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
J Stuart Elborn, David E Geller, Douglas Conrad, Shawn D Aaron, Alan R Smyth, Rainald Fischer, Eitan Kerem, Scott C Bell, Jeffery S Loutit, Michael N Dudley, Elizabeth E Morgan, Donald R VanDevanter, Patrick A Flume, J Stuart Elborn, David E Geller, Douglas Conrad, Shawn D Aaron, Alan R Smyth, Rainald Fischer, Eitan Kerem, Scott C Bell, Jeffery S Loutit, Michael N Dudley, Elizabeth E Morgan, Donald R VanDevanter, Patrick A Flume
Abstract
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.
Trial registration: ClinicalTrials.gov NCT02109822.
Keywords: Aerosol; Antibiotics; Cystic fibrosis; Fluoroquinolone; Pseudomonas.
Copyright © 2014 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.
Source: PubMed