Reformulated fluticasone propionate hydofluoralkane inhalation aerosol is safe in pre-school children with asthma

Abstract

Following the withdrawal of metered-dose inhalers containing CFC as a propellant, many have been reformulated. A study of reformulated fluticasone propionate using hydofluoralkane (HFA) as a propellant is published in this issue of The Journal. Fluticasone HFA was compared to a placebo using a metered dose inhaler attached to a spacer with a face mask. The study was performed in children with asthma aged 1-4 years; there has been a lack of safety data in this age group. The study was requested by the US FDA to fulfill the requirements of the Pediatric Research Equity Act. Results show that the new formulation is safe. There was a statistically significant improvement in 24 hour daily asthma symptom scores and nighttime symptom scores over the entire treatment period versus the placebo group. Surprisingly, the effects on the day time asthma symptom scores were small. There were no clinically significant systemic effects as measured by a 12-hour overnight urine cortisol level. It is reassuring to note that the new formulation of fluticasone is safe in the preschool age group.