Adherence to maintenance therapy is often poor in patients with asthma. Simplifying dosing regimens has the potential to improve both adherence and asthma-retated morbidity. In this 12-week, randomized, double-blind, double-dummy, parattel-group study, 617 patients with mild to moderate persistent asthma (mean forced expiratory volume in 1 s [FEV,] 78.5% predicted) who were not optimally controlled on inhaled corticosteroids (200-500pg/day) were randomized to once-daily budesonide/formoterot (80/4.5 tg, 2 inhalations in the evening), twice-daity budesonide/formoterol (80/4.5 pg, 1 inhalation), or a corresponding dose of budesonide once-daily (200pg, 1 inhalation in the evening). AR patients received budesonide (100pg twice daily) during a 2-week run-in. Changes in mean morning peak expiratory flow (PEF) were similar for od budesonide/formoterol (23.4 l/min) and twice-daily budesonide/formoterot (24.1 l/min), and both were greater than with budesonide (5.5 Unnin; both P < 0.001). Evening PEF, symptom-free days, reliever-free days, and asthma control days were improved with budesonide/ formoterol therapy vs. budesonide (P < 0.05 vs. budesonide for all variables). All treatments were well tolerated. Budesonide/formoterot administered once daily in the evening is a convenient treatment regimen that is as effective in improving asthma control as twice-daily dosing in patients with mild to moderate persistent asthma. (c) 2006 Elsevier Ltd. All rights reserved.
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