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Canadian Respiratory Journal
Volume 10 (2003), Issue 2, Pages 103-109
http://dx.doi.org/10.1155/2003/627531
Original Article

Fluticasone Propionate, 100 µg bid, Using a Non-CFC Propellant, HFA 134a, in Asthmatic Children

Brian Lyttle,1 John Gillies,2 Maarja Panov,3 Andrzej Emeryk,4 and Claire Wixon5

1Department of Paediatrics, Children’s Hospital of Western Ontario, London, Ontario, Canada
2Anglesea Clinic, Hamilton, New Zealand
3Department of Paediatrics, Tartu University Children’s Hospital, Tartu, Estonia
4Department of Paediatrics, Szpital Dzieciecy, Lublin, Poland
5Respiratory Clinical Development and Product Strategy, GlaxoSmithKline Research and Development, Greenford, Middlesex, UK

Copyright © 2003 Hindawi Publishing Corporation. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.