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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

Authors

J. Stuart Elborn

David E. Geller

Douglas Conrad

Shawn D. Aaron

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ALAN SMYTH alan.smyth@nottingham.ac.uk
Professor of Child Health

Rainald Fischer

Eitan Kerem

Scott C. Bell

Jeffery S. Loutit

Michael N. Dudley

Elizabeth E. Morgan

Donald R. VanDevanter

Patrick 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 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.

Journal Article Type Article
Publication Date Jan 13, 2015
Journal Journal of Cystic Fibrosis
Print ISSN 1569-1993
Electronic ISSN 1873-5010
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 14
Issue 4
APA6 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), doi:10.1016/j.jcf.2014.12.013
DOI https://doi.org/10.1016/j.jcf.2014.12.013
Keywords cystic fibrosis, antibiotics, Pseudomonas, aerosol, fluoroquinolone
Publisher URL http://www.sciencedirect.com/science/article/pii/S1569199314003105
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by-nc-nd/4.0

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Copyright Statement
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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by-nc-nd/4.0





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