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The article discusses a study which investigated the link between azithromycin treatment and an improvement in lung function and a reduction in pulmonary exacerbations in pediatric cystic fibrosis (CF) patients uninfected with Pseudomonas aeruginosa. The researchers conducted a multicenter, randomized, double-blind placebo-controlled trial in the U.S. and Canada involving 260 participants. It was found that there was no link between treatment with the drug for 24 weeks and improved pulmonary function.

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 (FEV[sub 1]) of 30% or more. Participants were stratified by FEV[sub 1] (≥60% predicted vs <60% predicted), weight of less than 40 kg vs 40 kg or more, and CF center. Intervention: The active group (n = 87) received 250 mg (weight <40 kg) or 500 mg (weight ≥40 kg) of oral azithromycin 3 days a week for 168 days; placebo group (n = 98) received identically packaged tablets. Main Outcome Measures: Change in FEV[sub 1] from day 0 to completion of therapy at day 168 and determination of safety. Secondary outcomes included pulmonary exacerbations and weight gain. Results: The azithromycin group had a mean 0.097-L (SD, 0.26) increase in FEV[sub 1] at day 168 compared with 0.003 L (SD, 0.23) in the placebo group (mean difference, 0.094 L; 95% confidence interval [CI], 0.023-0.165; P = .009). Nausea occurred in 17% more participatns in the azithromycin group (P = .01), diarrhea in 15% more (P = .009), and wheezing in 13% more (P = .007). Participants in the azithromycin group had less risk of experiencing an exacerbation than participants in the placebo group (hazard ratio, 0.65; 95% CI, 0.44-0.95; P = .03) and weighed at the end of the study an average 0.7 kg more than participants receiv... [ABSTRACT FROM AUTHOR]