Impact of racemic albuterol compared to levalbuterol on objective measures of hyperactivity and inattentiveness in children with asthma☆
Abstract
Rationale
Levalbuterol (LEV) 0.63 mg produces clinically comparable bronchodilation compared with racemic albuterol (RAC) 2.5 mg, but with fewer beta-mediated side effects. Parents complain of increases in hyperactivity and restlessness following treatment with racemic albuterol (White and Sander, JACI 1999). This study quantified and compared the effects of LEV, RAC, and placebo (PLA) on measures of hyperactivity and attentiveness in children with asthma.
Methods
Randomized, double-blind, 3-way crossover study. Either PLA, LEV 0.63 mg and RAC 2.5 mg were administered to 16 children (12 to 16 years old) on three separate visits. Attention and activity were measured using an FDA-approved test (McLean Motion and Attention Test) focused on two of the primary symptoms of ADHD, namely hyperactivity and inattention (15-min computer-driven vigilance task coupled to a high precision motion analysis system that tracks patient movement, performed at baseline and 15-min post drug administration). Objective measures included time spent immobile, spatial scaling (complexity of movement patterns), temporal scaling (index of time spent moving) and heart rate.
Results
Measures were significantly better following treatment with LEV compared with RAC (p≤0.007), indicating that RAC produced less time spent immobile, a higher index of time spent moving and more complex movements. Additionally, RAC resulted in significant changes in time spent immobile versus placebo (p=0.03). RAC, but not LEV, resulted in a significant increase in heart rate (p≤0.014 versus LEV and placebo).
Conclusions
In this study, treatment with RAC 2.5 mg significantly increased objective measures of hyperactivity and inattentiveness in asthmatic children compared with LEV 0.63 mg.
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ABSTRACT