STUDY OBJECTIVE: An efficacy treatment study is conducted comparing levalbuterol to racemic albuterol for acute pediatric asthma in the emergency department (ED). METHODS: This was a prospective, double-blind, randomized, controlled study involving 129 children (2 to 14 years), presenting to a pediatric ED with an acute moderate or severe asthma exacerbation. Children were treated using a standard ED asthma pathway. Primary outcomes were changes from baseline in clinical asthma score and the percentage of predicted forced expiratory volume in 1 second after the first, third, and fifth treatment. Secondary outcomes included number of treatments, length of ED care, rate of hospitalization, and changes in pulse rate, respiratory rate, and oxygen saturation. Occurrence of adverse events was recorded. RESULTS:Sixty-four children in the racemic albuterol and 65 children in the levalbuterol group completed the study. There were no differences between groups in primary outcomes, secondary outcomes, or adverse events. CONCLUSION: There was no difference in clinical improvement in children with acute moderate to severe asthma exacerbations treated with eitherracemic albuterol or levalbuterol.
RCT Entities:
STUDY OBJECTIVE: An efficacy treatment study is conducted comparing levalbuterol to racemic albuterol for acute pediatric asthma in the emergency department (ED). METHODS: This was a prospective, double-blind, randomized, controlled study involving 129 children (2 to 14 years), presenting to a pediatric ED with an acute moderate or severe asthma exacerbation. Children were treated using a standard ED asthma pathway. Primary outcomes were changes from baseline in clinical asthma score and the percentage of predicted forced expiratory volume in 1 second after the first, third, and fifth treatment. Secondary outcomes included number of treatments, length of ED care, rate of hospitalization, and changes in pulse rate, respiratory rate, and oxygen saturation. Occurrence of adverse events was recorded. RESULTS: Sixty-four children in the racemic albuterol and 65 children in the levalbuterol group completed the study. There were no differences between groups in primary outcomes, secondary outcomes, or adverse events. CONCLUSION: There was no difference in clinical improvement in children with acute moderate to severe asthma exacerbations treated with either racemic albuterol or levalbuterol.