Children and adolescents with cystic fibrosis who received the antibiotic azithromycin did not experience improved lung function, compared with patients who received placebo, according to a study published in the May 5 issue of the Journal of the American Medical Association.
"A vicious cycle of infection and inflammation causes progressive lung destruction and premature death in patients with cystic fibrosis (CF)," the authors wrote. "Treatment strategies have therefore included both antimicrobial and anti-inflammatory agents."
There has been increasing evidence over the past decade that azithromycin, an antibiotic with both antimicrobial and anti-inflammatory activity, benefits individuals with CF. "Azithromycin is recommended as therapy for CF patients with chronic Pseudomonas aeruginosa infection, but there has not been sufficient evidence to support the benefit of azithromycin in other patients with CF," they wrote.
Lisa Saiman, MD, Columbia University, New York, New York, and colleagues conducted a randomised, placebo-controlled trial involving children and adolescents with CF who were uninfected with P aeruginosa to determine if azithromycin would improve lung function or reduce pulmonary exacerbations. The trial was conducted from February 2007 to July 2009 at 40 CF care centres in the United States and Canada.
Of the 324 participants screened, 260 met study criteria, were randomised and received either the study drug (n = 131) or placebo (n = 129). The average age of the participants was 10.7 years.
The researchers found that treatment with azithromycin for 24 weeks, compared with placebo, did not result in improved pulmonary function, as measured by the change in forced expiratory volume in 1 second (FEV1).
"However, analyses of exploratory end points demonstrated that when compared with the placebo group, the azithromycin group had a 50% reduction in pulmonary exacerbations, 27% reduction in the initiation of new oral antibiotics (other than azithromycin), some weight gain, and 0.34-unit increase in body mass index," the authors wrote. "There were no differences in treatment groups in the use of intravenous or inhaled antibiotics or hospitalizations."
Participants in the azithromycin group had less cough and less productive cough, compared with placebo participants.
"Further studies of azithromycin are warranted to further investigate its potential use in this population," the researchers concluded.
Source: Journal of the American Medical Association