A long-term study of the antiinflammatory effect of low-dose budesonide plus formoterol versus high-dose budesonide in asthma

Adding inhaled long-acting beta(2)-agonists to a low dose of inhaled cortic osteroids (ICS), results in better clinical asthma control than increasing the dose of ICS. However, this approach may mask underlying airway inflamma tion. In a double-blind parallel-group study, we evaluated the effect of ad ding formoterol to a low dose of budesonide, compared with a higher dose of budesonide, on the composition of induced sputum, After a 4-wk run-in peri od of treatment with budesonide (800 mu g, twice daily), 60 patients with m oderate asthma were randomly assigned to a 1-yr treatment with 400 mu g of budesonide plus placebo, twice daily (BUD800), or 100 mu g of budesonide pl us 12 mu g of formoterol, twice daily (BUD200+F). All drugs were administer ed via Turbuhaler, Budesonide (800 mu g, twice daily) during run-in signifi cantly reduced median sputum eosinophils from 4.5 to 0.68%. No significant changes in the proportion of eosinophils, EG2(+) cells, other inflammatory cells, or ECP levels in sputum were observed over the ensuing 1-yr treatmen t with BUD200+F or BUD800. Clinical asthma control was not significantly di fferent between both groups. In conclusion, no significant differences in s putum markers of airway inflammation were observed during a 1-yr treatment with a low dose of inhaled budesonide plus formoterol compared with a highe r dose of budesonide.