HealthDay News — For children with cystic fibrosis (CF) and early Pseudomonas aeruginosa (Pa) infection, the risk of pulmonary exacerbation is significantly reduced with the addition of azithromycin to tobramycin inhalation solution (TIS), according to a study published online June 11 in the American Journal of Respiratory and Critical Care Medicine.
Nicole Mayer-Hamblett, PhD, from the University of Washington in Seattle, and colleagues conducted a randomized trial in children ages 6 months to 18 years with CF and early Pa. Children were given azithromycin (110 participants) or placebo (111 participants) three times weekly in addition to standardized TIS.
The trial reached the pre-specified interim boundary for efficacy, and consequently, enrollment was stopped early by the National Heart, Lung, and Blood Institute. The researchers found that compared with placebo, the risk of pulmonary exacerbation was significantly reduced by 44% in the azithromycin group. There was a significant 1.27kg increase in weight in the azithromycin versus the placebo group. There were no significant differences in microbiologic or other clinical or safety end points.
“Azithromycin was associated with a significant reduction in risk of pulmonary exacerbation and sustained improvement in weight but had no impact on microbiologic outcomes in children with early Pa,” the authors write.