• Chest · Nov 2012

    Randomized Controlled Trial

    Effect of azithromycin on systemic markers of inflammation in patients with cystic fibrosis uninfected with Pseudomonas aeruginosa.

    • Felix Ratjen, Lisa Saiman, Nicole Mayer-Hamblett, Larry C Lands, Margaret Kloster, Valeria Thompson, Peggy Emmett, Bruce Marshall, Frank Accurso, Scott Sagel, and Michael Anstead.
    • Division of Respiratory Medicine, Department of Pediatrics, SickKids Research Institute, The Hospital for Sick Children, Toronto, ON M5G 1X8, Canada. felix.ratjen@sickkids.ca
    • Chest. 2012 Nov 1;142(5):1259-66.

    BackgroundWhile the mechanism of action by which azithromycin exerts positive effects inpatients with cystic fibrosis remains unclear, evidence suggests that azithromycin may act as an immunomodulatory agent. We examined changes in systemic inflammatory markers in a doubleblind, randomized, controlled trial of oral azithromycin in patients 6-18 years of age with cystic fibrosis who were uninfected with Pseudomonas aeruginosa.MethodsWBC counts and differential, serum myeloperoxidase (MPO), high-sensitivity C reactive protein (hsCRP), intracellular adhesion molecule 1, IL-6, calprotectin, serum amyloid A (SAA),and granulocyte colony-stimulating factor (G-CSF) were measured at baseline and after 28 and 168 days of treatment in patients receiving either oral azithromycin or placebo.ResultsInflammatory markers were similar in both groups at baseline. HsCRP, MPO, SAA, calprotectin,and the absolute neutrophil count (ANC) significantly decreased from baseline today 28 in the azithromycin group compared with the placebo group ( P < .05). This treatment effect was sustained at day 168 for ANC, calprotectin, and SAA ( P < .05). Changes in hsCRP, calprotectin,and SAA at day 28 were negatively correlated with changes in FEV 1 (L) and FEV 1(% predicted), as well as both absolute and relative changes in weight ( P < .05). Except for weight (%),the associations remained significant for calprotectin; FEV 1 (L) and weight (%) remained significantly correlated with the 168-day change in hsCRP. The 168-day change in ANC was significantly correlated with changes in lung function, but not in weight; the change in G-CSF was significantly correlated with the change in weight (%) only.ConclusionsIn patients not infected with P aeruginosa , oral azithromycin significantly reduced neutrophil counts and serum inflammatory markers within 28 days of initiating treatment.Trial RegistryClinicalTrials.gov; No.: NCT00431964; URL: www.clinicaltrials.gov

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