Abstract 21

Objective: To determine whether the addition of inhaled ipratropium bromide (IB), to inhaled salbutamol, and systemic corticosteroid(CS) therapy is more efficacious than inhaled salbutamol and systemic CS alone in the inpatient management of children with asthma.

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

Subjects: Children (1-18 years), admitted with an acute exacerbation of asthma, to a tertiary care paediatric hospital.

Intervention: Eighty children were randomised to receive either nebulised IB, 250 µg/dose (n=41), or nebulised normal saline, 1 ml/dose(n=39). All received nebulised salbutamol and systemic CS.

Main Outcome Measures: The primary outcome variable was a validated clinical asthma score (CAS), measured at baseline and every 6 hours for 36 hours. Secondary outcomes included FEV1 in children > 5 years, oxygen (O2) saturation, time to an inhaled drug dosing interval of 4 hours, and length of hospital stay (LOS).

Results: There were no differences between groups on baseline characteristics. There were no differences between groups in the CAS over time (repeated measures ANOVA p=0.07). There were no differences between groups in FEV1 over time (p=0.76). There were no differences (IB vs. placebo) in the secondary outcomes: O2 saturation (p=0.90), mean time (hours) to a drug dosing interval of 4 hours (28.6 vs. 28.3, p=0.95), and mean LOS (hours)(48.5 vs. 43.3, p=0.36).

Conclusion: The results of this study do not support the addition of nebulised IB to nebulised salbutamol and systemic CS therapy in children who are admitted to hospital.