TY - JOUR
T1 - 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
T2 - Erase
AU - Gao, Yong-Hua
AU - Lu, Hai-Wen
AU - Zheng, Hui-Zhen
AU - Cao, Chao
AU - Chu, De-Jie
AU - Fan, Hong
AU - Fan, Xiao-Yun
AU - Gu, Hong-Yan
AU - Guan, Wei-Jie
AU - Jie, Zhi-Jun
AU - Jin, Yang
AU - Li, Wen
AU - Li, Yu-Ping
AU - Li, Yuan-Yuan
AU - Liu, Lin
AU - Liu, Xue-Dong
AU - Luo, Hong
AU - Lv, Xiao-Dong
AU - Mo, Wei-Qiang
AU - Song, Yuan-Lin
AU - Wang, Dao-Xin
AU - Wang, Ling-Wei
AU - Wang, Chang-Zheng
AU - Xie, Min
AU - Zhang, Min
AU - Zheng, Cui-Xia
AU - Mao, Bei
AU - Chotirmall, Sanjay H.
AU - Chalmers, James D.
AU - Qu, Jie-Ming
AU - Xu, Jin-Fu
AU - ERASE study group
N1 - Publisher Copyright:
© 2024, European Respiratory Society. All rights reserved.
PY - 2024/2/26
Y1 - 2024/2/26
N2 - Chronic Pseudomonas aeruginosa (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 date no randomised trial has evaluated the benefit of different PA eradication strategies in bronchiectasis patients. The ERASE trial will therefore generate crucial data to inform future clinical guidelines.
AB - Chronic Pseudomonas aeruginosa (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 date no randomised trial has evaluated the benefit of different PA eradication strategies in bronchiectasis patients. The ERASE trial will therefore generate crucial data to inform future clinical guidelines.
UR - http://www.scopus.com/inward/record.url?scp=85187640626&partnerID=8YFLogxK
U2 - 10.1183/23120541.00938-2023
DO - 10.1183/23120541.00938-2023
M3 - Article
C2 - 38410702
SN - 2312-0541
VL - 10
JO - ERJ Open Research
JF - ERJ Open Research
IS - 1
M1 - 00938-2023
ER -