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; 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

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.

Citation

Elborn, J. S., Geller, D. E., Conrad, D., Aaron, S. D., Smyth, A. R., Fischer, R., …Flume, P. (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), https://doi.org/10.1016/j.jcf.2014.12.013

• Journal Article Type: Article
• Publication Date: Jan 13, 2015
• Deposit Date: Feb 15, 2016
• Publicly Available Date: Feb 15, 2016
• Journal: Journal of Cystic Fibrosis
• Print ISSN: 1569-1993
• Electronic ISSN: 1873-5010
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 14
• Issue: 4
• DOI: https://doi.org/10.1016/j.jcf.2014.12.013
• Keywords: cystic fibrosis, antibiotics, Pseudomonas, aerosol, fluoroquinolone
• Public URL: https://nottingham-repository.worktribe.com/output/743339
• Publisher URL: http://www.sciencedirect.com/science/article/pii/S1569199314003105