Effect of formoterol fumarate treatment on exercise-induced bronchoconstriction in children.
BACKGROUND
Exercise-induced bronchoconstriction (EIB) is common, particularly in children.


OBJECTIVE
To compare the protective effect of single doses of formoterol fumarate via Aerolizer with placebo and albuterol in children with EIB.


METHODS
In this randomized, double-blind, double-dummy, crossover trial, 23 children (aged 4-11 years) received formoterol, 12 or 24 microg; albuterol, 180 microg; or placebo at 4 separate visits. Protection against EIB was evaluated as the maximum percentage decrease in forced expiratory volume in 1 second (FEV1) from the preexercise value after exercise challenge tests (6-minute treadmill) conducted 15 minutes and 4, 8, and 12 hours after administration of the dose.


RESULTS
The maximum percentage decrease in FEV1 after the 4-hour exercise test (primary efficacy variable) was significantly less for formoterol, 12 and 24 microg, vs placebo (P < .001 for both) or albuterol (P = .016 and .010, respectively); albuterol was not significantly different from placebo. Formoterol, 12 and 24 microg, differed from placebo at 8 hours (P = .002 and .001, respectively), with a smaller difference between albuterol and placebo (P = .045). Rescue medication use and a high dropout rate may have biased treatment differences at later time points. Protection against EIB (<20% maximum decrease in FEV1) across all time points was observed for 17 (77%) of 22 and 17 (74%) of 23 children with formoterol, 12 and 24 microg, respectively, compared with 8 (35%) of 23 with albuterol and 6 (27%) of 22 with placebo.


CONCLUSIONS
Single doses of formoterol, 12 or 24 microg, are effective in protecting against EIB in children, affording a statistically significantly greater protective effect than placebo or albuterol.
Pearlman
David
D
Colorado Allergy and Asthma Centers PC, Denver, USA.
Milgrom
Henry
H
Till
Denise
D
Ziehmer
Barbara
B
D000280:Administration, Inhalation; D000420:Albuterol / Q000627:therapeutic use; D001250:Asthma, Exercise-Induced / Q000517:prevention & control*; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004983:Ethanolamines / Q000008:administration & dosage*; D005080:Exercise Test; D005541:Forced Expiratory Volume / Q000187:drug effects; D000068759:Formoterol Fumarate; D006801:Humans
D001993:Bronchodilator Agents; D004983:Ethanolamines; D000420:Albuterol; D000068759:Formoterol Fumarate