TY - JOUR
T1 - Pharmacodynamic study of procaterol hydrochloride dry powder inhaler
T2 - Evaluation of pharmacodynamic equivalence between procaterol hydrochloride dry powder inhaler and procaterol hydrochloride metered-dose inhaler in asthma patients in a randomized, double-dummy, double-blind crossover manner
AU - Kawai, Mitsura
AU - Sakai, A.
AU - Takaori, S.
AU - Hiura, A.
AU - Sakata, N.
AU - Nakashima, M.
AU - Miyamoto, T.
PY - 2005/7
Y1 - 2005/7
N2 - Therapeutic equivalence between procaterol hydrochloride dry powder inhaler (Meptin DPI) and procaterol hydrochloride metered-dose inhaler (Meptin MDI), the currently marketed formulation, was assessed in 16 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 μg of either Meptin DPI or Meptin MDI, and then crossed over in Period II after a washout interval of 3-28 days. Pharmacodynamic equivalence was accessed using AUC (FEV1)/h and peak FEV1 as indices, and the data were analyzed by analysis of variance (ANOVA). 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 -0.0995 to -0.0204 (L) for mean AUC (FEV1)/h and -0.102 to -0.022 (L) for mean peak FEV1, both within the acceptance criteria of -0.15 to 0.15 (L). Meptin DPI was therefore assessed as being equivalent to the current Meptin MDI.
AB - Therapeutic equivalence between procaterol hydrochloride dry powder inhaler (Meptin DPI) and procaterol hydrochloride metered-dose inhaler (Meptin MDI), the currently marketed formulation, was assessed in 16 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 μg of either Meptin DPI or Meptin MDI, and then crossed over in Period II after a washout interval of 3-28 days. Pharmacodynamic equivalence was accessed using AUC (FEV1)/h and peak FEV1 as indices, and the data were analyzed by analysis of variance (ANOVA). 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 -0.0995 to -0.0204 (L) for mean AUC (FEV1)/h and -0.102 to -0.022 (L) for mean peak FEV1, both within the acceptance criteria of -0.15 to 0.15 (L). Meptin DPI was therefore assessed as being equivalent to the current Meptin MDI.
KW - Bronchial asthma
KW - Dry powder inhaler
KW - Metered-dose inhaler
KW - Pharmacodynamic equivalence
KW - Procaterol hydrochloride
KW - β-Stimulant
UR - http://www.scopus.com/inward/record.url?scp=25844469493&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=25844469493&partnerID=8YFLogxK
U2 - 10.1358/mf.2005.27.6.896830
DO - 10.1358/mf.2005.27.6.896830
M3 - Article
C2 - 16179955
AN - SCOPUS:25844469493
VL - 27
SP - 385
EP - 389
JO - Methods and Findings in Experimental and Clinical Pharmacology
JF - Methods and Findings in Experimental and Clinical Pharmacology
SN - 0379-0355
IS - 6
ER -