The effects of regular inhaled formoterol, budesonide, and placebo on mucosal inflammation and clinical indices in mild asthma

The present study was designed to observe the effects of 8 wk of treatment with formoterol (Foradil) 24 mu g, budesonide 400 mu g, and matched placebo inhaled twice a day on inflammatory indices in the bronchial mucosa of 64 patients with mild atopic asthma. Biopsies were obtained at the start and 1 wk before stopping a 9-wk period of treatment, and inflammatory cell numbe rs were assessed in the submucosa and epithelium by immunohistochemistry. R egular formoterol significantly reduced the number of submucosal mast cells , with a similar trend for eosinophils but not activated T cells. A subgrou p analysis conducted in biopsies with greater than or equal to 10 eosinophi ls per mm(2) revealed a significant reduction in eosinophil numbers when co mpared with both pretreatment baseline (p < 0.01) and changes after placebo (p < 0.01). Parallel, but less pronounced, effects were observed on mast c ell but not on CD25(+) T cell numbers. There was no effect of any of the th ree treatments on BAL levels of mast cell or eosinophil mediators. We concl ude that regular treatment with inhaled formoterol reduces rather than incr eases inflammatory cells in the mucosa of asthmatic patients. It is possibl e that these cellular effects of formoterol may contribute to the therapeut ic efficacy of this drug when used regularly in the treatment of asthma.