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

Elborn, J. Stuart and Geller, David E. and Conrad, Douglas and Aaron, Shawn D. and Smyth, Alan R. and Fischer, Rainald and Kerem, Eitan and Bell, Scott C. and Loutit, Jeffery S. and Dudley, Michael N. and Morgan, Elizabeth E. and VanDevanter, Donald R. and Flume, Patrick (2015) 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. Journal of Cystic Fibrosis, 14 (4). pp. 507-514. ISSN 1873-5010

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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 FEV1 % predicted change was the primary endpoint. Time to exacerbation and patient-reported quality of life superiority 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%]). LIS was well-tolerated, with dysguesia (taste distortion) the most frequent adverse event.

Conclusions: LIS is a safe and effective therapy for the management of CF patients with chronic P. aeruginosa.

Item Type: Article
Keywords: cystic fibrosis, antibiotics, Pseudomonas, aerosol, fluoroquinolone
Schools/Departments: University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Division of Child Health, Obstetrics and Gynaecology
Identification Number: https://doi.org/10.1016/j.jcf.2014.12.013
Depositing User: Smyth, Prof Alan
Date Deposited: 15 Feb 2016 09:07
Last Modified: 02 Dec 2016 22:08
URI: http://eprints.nottingham.ac.uk/id/eprint/31682

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