Abstract
Aim: The purpose of this study was to evaluate the effectiveness and safety of Aromaforce® Junior Cough Syrup (AJCS) in treating acute upper respiratory tract infection-related coughs in children, and it served as a post-marketing clinical follow-up. Methods: Prospective, multicenter, open-label, controlled clinical investigation conducted under normal conditions of use to evaluate the antitussive effectiveness of a mucilage-based syrup in pediatric patients (aged 2 to 12 years) as compared to increased hydration measures (control group), with a 1-week follow-up. Likert severity scores were used to evaluate coughs and related symptom severity. Results: The results demonstrate that AJCS effectively reduces cough severity, including daytime and night-time cough, and the number of times the child was woken up, particularly within the first three days, surpassing the effectiveness of hydration measures. The results of the degree of satisfaction with AJCS show that the majority of physicians and parents had positive feedback. Furthermore, the safety analysis confirms the syrup's non-toxic nature in children. However, the initial differences in baseline characteristics between the study and control groups, with the study group exhibiting higher combined cough scores, limit the strength of the evidence. Conclusions: This study provides further evidence supporting the efficacy and safety of AJCS in the treatment of cough associated with acute upper respiratory tract infections in children. Further randomized studies may provide further evidence of the efficacy and safety of AJCS.