Authors: Berger, William E.¹; Milgrom, Henry²; Skoner, David P.³; Tripp, Kenneth⁴; Parsey, Merdad V.⁴; Baumgartner, Rudolf A.⁴; The Xopenex Pediatric Asthma Group,

Source: Current Medical Research and Opinion, Volume 22, Number 6, June 2006 , pp. 1217-1226(10)

Publisher: Informa Healthcare

Abstract:

Objective: To evaluate the efficacy and safety of levalbuterol metered dose inhaler (MDI) in children aged 4-11 years (n = 173).

Research design and methods: Multicenter, randomized, double-blind 28-day study of QID levalbuterol 90 μg, racemic albuterol 180 μg, and placebo (2:1:1 ratio). Serial spirometry was performed on Days 0, 14, and 28. The primary endpoint was the double-blind average peak percent (%) change in FEV₁ from visit pre-dose; the primary comparison was with placebo. Secondary endpoints included the area under the FEV₁ percent change from pre-dose curve and peak % predicted FEV₁. Safety endpoints included adverse events, laboratory tests, rescue medication use, and electrocardiograms.

Results: Levalbuterol significantly improved the least square mean peak percent change in FEV₁ compared with placebo (levalbuterol 25.6% ± 1.3% [p < 0.001]; racemic albuterol 21.8% ± 1.8% [p = ns]; placebo 16.8% ± 1.9%). Results for levalbuterol were similar for the other spirometry endpoints (p < 0.05 vs. placebo). No levalbuterol-treated patients had a peak percent change in FEV₁ < 10% (compared with 15.8% of racemic albuterol-treated patients and 30.3% of placebo-treated patients). The incidence of adverse events was 43.4% for levalbuterol, 56.4% for racemic albuterol, and 51.4% for placebo. The rate of discontinuation was 1.3% for levalbuterol, 2.6% for racemic albuterol, and 8.6% for placebo. The rate of asthma attacks (10.5%, 12.8%, 14.3%, respectively) was similar among treatments. Levalbuterol and racemic albuterol both reduced rescue medication use (p < 0.01 vs. placebo) and produced changes in ventricular heart rate and QT_c-F that were similar to placebo.

Conclusions: In this study, levalbuterol administered via MDI significantly improved airway function in comparison with placebo in asthmatic children aged 4-11 years with a safety profile that was similar to placebo.

Keywords: BETA2-AGONISTS; ALBUTEROL; BRONCHODILATOR; HYDROFLUORALKANE; LEVALBUTEROL; METERED DOSE INHALER; PEDIATRIC ASTHMA

Document Type: Research article

DOI: http://dx.doi.org/10.1185/030079906X112534

Affiliations: 1: Allergy & Asthma Associates of Southern California, Mission Viejo, CA, USA 2: University of Colorado Health Sciences Center, Denver, CO, USA 3: Allegheny General Hospital, Division of Allergy, Asthma and Immunology, Pittsburgh, PA, USA 4: Sepracor Inc., Marlborough, MA, USA

Publication date: 2006-06-01

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