A phase 3, open-label, randomized trial to evaluate the safety and efficacy of levofloxacin inhalation solution (APT-1026) versus tobramycin inhalation.

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Presentation transcript:

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 Journal of Cystic Fibrosis Volume 14, Issue 4, Pages 507-514 (July 2015) DOI: 10.1016/j.jcf.2014.12.013 Copyright © 2014 European Cystic Fibrosis Society. Terms and Conditions

Fig. 1 Study design. Patients were randomized 2:1 to receive LIS or TIS. Three cycles of 28day BID treatment followed by 28days off treatment were studied. Journal of Cystic Fibrosis 2015 14, 507-514DOI: (10.1016/j.jcf.2014.12.013) Copyright © 2014 European Cystic Fibrosis Society. Terms and Conditions

Fig. 2 Patient disposition. Journal of Cystic Fibrosis 2015 14, 507-514DOI: (10.1016/j.jcf.2014.12.013) Copyright © 2014 European Cystic Fibrosis Society. Terms and Conditions

Fig. 3 Mean changes from baseline in FEV1 % predicted and sputum P. aeruginosa density across the study by treatment group. Gray boxes denote on-treatment periods. Solid circles and lines denote LIS, and open circles and dashed lines denote TIS. Bars represent standard errors. Upper panel: Mean relative change from baseline in FEV1 % predicted. The LS mean for relative change in FEV1 percent predicted at day 28 was in favor of LIS, but the difference was not statistically significant (2.24%, p=0.15). Lower panel: Mean change from baseline in log10 P. aeruginosa colony-forming units per gram sputum. Journal of Cystic Fibrosis 2015 14, 507-514DOI: (10.1016/j.jcf.2014.12.013) Copyright © 2014 European Cystic Fibrosis Society. Terms and Conditions

Fig. 4 Time to exacerbation by treatment group. Gray boxes denote on-treatment periods. Solid circles and lines denote LIS, and open circles and dashed lines denote TIS. Circles represent times at which patients were censored from the analysis. Journal of Cystic Fibrosis 2015 14, 507-514DOI: (10.1016/j.jcf.2014.12.013) Copyright © 2014 European Cystic Fibrosis Society. Terms and Conditions

Fig. 1 LS mean relative change from baseline in CFQ-R Respiratory Domain scores by treatment group. Solid circles and lines denote LIS, and open circles and dashed lines denote TIS. Bars represent standard errors. Sample sizes are provided in parentheses. Journal of Cystic Fibrosis 2015 14, 507-514DOI: (10.1016/j.jcf.2014.12.013) Copyright © 2014 European Cystic Fibrosis Society. Terms and Conditions

Fig. 2 Proportions of patients for which the levofloxacin MIC of their most levofloxacin-resistant P. aeruginosa isolate increased, decreased, or remained unchanged from baseline to the end of the study. Patients randomized to receive TIS are shown in gray bars; LIS in black bars. The difference in patients with an increased levofloxacin MIC of their most resistant isolate was not significant (p=0.500). Journal of Cystic Fibrosis 2015 14, 507-514DOI: (10.1016/j.jcf.2014.12.013) Copyright © 2014 European Cystic Fibrosis Society. Terms and Conditions