Elsevier

The Journal of Pediatrics

Volume 143, Issue 6, December 2003, Pages 731-736
The Journal of Pediatrics

Comparison of racemic albuterol and levalbuterol for treatment of acute asthma☆

https://doi.org/10.1067/S0022-3476(03)00493-1Get rights and content

Abstract

Objective

To determine whether levalbuterol resulted in fewer hospital admissions than racemic albuterol when used for treatment of acute asthma.

Study design

A randomized, double-blind, controlled trial was conducted in the emergency department (ED) and inpatient asthma care unit of an urban tertiary children's hospital. Children age 1 to 18 years (n = 482) provided a total of 547 enrollments. Patients received a nebulized solution of either 2.5 mg racemic albuterol or 1.25 mg levalbuterol every 20 minutes (maximum six doses). Patients admitted to the asthma care unit were treated in a standardized fashion by using the same blinded drug assigned in the ED. Hospitalization rate was the primary outcome.

Results

Hospitalization rate was significantly lower in the levalbuterol group (36%) than in the racemic albuterol group (45 %, P = .02). The adjusted relative risk of admission in the racemic group compared with the levalbuterol group was 1.25 (95% confidence interval, 1.01-1.57). Hospital length of stay was not significantly shorter in the levalbuterol group (levalbuterol, 44.9 hours; racemic albuterol, 50.3 hours; P = .63). No significant adverse events occurred in either group.

Conclusions

Substituting levalbuterol for racemic albuterol in the ED management of acute asthma significantly reduced the number of hospitalizations.

Section snippets

Study population

All children between 1 and 18 years of age with physician-diagnosed asthma presenting to the Pediatric Emergency Department (ED) of Rainbow Babies and Children's Hospital, a university-affiliated tertiary care children's hospital in Cleveland, Ohio, between April 2000 and December 2000 for treatment of acute asthma were eligible for study enrollment. Patients were not eligible if they were experiencing a first episode of wheezing, were not currently being treated for asthma, were pregnant, had

Results

A total of 552 enrollments from 482 children were randomized between April 2000 and December 2000; five subjects had other chronic disease and were excluded from all analyses. Another 552 children were missed by recruiters or were determined to have a questionable diagnosis of asthma. The final analyses used 547 enrollments: 278 enrollments in the levalbuterol group and 269 in the racemic albuterol group; children who were repeat enrollments were equally distributed between the treatment

Discussion

Until recently, optically pure isomers of β-agonists were not available or were not thought necessary for optimum clinical safety or efficacy in acute asthma treatment. The availability of purified (R)-albuterol (levalbuterol) and the Food and Drug Administration's position to quantify the safety of racemic drugs have generated renewed interest in the role of inert isomers. In vitro cellular data implicate (S)-albuterol as a possible cause of airway hyperreactivity, bronchoconstriction, or

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    ☆

    Supported by an unrestricted research grant from Sepracor, Marlborough, Massachusetts. The study design, conduct, interpretation, and analysis of data were conducted solely by the investigators. Sepracor supplied racemic albuterol and levalbuterol. Salter (Irvine, Calif) supplied Nebutech nebulizers. Dr Carl, Dr Kercsmar, and Mr Myers have received honoraria for speaking engagements provided by Sepracor in the form of unrestricted educational grants.

    Portions of this work were presented at the Annual Meeting of the American Academy of Pediatrics, San Francisco, California, October 2001.

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