Pharmacodynamic equivalence study of CFC-free and CFC-containing procaterol hydrochloride metered-dose inhalers.
Equivalence between a CFC-free procaterol hydrochloride metered-dose inhaler using HFA-227 as a propellant (Meptin [HFA]) and a CFC-containing procaterol hydrochloride metered-dose inhaler (Meptin [CFC]) was assessed in 28 patients with bronchial asthma. The study was conducted in a randomized, double-dummy, double-blind crossover manner, using forced expiratory volume in the first second (FEV1) as an index of bronchodilatory effect. In Period I, the patients received 20 microg of either Meptin [HFA] or Meptin [CFC] and then crossed over in Period II after a washout interval of 3-28 days. Pharmacodynamic equivalence was assessed using AUC (FEV1)/h and peak FEV1 as indices, and the data was analyzed by analysis of variance. Factors used for the analysis were the treatment group and/or carryover effect, patients within each group, period, and treatment. The 90% confidence intervals for the differences between the two treatments were -0.0507 to 0.0039 (L) for mean AUC (FEV1)/h and -0.056 to 0.026 (L) for mean peak FEV1, both within the acceptance criteria of -0.15 to 0.15 (L). Meptin [HFA] was therefore assessed as being equivalent to the current Meptin [CFC].
Kawai
M
M
Department of Respiratory Disease, Kouseikai-Takaori Hospital Medical Corporation, Sakyo-ku, Kyoto, Japan. chest3@bb.excite.co.jp
Nakashima
M
M
Takaori
S
S
Nakamura
Y
Y
Akamatsu
K
K
Nakashima
M
M
Miyamoto
T
T
D000280:Administration, Inhalation; D000335:Aerosol Propellants / Q000008:administration & dosage / Q000494:pharmacology; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D017402:Chlorofluorocarbons / Q000493:pharmacokinetics; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D006845:Hydrocarbons, Fluorinated / Q000008:administration & dosage / Q000494:pharmacology; D008297:Male; D036501:Metered Dose Inhalers / Q000592:standards*; D008875:Middle Aged; D017265:Procaterol / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency; D005466:Fluorocarbons
D000335:Aerosol Propellants; D001993:Bronchodilator Agents; D017402:Chlorofluorocarbons; D006845:Hydrocarbons, Fluorinated; D017265:Procaterol; C094049:apaflurane; D005466:Fluorocarbons