Evaluation of levalbuterol metered dose inhaler in pediatric patients with asthma: a double-blind, randomized, placebo- and active-controlled trial

Abstract

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.

A cumulative dose study of levalbuterol and racemic albuterol administered by hydrofluoroalkane-134a metered-dose inhaler in asthmatic subjects

“…These factors are not well understood but could relate to solution formulation, emitted MDI dose, particle size, or local absorption and metabolism differences. Consistent with prior reports 8,11,12 for subjects receiving racemic albuterol HFA, the (S)-albuterol plasma concentration reached at least a 4-fold higher level than the (R)-albuterol plasma concentration. These high levels of (S)-albuterol in the subjects administered racemic albuterol were not associated with impaired bronchodilatory response in this study.…”

“…4 FEV 1 values improved similarly for subjects administered levalbuterol HFA MDI and racemic albuterol HFA MDI over the cumulative dosing regimen, which is consistent with a report that evaluated the efficacy of these 2 therapies in asthmatic children aged 4 to 11 years. 8 A prior cumulative dose study comparing levalbuterol and racemic albuterol delivered by means of nebulization reported similar improvements in FEV 1 , changes in heart rate, and serum potassium concentration for the 2 treatments. 4 This previous study also reported a similar therapeutic ratio for the 2 treatments.…”

“…4,6,7 In a study in asthmatic children (4-11 years of age), levalbuterol HFA MDI (45 mg) and racemic albuterol HFA MDI (90 mg) had similar efficacy, although fewer total adverse events were observed in levalbuterol HFA MDI-treated subjects, including asthma exacerbations and respiratory adverse events. 8 In older subjects with asthma, possible treatment differences between the 2 preparations have not been well studied. This study compared the tolerability, airway function efficacy, and relative potency of cumulative single-day dosing with levalbuterol HFA MDI and racemic albuterol HFA MDI in subjects 12 years of age or older with asthma.…”

A Levalbuterol Therapeutic Misadventure

“…There have been rare reports concerning the use or abuse of levalbuterol (2). Two reports note that QT prolongation and hypokalemic effects of levalbuterol are similar to racemic albuterol (3,4).…”

Guidelines for Bystander First Aid 2016

“…For asthma and chronic bronchitis, proper use of inhaled bronchodilators can relieve shortness of breath and wheeze. They have been shown to be effective, (10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20) with a low incidence of adverse events. (10,(15)(16)(17) Therefore, fi rst aid providers should be familiar with the available inhaled bronchodilator and assist when a casualty with asthma or chronic bronchitis is experiencing an acute exacerbation of the condition.…”