A phase 3, multi-center, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of levofloxacin inhalation.

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A phase 3, multi-center, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of levofloxacin inhalation solution (APT-1026) in stable cystic fibrosis patients Patrick A. Flume, Donald R. VanDevanter, Elizabeth E. Morgan, Michael N. Dudley, Jeffery S. Loutit, Scott C. Bell, Eitan Kerem, Rainald Fischer, Alan R. Smyth, Shawn D. Aaron, Douglas Conrad, David E. Geller, J. Stuart Elborn Journal of Cystic Fibrosis Volume 15, Issue 4, Pages 495-502 (July 2016) DOI: 10.1016/j.jcf.2015.12.004 Copyright © 2015 European Cystic Fibrosis Society Terms and Conditions

Fig. 1 Patient disposition. Journal of Cystic Fibrosis 2016 15, 495-502DOI: (10.1016/j.jcf.2015.12.004) Copyright © 2015 European Cystic Fibrosis Society Terms and Conditions

Fig. 2 Time to protocol-defined exacerbation by treatment group. Gray boxes denote on-treatment period. Solid circles and lines denote LIS, open circles and dashed lines denote TIS. Circles represent times at which patients were censored from the analysis. Journal of Cystic Fibrosis 2016 15, 495-502DOI: (10.1016/j.jcf.2015.12.004) Copyright © 2015 European Cystic Fibrosis Society Terms and Conditions

Fig. 3 Mean absolute change from baseline in FEV1% predicted and change from baseline in sputum P. aeruginosa density by treatment group. Shaded area denotes on-treatment periods. Solid circles and lines denote LIS, open circles and dashed lines denote placebo. Bars represent standard errors. Panel A: Mean absolute change from baseline in FEV1% predicted. Panel B: Mean change from baseline in log10 P. aeruginosa colony-forming units per gram sputum. Differences between treatment groups were statistically significant at day 28. LS=least squares. Journal of Cystic Fibrosis 2016 15, 495-502DOI: (10.1016/j.jcf.2015.12.004) Copyright © 2015 European Cystic Fibrosis Society Terms and Conditions

Fig. 4 Post hoc hazard ratios (LIS patients/placebo patients) for modified Fuchs exacerbation or treatment with antipseudomonal antibiotics stratified by prior IV-treated exacerbation subgroups. Hazard ratios were derived using the Kaplan–Meier survival method. Closed circles show results for the entire study population. Open circles show results for patient subgroups defined by the number of IV-treated exacerbations patients had experienced in the prior year. Bars show 95% confidence intervals and P values are derived from log rank tests. Journal of Cystic Fibrosis 2016 15, 495-502DOI: (10.1016/j.jcf.2015.12.004) Copyright © 2015 European Cystic Fibrosis Society Terms and Conditions