Cath Lab Digest

A study published in the Journal of the American Medical Association [2010;303(17):1707-1715] has reported that a 24-week regimen of azithromycin therapy in children and adolescents with cystic fibrosis (CF) who were not infected with Pseudomonas aeruginosa did not result in improved pulmonary function, but did reduce pulmonary exacerbations and improve weight gain.

The multicenter, randomized, double-blind, placebo-controlled trial enrolled 260 patients and was conducted from February 2007 to July 2009. Previous studies had reported reduced pulmonary exacerbations, increased weight gain, or improved lung function with azithromycin, mainly among those with chronic P aeruginosa infection. With this in mind, the goal of the reported study was to determine if azithromycin therapy improved lung function, reduced pulmonary exacerbations, and was safe and well tolerated in the population of CF patients studied.

The study included CF patients who were between the ages of 6 and 18 years; had a weight of at least 18 kg; had a forced expiratory volume at 1 second (FEV₁) of at least 50% predicted; and ≥2 negative cultures of P aeruginosa obtained at least 1 year prior to randomization (could include a negative screening culture 7-14 days prior to randomization).

Participants were randomized to receive 250 mg of azithromycin (for those weighing 18.0-35.9 kg), 500 mg of azithromycin (for those weighing ≥36 kg), or placebo 3 times per week (Monday, Wednesday, and Friday) for 24 weeks.