Fluticasone propionate 100 microg bid using a non-CFC propellant, HFA 134a, in asthmatic children.
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.


OBJECTIVE
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.
Lyttle
Brian
B
Department of Paediatrics, Children's Hospital of Western Ontario, London, Canada.
Gilles
John
J
Panov
Maarja
M
Emeryk
Andrzej
A
Wixon
Claire
C
D000280:Administration, Inhalation; D000293:Adolescent; D000730:Androstadienes / Q000008:administration & dosage*; D001249:Asthma / Q000175:diagnosis / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D000068298:Fluticasone; D005500:Follow-Up Studies; D005541:Forced Expiratory Volume; D006801:Humans; D006845:Hydrocarbons, Fluorinated / Q000008:administration & dosage*; D008297:Male; D009330:Nebulizers and Vaporizers; D011336:Probability; D012129:Respiratory Function Tests; D012720:Severity of Illness Index; D016896:Treatment Outcome; D005466:Fluorocarbons
D000730:Androstadienes; D000068298:Fluticasone; D006845:Hydrocarbons, Fluorinated; C094049:apaflurane; D005466:Fluorocarbons