Equivalence of asthma control with new CFC-free formulation HFA-134a beclomethasone dipropionate and CFC-beclomethasone dipropionate.
The study was designed to test for equivalence of asthma control between a new aerosol formulation of beclomethasone dipropionate (BDP) incorporating a chlorofluorocarbon-(CFC) free, hydrofluoroalkane propellant (HFA-134a) and the conventional beclomethasone aerosol formulated in CFC propellants. Sixty-eight asthmatic patients entered an eight-week, randomised, double-blind crossover study. All patients, previously stabilised on BDP, were randomised to receive the same dose of BDP from each of the study treatments. Statistically significant equivalence was demonstrated between HFA-BDP and CFC-BDP for asthma control parameters: FEV1, morning and evening PEF, sleep disturbance, wheeze and cough, morning breathlessness and bronchodilator use. Such equivalence was also demonstrated for safety parameters. To conclude, it has been demonstrated that HFA-BDP achieves a level of asthma control that is clinically and statistically equivalent to CFC-BDP in terms of efficacy and safety, at total daily doses ranging from 200 micrograms to 600 micrograms in asthma patients previously stabilised on inhaled CFC-BDP.
Dahl
R
R
Aarhus Kommunehospital, Denmark.
Ringdal
N
N
Ward
S M
SM
Stampone
P
P
Donnell
D
D
D000293:Adolescent; D000335:Aerosol Propellants / Q000627:therapeutic use*; D000704:Analysis of Variance; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D001507:Beclomethasone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017402:Chlorofluorocarbons / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006845:Hydrocarbons, Fluorinated; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D013810:Therapeutic Equivalency; D005466:Fluorocarbons
D000335:Aerosol Propellants; D018927:Anti-Asthmatic Agents; D001507:Beclomethasone; D017402:Chlorofluorocarbons; D006845:Hydrocarbons, Fluorinated; C094049:apaflurane; D005466:Fluorocarbons