High-Dose Continuous Nebulized Levalbuterol for Pediatric Status Asthmaticus: A Randomized Trial
Objective
To assess the use of high-dose continuous levalbuterol (LEV), the single active (R)-enantiomer of racemic albuterol (RAC), in the treatment of status asthmaticus.
Study design
Children age 6 to 18 years with severe asthma exacerbation were enrolled in this randomized, double-blind trial if they failed initial emergency department (ED) therapy with RAC and systemic steroids. Subjects received equipotent doses of RAC (20 mg/hour) or LEV (10 mg/hour) within a standardized inpatient protocol. Blood samples for measurements of albuterol enantiomer, potassium, and glucose levels were obtained from the first 40 subjects. The median time until discontinuation of continuous therapy was compared using the rank-sum test, and other outcomes were compared using general linear mixed models.
Results
A total of 81 subjects (40 in the RAC group and 41 in the LEV group) were enrolled; the 2 groups were similar at baseline. Both groups tolerated continuous therapy with similar changes in heart rate and serum potassium and glucose levels but higher serum (S)-albuterol concentrations in the subjects treated with RAC. The median time for continuous therapy was similar in the RAC and LEV groups (18.3 hours vs 16.0 hours), as were the other clinical measures.
Conclusions
Substituting high-dose continuous LEV for RAC did not reduce the time on continuous therapy and had similar adverse effects in children who had failed initial treatment with RAC.
ED, Emergency department, FEV1, Forced expiratory volume in 1 second, LEV, Levalbuterol, NAEPP, National Asthma Education and Prevention Program, RAC, Racemic albuterol
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This investigator-initiated study was funded by an unrestricted research grant from Sepracor Inc. The authors declare no other affiliation, financial agreements, or involvement with this or any company that might be considered a conflict of interest.
ClinicalTrials.gov registration number: NCT00124176.
PII: S0022-3476(09)00113-9
doi:10.1016/j.jpeds.2009.01.073
© 2009 Mosby, Inc. All rights reserved.
Refers to article:
- Love it or Lev it: Levalbuterol for Severe Acute Asthma—for Now, Leave It
