Journal
PEDIATRIC PULMONOLOGY
Volume 34, Issue 5, Pages 342-350Publisher
WILEY
DOI: 10.1002/ppul.10173
Keywords
asthma; children; Symbicort (R); budesonide; formoterol
Categories
Ask authors/readers for more resources
The aim of this study was to evaluate the efficacy (expressed as effect on lung function) and tolerability of Symbicort(R) (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 mug/day), were randomized to 12 weeks' treatment with either budesonide/formoterol 80/4.5 mug, two inhalations twice daily (n = 148), or an equivalent dose of budesonide 100 mug, two inhalations twice daily (n = 138). Efficacy variables included morning and evening peak expiratory flow (PEF), spirometery, asthma symptoms. and use of rescue medication (beta(2)-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. Budesonicle/formoterol was well-tolerated in children with moderate persistent asthma, (C) 2002 Wiley-Liss, Inc.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available