title: Effect of formoterol fumarate treatment on exercise-induced bronchoconstriction in children.
abstract: 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.
authors.affiliation: Colorado Allergy and Asthma Centers PC, Denver, USA.
authors.forename: David
authors.initials: D
authors.lastname: Pearlman
authors.forename: Henry
authors.initials: H
authors.lastname: Milgrom
authors.forename: Denise
authors.initials: D
authors.lastname: Till
authors.forename: Barbara
authors.initials: B
authors.lastname: Ziehmer
mesh_terms: 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
chemical_list: D001993:Bronchodilator Agents; D004983:Ethanolamines; D000420:Albuterol; D000068759:Formoterol Fumarate