EFFICACY AND TOLERABILITY OF FORMOTEROL TURBUHALER® IN CHILDREN

Abstract

SUMMARYA randomised, double‐blind trial was undertaken to investigate the efficacy and tolerability of formoterol Turbuhaler® in children with mild to moderate asthma. After a two‐week run‐in, 248 children aged 6–17 years were randomised to receive formoterol 4.5 and 9 ug b.i.d. or placebo for 12 weeks. Morning PEF (primary variable), was significantly improved versus placebo only in the formoterol 9 ug b.i.d. group (13 l/min, 95% CI: 1.9, 24.2%; p=0.02). Both formoterol 4.5 and 9 ug significantly increased the pre‐bronchodilator FEV1 by 5.2–6.7% (p<0.05) and reduced use of daytime relief medication versus placebo (p<0.05). Formoterol 9 ug significantly reduced night‐time reliever use and awakenings due to asthma versus placebo (p<0.05). Both doses of formoterol were as well tolerated as placebo. In conclusion, formoterol 4.5 and 9 μg b.i.d. is effective and well tolerated as maintenance therapy in children with mild to moderate asthma.