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  • Title: Fluticasone propionate 100 microg bid using a non-CFC propellant, HFA 134a, in asthmatic children.
    Author: Lyttle B, Gilles J, Panov M, Emeryk A, Wixon C.
    Journal: Can Respir J; 2003 Mar; 10(2):103-9. PubMed ID: 12687029.
    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 microg daily propelled by HFA 134a to FP 200 microg 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 microg/day or less of beclomethasone dipropionate, budesonide or flunisolide, or 250 microg/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. CONCLUSIONS: 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.
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