@article {Pearlman:September 2006:1081-1206:382, author = "Pearlman, David", author = "Milgrom, Henry", author = "Till, Denise", author = "Ziehmer, Barbara", title = "Effect of formoterol fumarate treatment on exercise-induced bronchoconstriction in children", journal = "Annals of Allergy, Asthma and Immunology", volume = "97", year = "September 2006", abstract = "Background: Exercise-induced bronchoconstriction (EIB) is common, particularly in children.
Objectives: 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 μg; albuterol, 180 μg; 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 μg, vs placebo (P < .001 for both) or albuterol (P = .016 and .010, respectively); albuterol was not significantly different from placebo. Formoterol, 12 and 24 μg, 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 μg, respectively, compared with 8 (35%) of 23 with albuterol and 6 (27%) of 22 with placebo. Conclusions: Single doses of formoterol, 12 or 24 μg, are effective in protecting against EIB in children, affording a statistically significantly greater protective effect than placebo or albuterol.", pages = "382-388(7)", url = "http://www.ingentaconnect.com/content/acaai/aaai/2006/00000097/00000003/art00020" }