Budesonide/formoterol in a single inhaler versus inhaled corticosteroids alone in the treatment of asthma.

The aim of this study was to evaluate the efficacy (expressed as effect on lung function) and tolerability of Symbicort® (budesonide/formoterol in a single inhaler) in children with asthma. This was a double-blind, double-dummy, randomized, parallel-group, multicenter trial. After a 2–4-week run-in period, 286 asthmatic children (177 boys, 109 girls; mean age, 11 years; mean forced expiratory volume in 1 sec (FEV1), 75% predicted normal), previously treated with inhaled corticosteroids (average dose 548 μg/day), were randomized to 12 weeks' treatment with either budesonide/formoterol 80/4.5 μg, two inhalations twice daily (n = 148), or an equivalent dose of budesonide 100 μg, two inhalations twice daily (n = 138). Efficacy variables included morning and evening peak expiratory flow (PEF), spirometery, asthma symptoms, and use of rescue medication (β2-agonists). Serial FEV1 assessments were carried out on a subgroup of children (budesonide/formoterol, n = 41; budesonide, n = 40) at randomization and at week 12. Relative to baseline, morning PEF (primary variable) increased to a significantly greater extent with budesonide/formoterol than with budesonide alone (7.22% predicted normal vs 3.45% predicted normal; P < 0.001). Evening PEF also increased significantly with budesonide/formoterol (6.13% predicted normal vs. 2.73% predicted normal; P < 0.001), as did mean FEV1 and serial FEV1 measured over 12 hr (both P < 0.05). Similar improvements in asthma symptoms and rescue medication use were observed in both groups. The two treatment groups were similar in terms of their adverse-event profile and rates of discontinuation. Budesonide/formoterol in a single inhaler provided rapid improvements in PEF and FEV1 compared to inhaled budesonide alone. These improvements were sustained throughout the study period. Budesonide/formoterol was well-tolerated in children with moderate persistent asthma. Pediatr Pulmonol. 2002; 34:342–350. © 2002 Wiley-Liss, Inc.