一项评估左氧氟沙星吸入溶液（APT-1026）与妥布霉素吸入溶液在稳定期囊性纤维化患者中的安全性和疗效的 3 期、开放标签、随机试验。
A phase 3, open-label, randomized trial to evaluate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation solution in stable cystic fibrosis patients.
机构信息
Centre for Infection and Immunity, Queen's University Belfast, BT9, UK.
Florida State University College of Medicine, Orlando, FL, United States.
出版信息
J Cyst Fibros. 2015 Jul;14(4):507-14. doi: 10.1016/j.jcf.2014.12.013. Epub 2015 Jan 13.
BACKGROUND
Inhaled antibiotics are standard of care for persons with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa airway infection. APT-1026 (levofloxacin inhalation solution, LIS) is fluoroquinolone in development. We compared the safety and efficacy of LIS to tobramycin inhalation solution (TIS) in persons ≥12 years old with CF and chronic P. aeruginosa infection.
METHODS
This multinational, randomized (2:1), non-inferiority study compared LIS and TIS over three 28-day on/off cycles. Day 28 FEV(1) % predicted relative change was the primary endpoint. Time to exacerbation and patient-reported quality of life were among secondary endpoints.
RESULTS
Baseline demographics for 282 subjects were comparable. Non-inferiority was demonstrated (1.86% predicted mean FEV(1) difference [95% CI -0.66 to 4.39%]). LIS was well-tolerated, with dysgeusia (taste distortion) as the most frequent adverse event.
CONCLUSIONS
LIS is a safe and effective therapy for the management of CF patients with chronic P. aeruginosa infection.
背景
吸入抗生素是囊性纤维化（CF）患者和慢性铜绿假单胞菌气道感染的标准治疗方法。APT-1026（左氧氟沙星吸入溶液，LIS）是一种正在开发的氟喹诺酮类药物。我们比较了 LIS 与妥布霉素吸入溶液（TIS）在≥12 岁 CF 患者和慢性铜绿假单胞菌感染患者中的安全性和疗效。
方法
这项多中心、随机（2:1）、非劣效性研究比较了 LIS 和 TIS 在三个 28 天的开/关周期中的疗效。第 28 天 FEV1（1）预测值的相对变化是主要终点。恶化时间和患者报告的生活质量是次要终点之一。
结果
282 名受试者的基线人口统计学数据相当。证明了非劣效性（1.86%预测的平均 FEV1 差异[95%CI-0.66 至 4.39%]）。LIS 耐受性良好，味觉障碍（味觉扭曲）是最常见的不良事件。
结论
LIS 是治疗 CF 患者慢性铜绿假单胞菌感染的一种安全有效的治疗方法。
Zotero 插件