Source
Study design (if review, criteria of inclusion for studies)
double blind randomized controlled trial (Saiman 2010 - PM20442386)
Participants
CF patients 6-18 years of age uninfected with Pseudomonas aeruginosa
Interventions
oral azithromycin
Outcome measures
White cell counts and differential, serum myeloperoxidase (MPO), high sensitivity C reactive protein (hsCRP), intracellular adhesion molecule 1 (ICAM 1), interleukin 6 (IL-6), calprotectin, serum amyloid A (SAA), and granulocyte colony stimulating factor (G-CSF) were measured at baseline, after 28 and 168 days of treatment in patients receiving either oral azithromycin or placebo.
Main results
Inflammatory markers were similar in both groups at baseline. HsCRP, MPO, SAA, and calprotectin, as well as the absolute neutrophil count (ANC), significantly decreased from baseline to Day 28 in the azithromycin group as compared to the placebo group (p < 0.05). This treatment effect was sustained at Day 168 for ANC, calprotectin and SAA (p < 0.05). 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 < 0.05). Except for weight (%), the associations remained significant for calprotectin; FEV(1)(L) and weight (%) remained significantly correlated with 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.
Authors' conclusions
In patients not infected with P. aeruginosa, oral azithromycin significantly reduced neutrophil counts and serum inflammatory markers within 28 days of initiating treatment.