Combination drug therapy for the prevention of exercise-induced bronchoconstriction in children.
BACKGROUND
Sequential administration of a beta-agonist and cromolyn or nedocromil before exercise is recommended for patients whose symptoms are not controlled by beta-agonists alone; however, this practice reduces compliance.


OBJECTIVE
To evaluate the effectiveness of a new pre-combined aerosol formulation (salbutamol and nedocromil) in preventing exercise-induced bronchoconstriction and to compare it to salbutamol alone.


METHODS
Twelve children with asthma were studied in a double-blind, double-dummy, randomized, crossover, placebo-controlled design to compare the protective effect of salbutamol and a new pre-combined salbutamol/nedocromil formulation against exercise-induced bronchoconstriction. The drugs were delivered by a metered-dose inhaler (salbutamol, 200 microg; salbutamol/nedocromil, 200 microg/4 mg; placebo, 2 puffs) 20 minutes before exercise.


RESULTS
Both active drugs were significantly more protective than placebo but there was no difference between them. Complete protection was obtained in 12/12, 10/12, and 1/12 subjects for the salbutamol/nedocromil combination, salbutamol alone and placebo, respectively.


CONCLUSIONS
Although inhaled beta-agonists alone are highly efficacious in preventing exercise-induced bronchoconstriction, a minority of patients exists for whom a combined treatment with salbutamol and nedocromil is advantageous. This group may represent a subpopulation of subjects who release more, or different, mediators in response to exercise.
de Benedictis
F M
FM
Department of Pediatrics, University of Perugia, Italy.
Tuteri
G
G
Pazzelli
P
P
Solinas
L F
LF
Niccoli
A
A
Parente
C
C
D000293:Adolescent; D000318:Adrenergic beta-Agonists / Q000008:administration & dosage / Q000627:therapeutic use*; D000420:Albuterol / Q000008:administration & dosage / Q000627:therapeutic use*; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001250:Asthma, Exercise-Induced / Q000517:prevention & control*; D016084:Bronchoconstriction / Q000187:drug effects; D002648:Child; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D009330:Nebulizers and Vaporizers; D017835:Nedocromil / Q000008:administration & dosage / Q000627:therapeutic use*
D000318:Adrenergic beta-Agonists; D018927:Anti-Asthmatic Agents; D004338:Drug Combinations; D017835:Nedocromil; D000420:Albuterol