1. Ambroxol hydrochloride spray (Luo Runchang®) in the treatment of acute respiratory infectious diseases: a prospective, multicenter, open label, randomized controlled study
- Author
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Lu Cheng, Min Liu, Rong Wang, Sufen Cao, Rui Li, Bo Su, Hongyan Wei, Haijuan Yang, Lingyun Hou, Chunyu Geng, Yuling Han, and Tianrui Yang
- Subjects
ambroxol ,lower respiratory tract infection (LRTI) ,ambroxol hydrochloride ,pediatric medicine ,respiratory infection ,Pediatrics ,RJ1-570 - Abstract
PurposeCough and sputum are the most common clinical symptoms of acute respiratory tract infection. Ambroxol is a mucolytic expectorant commonly used in clinical practice. This study aimed to evaluate the efficacy, safety, and compliance of ambroxol hydrochloride spray (Luo Runchang ®) for the treatment of acute respiratory tract diseases in children.MethodsThis was a multicenter, open-labeled, randomized controlled study. The experimental group received ambroxol hydrochloride oral sprays, and the control group received ambroxol hydrochloride oral solutions. The primary endpoint was the change in cough symptom scores from baseline. Secondary endpoints include changes in cough severity score, quality of life, adherence, and adverse events.ResultsA total of 154 subjects were randomized and included in the analysis. The mean change of total cough symptom score of the spray group at the end of treatment was −4.7 (1.54) compared to −4.2 (1.62) in the solution group (P = 0.0005). The mean change of cough severity score was −5.7 (2.09) in the spray group compared to −5.2(2.04) in the solution group (P = 0.012). Quality of life scores significantly improved in the spray group (P
- Published
- 2024
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