A phase 4 multicentre, 2×2 factorial randomised, double-blind, placebo-controlled trial to investigate the efficacy and safety of tobramycin inhalation solution for Pseudomonas aeruginosa eradication in bronchiectasis: ERASE

作者：Yong‐hua Gao, Hai‐Wen Lu, Hui-Zhen Zheng, Chao Cao, De-Jie Chu, Hong Fan, Xiaoyun Fan, Hongyan Gu, Wei‐jie Guan, Zhijun Jie, Yang Jin, Wen Li, Yuping Li, Yuanyuan Li, Lin Liu, Xuedong Liu, Hong Luo, Xiaodong Lv, Weiqiang Mo, Yuanlin Song, Daoxin Wang, Ling-Wei Wang, Changzheng Wang, Min Xie, Min Zhang, Cuixia Zheng, Bei Mao, Sanjay H. Chotirmall, James D. Chalmers, Jieming Qu, Jin‐Fu Xu · 发表于：ERJ Open Research · 年份：2024 · DOI：10.1183/23120541.00938-2023 · 被引用次数：7 · 研究领域：Cystic Fibrosis Research Advances、Neonatal Respiratory Health Research、Tracheal and airway disorders

(PA) infection significantly contributes to morbidity and mortality in bronchiectasis patients. Initiating antibiotics early may lead to the eradication of PA. Here we outline the design of a trial (ERASE; NCT06093191) assessing the efficacy and safety of inhaled tobramycin, alone or with oral ciprofloxacin, in bronchiectasis patients with a new isolation of PA. This multicentre, 2×2 factorial randomised, double-blind, placebo-controlled, parallel-group trial includes a 2-week screening period, a 12-week treatment phase (with a combination of ciprofloxacin or a placebo at initial 2 weeks) and a 24-week follow-up. 364 adults with bronchiectasis and a new PA isolation will be randomly assigned to one of four groups: placebo (inhaled saline and ciprofloxacin placebo twice daily), ciprofloxacin alone (750 mg ciprofloxacin and inhaled saline twice daily), inhaled tobramycin alone (inhaled 300 mg tobramycin and ciprofloxacin placebo twice daily) or a combination of both drugs (inhaled 300 mg tobramycin and 750 mg ciprofloxacin twice daily). The primary objective of this study is to assess the proportion of patients successfully eradicating PA in each group by the end of the study. Efficacy will be evaluated based on the eradication rate of PA at other time points (12, 24 and 36 weeks), the occurrence of exacerbations and hospitalisations, time to first pulmonary exacerbations, patient-reported outcomes, symptom measures, pulmonary function tests and the cost of hospitalisations. To...