Safety and Efficacy of a New Albuterol Hydrofluoroalkane Formulation for Treating Asthma Symptoms in Children Two to Less Than Four Years of Age

Abstract

Metered dose inhalers (MDIs) are being reformulated with hydrofluoroalkane (HFA) propellants because of the ozone-depleting effects of chlorofluorocarbons. Although currently indicated for children 4 years of age or older, albuterol (Ventolin^®; GlaxoSmithKline, Research Triangle Park, NC) HFA is sometimes used to treat younger children. Therefore, its safety in children aged 2 to less than 4 years was determined in this randomized, doubleblinded, multicenter parallel-group study. Seventy-seven children with asthma received albuterol HFA 90 or 180 µg or placebo three times daily for 4 weeks via MDI with one of two holding chambers and a face mask. Because of the small sample size, the study was not powered to achieve statistically significant outcomes. Improvements in 24-hour and nighttime asthma symptom scores were not significantly different between groups. Compared to placebo, albuterol HFA groups had greater improvements in daytime asthma symptom scores, rescue albuterol use, nighttime awakenings, percent symptom-free days, and twice daily peak expiratory flow although these differences did not reach statistical significance. Adverse events were less frequent in albuterol HFA 90 µg (35% or 9 subjects) than in albuterol HFA 180 µg (52% or 13 subjects) and placebo (42% or 11 subjects). Frequently reported adverse events included pyrexia (placebo and albuterol HFA 90 µg:8% [2 subjects each]; albuterol HFA 180 µg:4% [1 subject]), vomiting (placebo: 8% [2 subjects]; albuterol HFA 90 µg:4% [1 subject]) and diarrhea (albuterol HFA 180 mcg:8% [2 subjects]). QT prolongation occurred in 4 subjects, 3 subjects in the albuterol HFA 180 µg and 1 subject in the albuterol HFA 90 µg group. Mild tremor occurred in 12% (3 subjects in albuterol HFA 90 µg), 8% (2 subjects in albuterol HFA 180 µg), and 4% (1 subject in placebo) of patients.