Pharmacodynamic study of procaterol hydrochloride dry powder inhaler: 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

Mitsura Kawai, A. Sakai, S. Takaori, A. Hiura, N. Sakata, M. Nakashima, T. Miyamoto

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)385-389
Number of pages5
JournalMethods and Findings in Experimental and Clinical Pharmacology
Volume27
Issue number6
DOIs
Publication statusPublished - 2005 Jul

Keywords

  • Bronchial asthma
  • Dry powder inhaler
  • Metered-dose inhaler
  • Pharmacodynamic equivalence
  • Procaterol hydrochloride
  • β-Stimulant

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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