Efficacy and safety of high-dose inhaled steroids in children with asthma:A comparison of fluticasone propionate with budesonide

Objective: To compare the efficacy and adverse effects of inhaled fluticaso ne propionate (FP), 400 mu g/d, with those of budesonide (BUD), 800 mu g/d, in children with moderate to severe asthma. Methods: Three hundred thirty-three children, ages 4 to 12 years, receiving inhaled corticosteroids were enrolled in a double-blind, double-dummy, ran domized, parallel-group study, After a 2-week run-in phase, 166 children re ceived FP and 167 received BUD for 20 weeks. The primary outcome variable w as mean morning peak expiratory flow; the 2 treatments were to be regarded as equivalent if the 90% CI for the treatment difference was within +/- 15 L/min. Pulmonary function, height, and diary cards were assessed at each vi sit; and morning serum cortisol levels were determined before and after tre atment. Results: Baseline peak expiratory flow was similar, FP 236 +/- 72 (SD) L/mi n and BUD 229 +/- 74, increasing after treatment to 277 +/- 41 and 257 +/- 28, a difference between treatments of 12 L/min (90% CI 6-19 L/min; P = .00 2). Symptom control and use of rescue medication were the same: Cortisol le vels after treatment were 199 nmol/L (FP) and 183 nmol/L (BUD) (treatment r atio = 1.09; 90% CI 0.98-1.21; P = .172). Linear growth was less in those r eceiving BUD (mean difference, 6.2 mm; 95% CI 2.9-9.6; P = .0003). Conclusion: FP at half the dose was superior to BUD in improving peak expir atory flow and comparable in controlling symptoms. Growth was reduced with BUD compared with FP, but there was no difference in serum cortisol suppres sion or hepatic or renal function.