article appraised is a randomized, double-blind, placebo-controlled
trial in which 87 CF patients older than 6 years of age, colonized with
P. aeruginosa, with FEV1 > 30% predicted received 250mg of azithromycin
po Monday, Wednesday, Friday (500mg if > 40kg) for 24 weeks while
98 received placebo.1
criteria included colonization with B. cepacia or nontuberculous mycobacteria,
GI manifestations of cystic fibrosis, or recent initiation of concomitant
therapies like tobramycin nebs, oral steroids, antibiotics, or pulmozyme.
primary outcome evaluated was the change in FEV1% predicted. Secondary
outcomes included changes in: body weight, time until first pulmonary
exacerbation, number of pulmonary exacerbations, hospitalization rates,
use of nonquinolone antibiotics, inflammatory markers, and quality of
improvement of FEV1% predicted in the azithromycin group was established
by 28 days of therapy but returned to pre-treatment levels 4 weeks after
treatment was discontinued.
azithromycin group was found to have more occurrences of wheezing, nausea,
and diarrhea than the placebo group.
was little difference between the azithromycin group and the placebo
group in emergence or eradication of multidrug resistant strains of
P. aeruginosa or nontuberculous mycobacteria.
randomized, double-blind, placebo-controlled, crossover trial of azithromycin
in children with cystic fibrosis found a median relative difference
in FEV1 between azithromycin and placebo of 5.4%.2