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Open-label, follow-on study of azithromycin in pediatric patients with CF uninfected with pseudomonas aeruginosa
Pediatric Pulmonology, 01/20/2012
Saiman L et al. – During the open–label study, they observed continued durability of treatment response to azithromycin, as measured by pulmonary exacerbations and continued weight gain, although use of oral antibiotics increased. There were no new safety concerns. Currently available data suggest that azithromycin reduces exacerbations and improves weight gain for 6–12 months among children and adolescents with CF uninfected with P. aeruginosa.
Methods- Eligible participants were enrolled in a 24-week open-label study of azithromycin to compare efficacy and safety endpoints during the placebo-controlled trial versus open-label study in two groups: participants initially on azithromycin continued azithromycin (azithromycin–azithromycin) and participants initially on placebo who then received azithromycin (placebo–azithromycin).
- As in the placebo-controlled trial, the azithromycin dose in the open-label study was 250mg Monday–Wednesday–Friday for participants weighing 18–35.9kg and 500mg Monday–Wednesday–Friday for participants weighing 36kg or greater.
- Of 174 eligible participants, 146 (83.9%) enrolled in the open-label study.
- No significant improvements in lung function were observed within either group.
- There were no differences in outcomes in the placebo–azithromycin group during the placebo-controlled versus open-label phase.
- The azithromycin–azithromycin group had comparable odds of experiencing an exacerbation during the two phases (OR 1.6, CI95 0.8, 3.0) and stable weight gain, but new oral antibiotics were initiated more frequently during the open-label study (OR 1.9, CI95 1.0, 3.5).
- In both groups, adverse event rates were comparable during the placebo-controlled and open-label study and treatment-emergent pathogens were rare.