Safety and efficacy of inhalable ambroxol hydrochloride aerosol for adult patients with respiratory diseases: an open-label, single-arm, multicentre study

作者：Jinfang Ma, Jinping Zheng, Liping Chen, Zhengguang He, Zuke Xiao, Xiaohong Yang, Gang Chen, YU Chang-li, Tianli Wang, Dan Zhu, Leihong Mao, Wei Wang, Zhenshan Wang, Xiaoju Zhang, Jie Meng, Xianwei Ye, Rui Chen, Jianqing Zhao, Ting Yang, Keying Xue, Zhiyi He, Baosong Xie, Xiaohong Chen, Ruifeng Zhang, Yuanlin Song, Weiquan Liang, Lin Su, Huili Zhu, Wanjun Yu, Yilan Sun, Jie Zhang, Xiaoping Ren, Faguang Jin, Shujuan Jiang, Tiantuo Zhang, Yi Hu, Zhancheng Gao, Gongping Chen · 发表于：BMJ Open Respiratory Research · 年份：2025 · DOI：10.1136/bmjresp-2023-002096 · 被引用次数：3 · 研究领域：Respiratory and Cough-Related Research、Inhalation and Respiratory Drug Delivery、Asthma and respiratory diseases

BACKGROUND: Airway mucus hypersecretion is a key pathophysiological feature in many respiratory diseases and could lead to airway obstruction and repeated infections, consequently accelerating disease progression, which impacts on pulmonary function and quality of life (QoL), highlighting the importance of mucolytic therapy targeting airway mucus hypersecretion. OBJECTIVES: To investigate the safety and efficacy of inhalable ambroxol hydrochloride aerosol for adult patients with respiratory diseases. DESIGN: An open-label, single-arm, multicentre postmarketing surveillance study. METHODS: Adult patients with acute or chronic respiratory diseases were eligible to receive aerosol inhalation of ambroxol hydrochloride (3 mL and 7.5 mg/mL) using a nebuliser two times per day given at least 6 hours apart between doses. The treatment lasted for a maximum of 7 days. The primary safety outcome was the frequency and severity of adverse events (AEs), and the primary efficacy outcome was changes in sputum scale scores. RESULTS: Among 1201 eligible patients, 1192 received study medication and were included in the full analysis set and the safety set. Any grade AEs occurred in 16.3% of the patients, including serious AEs in four (0.3%) patients. The three most frequent AEs were respiratory symptoms and signs (1.5%), nausea and vomiting (0.8%) and digestive tract symptoms and signs (0.7%). In the full analysis set, the patients showed a mean reduction of 77.6% (95% CI, 75.9% to 79.3%) in th...