,#, Lingwei Wang7,#, Qijian Chen8,#, Shan Cai9,#, Zhiyi He10, Yinghua Ying11, Peiyu Huang1, Heshen Tian1, Jieqi Peng1, Shan Xiao1, Xiang Wen1, Huajing Yang1, Youlan Zhen1..., Zihui Wang1, Ningning Zhao1, Lifei Lu1, Jianwu Xu1, Qiuyue Wang3,**, Pixin Ran1,2,

, for the China Carbocysteine in Mild-to-moderate COPD Study Group Ver más

1 State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, Guangzhou, China

2 Guangzhou Laboratory, Bio-land, Guangzhou, China

3 Department of Pulmonary and Critical Care Medicine, Institute of Respiratory Disease, The First Hospital of China Medical University, Shenyang, China

4 Department of Respiratory and Critical Care Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

5 Respiratory Department of Tianjin Medical University General Hospital, Tianjin, China

6 The First Hospital of Wenzhou Medical University, Wenzhou, China

7 Department of Pulmonary and Critical Care Medicine, Shenzhen Institute of Respiratory Diseases, Shenzhen People's Hospital, The Second Clinical Medical College, Jinan University, The First Affiliated Hospital, Southern University of Science and Technology, Shenzhen, Guangdong Province, China

8 Department of Respiratory Medicine, School of Medicine, Ruijin North Hospital, Shanghai Jiao Tong University, Shanghai, China

9 Department of Pulmonary and Critical Care Medicine, the Second Xiangya Hospital, Central South University, Changsha, Hunan, China; Research Unit of Respiratory Disease, Central South University, Changsha, Hunan, China; Clinical Medical Research Center for Pulmonary and Critical Care Medicine in Hunan Province, Changsha, Hunan, China; Diagnosis and Treatment Center of Respiratory Disease, Central South University, Changsha, Hunan, China

10 Department of Respiratory Medicine, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China

11 Key Laboratory of Respiratory Disease of Zhejiang Province, Department of Respiratory and Critical Care Medicine, Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

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Abstract

Objectives: Carbocysteine can reduce the frequency of acute exacerbations and improve symptoms to a certain extent in severe to very severe chronic obstructive pulmonary disease (COPD) patients. The objective of the study was to evaluate the efficacy of carbocysteine on the rate of exacerbations and pulmonary function for mild-to-moderate COPD patients.

Methods: In this phase 4, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial, we randomly assigned mild-to-moderate COPD patients in a 2:1 ratio to treatment with carbocysteine (500mg, thrice daily) or matched placebo for 48 weeks. Eligible participants were 40-80 years of age. The coprimary outcomes were the annual rate of exacerbations of COPD (mild, moderate or severe) during the 48-week trial period or the difference in the FEV1 before bronchodilator use at 48-week from baseline.

Results: Owing to slower-than-anticipated recruitment caused by the COVID-19 pandemic, recruitment of an estimated sample size of 732 patients stopped after 539 patients. The sample size was indeed reached for the annual rate of exacerbations but not for pulmonary function. Among 539 patients, 362 were randomized to receive carbocysteine and 177 to receive matched placebo. There was no significant difference in the annual rate of exacerbations of COPD between carbocysteine group and placebo group (0.39 vs. 0.46 per patient year; relative risk [RR], 0.85; 95% confidence interval [CI], 0.64–1.13; P = 0.273). Based on the available sample size, the difference in the change of FEV1 before bronchodilator use at 48 weeks between carbocysteine group and placebo group has not been observed (46±10 vs. 49±14 ml; mean difference, 4; 95% CI, -29–36; adjusted P = 0.827).

Conclusions: Our findings suggested that carbocysteine might not significantly reduce the annual rate of total exacerbations in patients with mild-to-moderate COPD. The findings may have been compromised by an overestimation of the efficacy of carbocysteine on reducing exacerbations in mild-to-moderate COPD and potential confounding by baseline imbalances. The efficacy on lung function could not be adequately evaluated.

Clinical trial registered with Chictr.org.cn (ChiCTR1800016712).

Keywords:

carbocysteine

exacerbations

lung function

mild-to-moderate COPD

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These authors contributed equally: Yumin Zhou, Fan Wu, Haiqing Li, Zhishan Deng, Li Lin, Hong Huang, Haiyan Zhao, Yiran Wang, Lingwei Wang, Qijian Chen, Shan Cai.

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