Randomized trial of the addition of ipratropium bromide to albuterol and corticosteroid therapy in children hospitalized because of an acute asthma exacerbation.

Objective: To determine whether the addition of inhaled ipratropium bromide to inhaled albuterol and systemic corticosteroid therapy was more efficacious than inhaled albuterol and systemic corticosteroids alone in the inpatient treatment of acute asthma exacerbations in children.

Design: Double-blind, randomized, placebo-controlled trial.

Setting: Pediatric inpatient unit of a tertiary urban hospital.

Participants: Eighty children (aged 1-18 years) hospitalized because of an acute asthma exacerbation.

Intervention: Children were randomized to receive either nebulized ipratropium bromide, 250 microg, or nebulized isotonic sodium chloride solution, 1 mL. All children received albuterol and systemic corticosteroids.

Main Outcome Measures: The primary outcome variable was a validated clinical asthma score, measured at baseline and every 6 hours for 36 hours. Secondary outcome measures included the forced expiratory volume in 1 second, the oxygen saturation, the number of doses of inhaled study drug, the time to an inhaled drug-dosing interval of 4 hours, and the length of the hospital stay.

Results: There were no differences between groups on baseline characteristics. The intention-to-treat analysis, using repeated-measures analysis of variance, showed no significant (P =.07) difference between the groups in the clinical asthma score over time. There were also no significant differences between groups on secondary outcomes.

Conclusion: The addition of nebulized ipratropium bromide to nebulized beta(2)-agonist and corticosteroid therapy in the treatment of children hospitalized because of asthma (following intensive emergency department treatment) confers no extra benefit.