Efficacy and safety of flupentixol-melitracen in patients with refractory chronic cough: a randomised, double-blinded, placebo-controlled clinical trial

作者：Qiang Chen, Mengru Zhang, Li Zhang, Alimire Aierken, Ran Dong, Xianghuai Xu, Yu Li, Kefang Lai, Zhongmin Qiu · 发表于：EClinicalMedicine · 年份：2025 · DOI：10.1016/j.eclinm.2025.103367 · 被引用次数：3 · 研究领域：Respiratory and Cough-Related Research、Pharmacological Receptor Mechanisms and Effects、Asthma and respiratory diseases

Background: The antitussive potential of flupentixol-melitracen, an anti-anxiety and anti-depression compound, has been observed previously. We aimed to further evaluate its efficacy and safety in patients with refractory chronic cough (RCC) who were unresponsive to any other available treatments. Methods: This randomised, double-blinded, placebo-controlled clinical trial was conducted at a single specialist cough clinic in Tongji Hspital, Shanghai, China. Adults aged 18-69 years with RCC and persistent cough despite at least two weeks of neuromodulator therapy were enrolled. Participants were randomly assigned (1:1) to receive either oral flupentixol-melitracen (flupentixol 0.5 mg + melitracen 10 mg), one tablet twice daily, or matching placebo, for two weeks, followed by a one week of off-treatment safety monitoring. Randomisation was computer-generated, with masking of participants, investigators, and outcome assessors. The co-primary endpoints were cough resolution rate (≥50% reduction in cough symptom score [CSS]) at visit four and placebo-adjusted change in CSS over time. The full analysis set (FAS) was used following the modified intention-to-treat (mITT) principle for demographic baseline analysis and efficacy analysis. The safety set (SS) was used for safety analysis and included all patients who took at least one dose of treatment and had post-dose safety records. The FAS and SS were equivalent in this study. The trial is registered with the Chinese Clinical Trial R...