Abstrakt
We aimed to compare the efficacy and safety of budesonide/formoterol (Symbicort(R)) with budesonide alone (Pulmicort(R)) or budesonide (Pulmicort) and formoterol (Oxis(R)) administered via separate inhalers in children with asthma. In a 12 wk, double-blind study, a total of 630 children with asthma (mean age 8 yr [4-11 yr]; mean forced expiratory volume in 1 s (FEV1) 92% predicted; mean inhaled corticosteroid dose 454 mu g/day) were randomized to: budesonide/formoterol (80/4.5 mu g, two inhalations twice daily); a corresponding dose of budesonide alone (100 mu g, two inhalations twice daily); or a corresponding dose of budesonide (100 mu g, two inhalations twice daily) and formoterol (4.5 mu g, two inhalations twice daily) (budesonide + formoterol in separate inhalers).
The primary efficacy variable was the change from baseline to treatment (average of the 12-wk treatment period) in morning peak expiratory flow (PEF). Other changes in lung function and asthma symptoms were assessed, as was safety.
Budesonide/formoterol significantly improved morning PEF, evening PEF and FEV1 compared with budesonide (all p < 0.001); there was no significant difference between budesonide/formoterol and budesonide + formoterol in separate inhalers for these variables. All other diary card variables improved from baseline in all treatment groups; there were no significant between-group differences.
Adverse-event profiles were similar in all groups; there were no serious asthma-related adverse events in any treatment group. Conclusion: budesonide/formoterol significantly improved lung function in children (aged 4-11 yr) with asthma compared with budesonide alone.
Budesonide/formoterol is a safe and effective treatment option for children with asthma.