Abstract
BACKGROUND: Secondary to phasing out chlorofluorocarbons (CFCs), the fluticasone propionate (FP) pressurized metered-dose inhaler has been formulated in a nonozone-depleting propellant, hydrofluoralkane (HFA) 134a.OBJECTIVES: To demonstrate equivalent efficacy and safety of FP 200 µg daily propelled by HFA 134a to FP 200 µg daily propelled by CFCs 11 and 12 over a four-week treatment period in pediatric asthmatic patients.METHODS: The study was multinational, randomized, double blind and of parallel group design. Eligible patients aged 16 years and younger were steroid naive or receiving 500 µg/day or less of beclomethasone dipropionate, budesonide or flunisolide, or 250 µg/day or less of inhaled FP. The primary efficacy variable was mean morning peak expiratory flow with equivalence determined if the 90% CIs for the treatment differences between groups were within ±15 L/min.RESULTS: Three hundred fifteen patients (mean age 9.3±2.8 years) were randomly assigned; 158 patients received FP HFA 134a and 157 patients received FP CFC. Over the four-week treatment period, mean morning peak expiratory flow increased from baseline in both groups (14 L/min and 17 L/min, respectively), with a mean treatment difference of -2 L/min. Equivalence was demonstrated between the groups (90% CI -6 to +3 L/min; P=0.589). Both formulations were well tolerated with no serious drug-related events.CCONCLUSIONS: FP propelled by HFA 134a has equivalent efficacy and comparable safety to FP propelled by CFC propellants at a microgram equivalent dose in pediatric asthmatic patients.