Study Results

• What We Learned:

  Inhaled levofloxacin was generally well-tolerated; however, the study did not demonstrate a benefit after 28 days of treatment on reducing or delaying pulmonary exacerbations.

• Primary Findings:

  Effectiveness:

  Participants were recruited for this study between October 2010 and May 2012. The study enrolled 335 participants, aged 12 years and older. Participants were randomized to receive inhaled levofloxacin (N=220) or placebo (N=110). Of those entering the trial, 95.5% of participants who received inhaled levofloxacin and 99.1% of placebo participants completed the trial. Reasons for withdrawing from the study were similar between both treatment groups. The primary efficacy endpoint for the study was the time to an exacerbation of CF lung disease. No significant difference in time to pulmonary exacerbation was seen between the treatment groups. Therefore, the study did not achieve its primary endpoint of demonstrating superiority of inhaled levofloxacin over placebo in the time to a pulmonary exacerbation.

   

  Additional evaluations indicated that lung function (absolute change in FEV1% predicted) in inhaled levofloxacin treated participants showed an average improvement of 1.3% over placebo; however no difference was identified between the treatment groups on quality of life scores (CFQR-Q).

  Safety:

  The adverse event profile was similar for both the inhaled levofloxacin and placebo groups; however, inhaled levofloxacin treated participants complained more frequently about the taste of the medication.

• Citation:

  J Cyst Fibros 2016;DOI 10.1016/j.jcf.2015.12.004 [Epub ahead of print]

For current information about the overall development status of this drug, please check the Drug Development Pipeline.