کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
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6240331 | 1280420 | 2015 | 8 صفحه PDF | دانلود رایگان |
BackgroundInhaled 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 â¥Â 12 years old with CF and chronic P. aeruginosa infection.MethodsThis 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.ResultsBaseline demographics for 282 subjects were comparable. Non-inferiority was demonstrated (1.86% predicted mean FEV1 difference [95% CI â 0.66 to 4.39%]). LIS was well-tolerated, with dysgeusia (taste distortion) as the most frequent adverse event.ConclusionsLIS is a safe and effective therapy for the management of CF patients with chronic P. aeruginosa infection.
Journal: Journal of Cystic Fibrosis - Volume 14, Issue 4, July 2015, Pages 507-514