Evaluation of safety and efficacy of inhaled ambroxol in hospitalized adult patients with mucopurulent sputum and expectoration difficulty

Zheng, Zeguang1; Yang, Kai2,3; Liu, Ni1; Fu, Xiuhua4; He, Huijie5; Chen, Hong6; Xu, Peijun7; Wang, Jing8; Liu, Maofeng9; Tang, Yuling10; Zhao, Fengzi11; Xu, Shufeng; Yu, Xiaowei; Han, Jichang14; Yuan, Bo15; Jia, Bin16; Pang, Guifen17; Shi, Yantong18; Kuang, Min19; Shao, Haiyan20; Xiong, Hao21; He, Jia22; Pan, Yuanyuan23; Chen, Rongchang2,3

2023-05-25

10.3389/fmed.2023.1182602

FRONTIERS IN MEDICINE   影响因子和分区

2296-858X

["Background: Ambroxol is a widely used mucoactive drug in sputum clearance of respiratory diseases taken orally and by injection. However, there is a paucity of evidence for inhaled ambroxol in sputum clearance.","Methods: This study performed a multicenter, randomized, double-blind, placebo-controlled, phase 3 trial at 19 centers in China. Hospitalized adult patients with mucopurulent sputum and expectoration difficulty were recruited. Patients were randomized by 1:1 to receive inhalation of either ambroxol hydrochloride solution 3mL (22.5mg)+0.9% sodium chloride 3 mL or 0.9% sodium chloride 6mL twice daily for 5days, with an interval of more than 6h. The primary efficacy endpoint was the absolute change in the sputum property score after treatment compared to the baseline in the intention-to-treat population.","Results: Between 10 April 2018 and 23 November 2020, 316 patients were recruited and assessed for eligibility, of whom 138 who received inhaled ambroxol and 134 who received a placebo were included. Patients who received inhaled ambroxol had a significantly greater decrease in the sputum property score compared with patients who received inhalation of placebo (difference: -0.29; 95% CI: -0.53 to -0.05; p=0.0215). Compared with the placebo, inhaled ambroxol also significantly reduced more expectoration volume in 24h (difference: -0.18; 95% CI: -0.34 to -0.03; p= 0.0166). There was no significant difference in the proportion of adverse events between the two groups, and no deaths were reported.","Discussion: In hospitalized adult patients with mucopurulent sputum and expectoration difficulty, inhaled ambroxol was safe and effective for sputum clearance compared with a placebo."]

inhaled ambroxol lower respiratory tract infection mucopurulent sputum expectoration difficulty safety efficacy

SCI

英语

通讯

General & Internal Medicine

Medicine, General & Internal

WOS:001004155400001

FRONTIERS MEDIA SA

Web of Science

1.Guangzhou Med Univ, Guangzhou Inst Resp Hlth, Natl Clin Res Ctr Resp Dis, State Key Lab Resp Dis,Affiliated Hosp 1, Guangzhou, Peoples R China
2.South Univ Sci & Technol, Shenzhen Inst Resp Dis, Shenzhen Peoples Hosp, Affiliated Hosp 1, Shenzhen, Peoples R China
3.Jinan Univ, Affiliated Hosp 2, Shenzhen, Peoples R China
4.Inner Mongolia Med Univ, Affiliated Hosp, Hohhot, Peoples R China
5.Inner Mongolia Univ Sci & Technol, Affiliated Hosp 1, Baotou Med Coll, Baotou, Peoples R China
6.Harbin Med Univ, Affiliated Hosp 2, Harbin, Peoples R China
7.Zibo Cent Hosp, Zibo, Peoples R China
8.Zhengzhou Univ, Affiliated Hosp 1, Zhengzhou, Peoples R China
9.PKU Care Luzhong Hosp, Zibo, Peoples R China
10.First Hosp Changsha, Changsha, Peoples R China
11.First Hosp Qiqihar, Qiqihar, Peoples R China
12.First Hosp Qinhuangdao, Qinhuangdao, Peoples R China
13.Changzhou 2 Peoples Hosp, Changzhou, Peoples R China
14.Second Nanning Peoples Hosp, Nanning, Peoples R China
15.Henan Univ, Huaihe Hosp, Kaifeng, Peoples R China
16.Siping Cent Peoples Hosp, Siping, Peoples R China
17.Xinjiang Med Univ, Affiliated Hosp 1, Urumqi, Peoples R China
18.Chengde Med Univ, Affiliated Hosp, Chengde, Peoples R China
19.Peoples Hosp Rizhao, Rizhao, Peoples R China
20.First Peoples Hosp Wenling, Wenling, Peoples R China
21.Second Peoples Hosp Yibin, Yibin, Peoples R China
22.Naval Med Univ, Fac Med Serv, Dept Hlth Stat, Shanghai, Peoples R China
23.Yingu Pharmaceut Co Ltd, Beijing, Peoples R China

Zheng, Zeguang,Yang, Kai,Liu, Ni,et al. Evaluation of safety and efficacy of inhaled ambroxol in hospitalized adult patients with mucopurulent sputum and expectoration difficulty[J]. FRONTIERS IN MEDICINE,2023,10.

Zheng, Zeguang.,Yang, Kai.,Liu, Ni.,Fu, Xiuhua.,He, Huijie.,...&Chen, Rongchang.(2023).Evaluation of safety and efficacy of inhaled ambroxol in hospitalized adult patients with mucopurulent sputum and expectoration difficulty.FRONTIERS IN MEDICINE,10.

Zheng, Zeguang,et al."Evaluation of safety and efficacy of inhaled ambroxol in hospitalized adult patients with mucopurulent sputum and expectoration difficulty".FRONTIERS IN MEDICINE 10(2023).