Study Results

• What We Learned:

  Study results showed that levofloxacin was not inferior to inhaled tobramycin as measured by lung function. The adverse event profile was similar for both the inhaled levofloxacin and tobramycin solution for inhalation groups; however, levofloxacin treated participants complained more frequently about the taste of the medication.

• Primary Findings:

  Effectiveness:

  Participants were recruited for the study between February 2011 and August 2012. In this study, 282 participants, aged 12 years and older were randomized to receive inhaled levofloxacin (N=189) or tobramycin solution for inhalation (N=93), of which 166 in the levofloxacin group and 83 in the tobramycin group completed the trial. The primary efficacy endpoint was non-inferiority in change in lung function (relative change in FEV1% predicted). The study met its primary endpoint and demonstrated that inhaled levofloxacin was not inferior to inhaled tobramycin. Although the change in lung function was greater in the inhaled levofloxacin group compared with inhaled tobramycin the difference did not demonstrate superiority.

   

  Additional evaluations showed that the number of participants hospitalized for a pulmonary exacerbation was significantly lower in the inhaled levofloxacin group versus the inhaled tobramycin group (p=0.04). Additionally, the quality of life scores (CFQR-Q) improved for those receiving inhaled levofloxacin versus the participants receiving inhaled tobramycin (p=0.05); however no difference in time to first pulmonary exacerbation was seen between treatment groups.

  Safety:

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

• Citation:

  J Cyst Fibros ;DOI 10.1016/j.jcf.2014.12.013

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