Florensocatib in adults with bronchiectasis: The HOPE-BE trial protocol and baseline demographic characteristics
作者:N. Zhong, Jie Cao, Yan Feng, Xun-chao Liu, Guo-jun Zhang, Huan Ye, Zhi-jun Liang, Hui Shen, Zhang Bao, Zhi-Ren Yang, Ling-feng Min, Hui Jiang, Rong Qiu, Jian-ping Liang, Jiayi Liu, Li-min Dong, Xin-yu Song, Jinxiang Wang, Yanming Huang, Fangqiong Li, Lu-yin Sun, Han-mo Liu, Wei‐jie Guan · 发表于:ERJ Open Research · 年份:2026 · DOI:10.1183/23120541.00182-2026 · 被引用次数:1 · 研究领域:Cystic Fibrosis Research Advances、Chronic Obstructive Pulmonary Disease (COPD) Research、Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis
Background Florensocatib (formerly known as HSK31858) is a novel reversible inhibitor of dipeptidyl peptidase 1. We sought to determine the efficacy and safety of florensocatib in decreasing exacerbation frequency in Chinese adults with bronchiectasis. Methods The HOPE-BE trial was a phase 3, randomized, placebo-controlled trial which determines the efficacy and safety of high-dose florensocatib (40 mg once daily) versus placebo in Chinese adults with bronchiectasis who two or more exacerbations within the past year. Patients were randomly assigned in a 2:1 ratio to receive florensocatib 40 mg or matching placebo once daily for 52 weeks. We recorded demographics, medical history, bacterial infection status, quality-of-life and performed spirometry at baseline. Results We randomized 700 patients who were enrolled from 67 sites in mainland China between September 2024 and November 2025. 60.4% of patients were females. 559 (79.9%) and 141 (20.1%) of patients, respectively, had two and three or more exacerbations in the past year. The median (interquartile range) of 24-hour sputum weight was 14.8 (29.3) grams, and the median (interquartile range) of sputum purulence score was 5.0 (2.0). 192 (27.4%) patients culture positive to Pseudomonas aeruginosa , who demonstrated significantly higher 24-hour sputum volume and purulence score, and lower lung function and quality-of-life scores. Significant geographic variations were seen regarding comorbidity, blood eosinophil counts and sput...