Stelmach I, Grzelewski T, Majak P, Jerzynska J, Stelmach W, Kuna P. J Allergy Clin Immunol. 2008;121(2):383–389
PURPOSE OF THE STUDY. To compare the effectiveness of different patterns of antiasthmatic treatments to protect children from exercise-induced bronchospasm (EIB).
STUDY POPULATION. This was a randomized, double-blind, placebo-controlled study of 100 children aged 6 to 18 years with atopic asthma sensitive only to house dust mites and EIB. Subjects must have had a resting forced expiratory volume in 1 second (FEV1) of ≥70% predicted and at least a 20% drop in FEV1 after exercise to qualify for the study.
METHODS. Participants were randomly assigned to a 4-week double-blind, placebo-controlled trial to receive 1 of the following treatments: (1) budesonide 100 μg + formoterol 4.5 μg twice daily; (2) budesonide 100 μg twice daily + montelukast 5 or 10 mg at bedtime; (3) montelukast 5 or 10 mg at bedtime; (4) budesonide 100 μg twice daily; or (5) placebo alone. All study arms had matching placebo medications from which active drugs were omitted (eg, group 1 had placebo tablets in place of montelukast, etc). At randomization and after 4 weeks on the study medication(s), a treadmill exercise test was performed to evaluate the effectiveness of treatment.
RESULTS. Ninety-one subjects with a median age of 11.3 to 12.2 among the groups completed the study. Preexercise FEV1 and EIB, as represented by the area under the curve of time-response curve and by maximum percentage decrease in FEV1 after exercise, did not differ at baseline between the groups. EIB was diminished with all treatments when compared with placebo. The effect of treatment with budesonide plus montelukast and with montelukast alone were greater than budesonide alone or budesonide plus formoterol (P < .001). The budesonide-plus-formoterol group was also better than budesonide alone, but these results did not reach significance (P = .59).
CONCLUSIONS. Budesonide plus montelukast or montelukast alone were the most effective treatments for EIB in children.
REVIEWER COMMENTS. This was the first study in asthmatic children that evaluated both monotherapy and combination therapy for the reduction of EIB. This study highlights the importance of controller therapy in childhood asthma and the effects on EIB between therapeutic options recommended for childhood asthma. In particular, consideration for the use of montelukast as monotherapy or in combination therapy with inhaled corticosteroids is indicated for EIB in children with similar asthmatic phenotypes.
- Copyright © 2008 by the American Academy of Pediatrics