title: Therapeutic equivalence of inhaled beclomethasone dipropionate with CFC and non-CFC (HFA 134a) propellants both delivered via the Easibreathe inhaler for the treatment of paediatric asthma.
abstract: Chlorofluorocarbon (CFC)-containing inhalers for use in the treatment of asthma are to be phased out under the terms of the Montreal Protocol (1). In this multi-centre, randomized, double-blind study, the therapeutic equivalence of two formulations of beclomethasone dipropionate (BDP) containing CFC or non-CFC (HFA134a) propellant, both delivered via the Easibreathe (Norton Healthcare Ltd, London, U.K.) inhaler, was determined in 229 asthmatic children. Each child received 100 microg doses of BDP (containing either CFC or HFA propellant) twice daily for 12 weeks. Both CFC and HFA formulations produced statistically and clinically significant improvements in patient's lung function and symptom scores when administered via the Easibreathe inhaler. The improvements in mean morning peak expiratory flow (PEF) were 41 l min(-1) and 34 l min(-1) for the BDP-HFA and BDP-CFC products respectively (P<0.001) and for mean evening PEF the improvements were 38 l min(-1) and 38 l min(-1), respectively (P<0.001). Similar findings were demonstrated for the other efficacy parameters. The two formulations were statistically equivalent with respect to efficacy. For mean morning PEF the estimated treatment difference (BDP-CFC/BDP-HFA ratio) was 102.6% (95% CI 99.1, 106.2). Similar equivalence was shown for the other efficacy parameters. Both products were well tolerated, with no difference in the adverse event profiles, effects on 24 h urinary cortisol or Candida colonisation. This study demonstrates that the new formulation of BDP with HFA-134a propellant is equivalent to and directly substitutable for BDP with the older CFC propellant in a dose for dose manner. This should enable a seamless transition from one product to the other when CFC containing products are eventually phased out. In addition this study has also shown that the Easibreathe inhaler is an effective delivery system for use with inhaled products for the treatment of asthma in children.
authors.affiliation: Ashford Surgery, Middlesex, UK.
authors.forename: I S
authors.initials: IS
authors.lastname: Farmer
authors.forename: M
authors.initials: M
authors.lastname: Middle
authors.forename: J
authors.initials: J
authors.lastname: Savic
authors.forename: V L
authors.initials: VL
authors.lastname: Perri
authors.forename: M J
authors.initials: MJ
authors.lastname: Herdman
mesh_terms: D000335:Aerosol Propellants / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D001249:Asthma / Q000188:drug therapy* / Q000652:urine; D001507:Beclomethasone / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D002648:Child; D017402:Chlorofluorocarbons / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006845:Hydrocarbons, Fluorinated / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D006854:Hydrocortisone / Q000652:urine; D008297:Male; D009330:Nebulizers and Vaporizers; D013810:Therapeutic Equivalency; D016896:Treatment Outcome; D005466:Fluorocarbons
chemical_list: D000335:Aerosol Propellants; D018927:Anti-Asthmatic Agents; D001507:Beclomethasone; D017402:Chlorofluorocarbons; D006845:Hydrocarbons, Fluorinated; D006854:Hydrocortisone; C094049:apaflurane; D005466:Fluorocarbons