Azithromycin in Patients With Cystic Fibrosis Chronically Infected With Pseudomonas aeruginosa: A Randomized Controlled Trial

CONTEXT Treatment strategies for cystic fibrosis (CF) lung disease include antibiotics, mucolytics, and anti-inflammatory therapies. Increasing evidence suggests that macrolide antibiotics might be beneficial in patients with CF. OBJECTIVE To determine if an association between azithromycin use and pulmonary function exists in patients with CF. DESIGN AND SETTING A multicenter, randomized, double-blind, placebo-controlled trial conducted from December 15, 2000, to May 2, 2002, at 23 CF care centers in the United States. PARTICIPANTS Of the 251 screened participants with a diagnosis of CF, 185 (74%) were randomized. Eligibility criteria included age 6 years or older, infection with Pseudomonas aeruginosa for 1 or more years, and a forced expiratory volume in 1 second (FEV1) of 30% or more. Participants were stratified by FEV1 (≥60% predicted vs