Efficacy of racemic albuterol versus levalbuterol used as a continuous nebulization for the treatment of acute asthma exacerbations: a randomized, double-blind, clinical trial.
Author(s): Wilkinson M, Bulloch B, Garcia-Filion P, Keahey L
Affiliation(s): Department of Emergency Medicine, Dell Children's Medical Center of Central Texas, Austin, TX, USA.
Publication date & source: 2011-03, J Asthma., 48(2):188-93. Epub 2011 Jan 29.
Publication type: Comparative Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
OBJECTIVE: To compare racemic albuterol (RAC) with levalbuterol (LEV) in continuous form for the treatment of acute pediatric asthma exacerbations in the emergency department. STUDY DESIGN: Children between the ages of 6 and 17 inclusive were enrolled if they had a history of asthma, presented to the emergency department with an acute asthma exacerbation, and had an initial forced expiratory volume in 1 second (FEV1) <70% predicted. Patients were then randomized to receive either 7.5 mg of RAC or 3.75 mg of LEV over 1 hour, in addition to standard asthma therapies. Spirometry and asthma scoring were performed at the end of the first hour, and a second hour-long nebulization with the same drug was administered if deemed necessary. Spirometry and asthma scoring were again performed and the final disposition was recorded. As a second, optional part of the study, baseline serum albuterol levels were collected on some patients before treatment. RESULTS: A total of 99 patients completed the study (44 RAC and 55 LEV). Baseline characteristics were similar except that the RAC group had a higher baseline asthma score. Children in the RAC group had a greater improvement in their FEV1 (p = .043) as well as in their asthma scores (p = .01) after 1 hour of continuous treatment compared to the LEV group. The greater improvement in asthma scores was maintained after the second hour of continuous therapy in the RAC group (p = .008) but not for FEV1 measurements (p = .57). There were no differences between groups for changes in heart rate, respiratory rate, oxygen saturation, or rates of admission. CONCLUSIONS: At the doses used, RAC appears to be superior to LEV with respect to changes in FEV1 and asthma score. There was no significant difference between the drugs with respect to admission rates or side-effect profile.