Evaluation of the Safety and Efficacy of Levalbuterol in 2-5-year-Old Patients with Asthma

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  • FGfor the Xopenex® Pediatric Study Group
    for the Xopenex® Pediatric Study Group
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Abstract
The purpose of this study was to evaluate the safety and efficacy of single‐isomer (R)‐albuterol (levalbuterol, LEV) in children aged 2–5 years. Children aged 2–5 years (n = 211) participated in this multicenter, randomized, double‐blind study of 21 days of t.i.d. LEV (0.31 mg or 0.63 mg without regard to weight), racemic albuterol (RAC, 1.25 mg for children P = NS). In the subset of subjects able to perform PEF (51.7%), all active treatments improved in‐clinic PEF after the first dose (mean ± SD: PBO, 1.4 ± 20.8; LEV 0.31 mg, 12.4 ± 12; LEV 0.63 mg, 16.7 ± 15.4; RAC, 18.0 ± 16.5 l/min; P < 0.01). PACQLQ measurements improved more than the minimally important difference only in the LEV‐treated groups, and were significant in children P < 0.05). Asthma exacerbations occurred primarily in children ≥33 lb, and one serious asthma exacerbation occurred in the 2.5‐mg RAC group. RAC and LEV 0.63 mg, but not LEV 0.31 mg or placebo, led to significant increases in ventricular heart rate. In this study of levalbuterol in children aged 2–5 years with asthma, LEV was generally well‐tolerated, and in children able to perform PEF, led to significant bronchodilation compared with placebo. Pediatr Pulmonol.

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