Study Results

• What We Learned:

• Primary Findings:

  Effectiveness:

  One hundred forty-six subjects were enrolled in this 24-week open-label, follow on study to the randomized, placebo-controlled trial of azithromycin in children 7-18 years of age with CF uninfected with P. aeruginosa. The study assessed the durability of response to azithromycin and continued safety of tolerability of prolonged usage. Two treatment groups were assessed: subjects initially on azithromycin who stayed on azithromycin vs subjects initially on placebo who received azithromycin. Durability of treatment response to azithromycin was observed in the azithromycin-azithromycin group as measured by rate of pulmonary exacerbation and continued weight gain.

   

  No significant improvements in lung function were observed with either of 2 treatment groups.

  Safety:

  Compared with the preceding placebo-controlled study, there were no new safety concerns for adverse events, laboratory abnormalities, or emergent pathogens. Continued safety and tolerability were observed.

• Citation:

  Pediatr Pulmonol 2012;47(7):641-8

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