Paper
Safety and Efficacy of a New Albuterol Hydrofluoroalkane Formulation for Treating Asthma Symptoms in Children Two to Less Than Four Years of Age
Published Jun 6, 2006 · K. Kim, M. Noonan, E. Kerwin
Applied Immunohistochemistry & Molecular Morphology
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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, perc...
RCTAlbuterol HFA is safe and effective for treating asthma symptoms in children aged 2 to less than 4 years, but not for children aged 4 years or older.
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