Titre du document / Document title

Albuterol aerosol versus albuterol Rotacaps® in exercise-induced bronchospasm in children

Auteur(s) / Author(s)

BRONSKY E. A. ⁽¹⁾ ; SPECTOR S. L. ; PEARLMAN D. S. ; JUSTUS S. E. ; BISHOP A. L. ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ AAAA medical res. group, Salt Lake City UT 84102, ETATS-UNIS

Résumé / Abstract

The purpose of this study was to determine the safety and effectiveness of albuterol aerosol 180 μg and albuterol powder 200 μg in the prevention of exercise-induced bronchospasm in children. Forty-six patients aged 4-11 years with asthma and exercise-induced bronchospasm were enrolled in this randomized, double-blind, single-dose, three-way crossover study comparing albuterol aerosol, albuterol powder, and placebo. Exercise challenge was performed at the screening visit for qualifying and baseline determinations of pulmonary function and then 15 min after drug administration at each of three visits. Prevention of exercise-induced bronchospasm was assessed by comparing across all treatment groups the percentage change in FEV₁ from pre- to postexercise, the percentage of patients protected by treatment, postexercise minimum FEV₁, and postexercise change in FEV₁. Safety was assessed by observation of clinical adverse events, laboratory tests, physical examination, electrocardiogram and rhythm strips, vital signs, and pulmonary auscultation. Forty-four patients completed the study. Mean postexercise FEV₁ decreased 6% from preexercise values when patients were treated with either albuterol formulation ; FEV₁ decreased 23% when patients were treated with placebo. Exercise-induced bronchospasm was prevented in 95% of patients when treated with albuterol powder, in 91% treated with albuterol aerosol, and in 57% treated with placebo. Patients maintained significantly higher mean minimum FEV₁ values after treatment with albuterol powder and albuterol aerosol than when treated with placebo. Treatment with either albuterol formulation produced a significantly smaller decrease in mean FEV₁ from pre- to postexercise than treatment with placebo. No drug-related adverse events were reported, and safety assessments were within normal limits. Albuterol aerosol (180 μg) and the powder formulation, albuterol Rotacaps® (200 μg), are equally safe and effective in protecting against exercise-induced bronchospasm in children aged 4-11 years. When given albuterol, fewer than 10% of patients had a greater than 20% decrease in FEV₁ as compared with 43% when given placebo. All safety assessments indicated that both albuterol formulations were well tolerated by all children.

Revue / Journal Title

The Journal of asthma   ISSN 0277-0903   CODEN JOUADU 

Source / Source

1995, vol. 32, n^o3, pp. 207-214 (19 ref.)

Langue / Language

Anglais

Editeur / Publisher

Informa Healthcare, New York, NY, ETATS-UNIS  (1981) (Revue)

Mots-clés anglais / English Keywords

Asthma ; Physical exercise ; β-Adrenergic receptor agonist ; β2-Adrenergic receptor ; Inhalation ; Aerosols ; Powder ; Comparative study ; Treatment ; Treatment efficiency ; Child ; Double blind study ; Human ; Respiratory disease ; Bronchodilator ; Chemotherapy ;

Mots-clés français / French Keywords

Asthme ; Exercice physique ; Stimulant β-adrénergique ; Récepteur β2-adrénergique ; Inhalation ; Aérosol ; Poudre ; Etude comparative ; Traitement ; Efficacité traitement ; Enfant ; Etude double insu ; Homme ; Appareil respiratoire pathologie ; Bronchodilatateur ; Chimiothérapie ;

Mots-clés espagnols / Spanish Keywords

Asma ; Ejercicio físico ; Estimulante β-adrenérgico ; Receptor β2-adrenérgico ; Inhalación ; Aerosol ; Polvo ; Estudio comparativo ; Tratamiento ; Eficacia tratamiento ; Niño ; Estudio doble ciego ; Hombre ; Aparato respiratorio patología ; Broncodilatador ; Quimioterapia ;

Localisation / Location

INIST-CNRS, Cote INIST : 13894, 35400005090353.0050