Efficacy and tolerability of formoterol Turbuhaler in children.
A 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 pmicro b.i.d. or placebo for 12 weeks. Morning PEF (primary variable), was significantly improved versus placebo only in the formoterol 9 pmicro b.i.d. group (13 l/min, 95% CCI 1.9, 24.2%; p = 0 .02). Both formoterol 4.5 and 9 pmicro 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 pmicro 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 micro b.i.d. is effective and well tolerated as maintenance therapy in children with mild to moderate asthma.
Von Berg
A
A
Marien Hospital, Wesel, Germany.
Papageorgiou Saxoni
F
F
Wille
S
S
Carrillo
T
T
Kattamis
C
C
Helms
P-J
PJ
D000280:Administration, Inhalation; D000293:Adolescent; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D002648:Child; D004311:Double-Blind Method; D004983:Ethanolamines / Q000008:administration & dosage*; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D009330:Nebulizers and Vaporizers; D010366:Peak Expiratory Flow Rate / Q000187:drug effects; D016896:Treatment Outcome
D001993:Bronchodilator Agents; D004983:Ethanolamines; D000068759:Formoterol Fumarate