Nebulized budesonide added to standard pediatric emergency department treatment of acute asthma: a randomized, double-blind trial

Abstract

Objectives: The goal was to determine if adding inhaled budesonide to standard asthma therapy improves outcomes of pediatric patients presenting to the emergency department (ED) with acute asthma.

Methods: The authors conducted a randomized, double-blind, placebo-controlled trial in a tertiary care, urban pediatric ED. Patients 2 to 18 years of age with moderate to severe acute asthma were randomized to receive either a single 2-mg dose of budesonide inhalation suspension (BUD) or normal sterile saline (NSS) placebo, added to albuterol, ipratropium bromide (IB), and systemic corticosteroids (SCS). The primary outcome was the difference in median asthma scores between treatment groups at 2 hours. Secondary outcomes included differences in vital signs and hospitalization rates.

Results: A total of 180 patients were enrolled. Treatment groups had similar baseline demographics, asthma scores, and vital signs. A total of 169 patients (88 BUD, 81 NSS) were assessed for the primary outcome. No significant difference was found between groups in the change in median asthma score at 2 hours (BUD -3, NSS -3, p = 0.64). Vital signs at 2 hours were also similar between groups. Fifty-six children (62%) were admitted to the hospital in the BUD group and 55 (62%) in the NSS group (difference 0%, 95% confidence interval [CI] = -14% to 14%). Neither multivariate adjustment nor planned subgroup analysis by inhaled corticosteroids (ICS) use prior to the ED significantly altered the results.

Conclusions: For children 2 to 18 years of age treated in the ED for acute asthma, a single 2-mg dose of budesonide added to standard therapy did not improve asthma severity scores or other short-term ED-based outcomes.