Study Results

• What We Learned:

  Study results show that there was no significant difference in the rate of pulmonary exacerbations between the treatment groups. Additionally, the frequency of adverse events was similar across groups.

• Primary Findings:

  Effectiveness:

  This study was conducted between December 2004 and July 2009. A total of 304 participants were randomized to one of the four treatment group and most participants completed the study (between three and eight participants withdrew in the 4 treatment groups). The primary objective was to investigate if cycled antimicrobial treatment (with or without ciprofloxacin) reduced the time to first pulmonary exacerbation requiring intravenous antibiotics or hospital admission compared to culture-based therapy. There were no differences in the exacerbation rates between cycled and culture-based groups or between inhaled tobramycin with ciprofloxacin vs. inhaled tobramycin without ciprofloxacin.

   

  No significant differences were observed between the groups in the secondary endpoints of time to pulmonary exacerbation requiring any antibiotic usage (oral, IV or inhaled), weight gain, lung function or likelihood of P. aeruginosa positive respiratory cultures.

  Safety:

  Adverse events were similar across groups although respiratory events were more common in the groups assigned to receive oral ciprofloxacin.

• Citation:

  Arch Pediatr Adolesc Med 2011;165(9):847-856

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