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

作者：Elbom J Stuart; Geller David E; Conrad Douglas; Aaron Shawn D; Smyth Alan R; Fischer Rainald; Kerem Eitan; Bell Scott C; Loutit Jeffery S; Dudley Michael N; Morgan Elizabeth E; VanDevanter Donald R; Flume Patrick A^*

来源：Journal of Cystic Fibrosis, 2015, 14(4): 507-514.

DOI：10.1016/j.jcf.2014.12.013

• Cystic fibrosis
• Antibiotics
• Pseudomonas
• Aerosol
• Fluoroquinolone

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 FEV1 % 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 FEV1 difference [95% CI -0.66 to 4.39%]). US 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.

• 出版日期2015-7