Dose-finding study on NM441 in chronic respiratory tract infections

H. Kobayashi, S. Kawai, S. Sakayori, A. Saito, M. Tomizawa, Y. Hiraga, M. Ohmichi, A. Watanabe, H. Takahashi, H. Kikuchi, T. Nukiwa, K. Sato, O. Sakai, K. Shiba, M. Yoshida, H. Maezawa, T. Okamura, H. Tanimoto, K. Obara

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    3 Citations (Scopus)

    Abstract

    A dose finding study on NM441, a novel new quinolone antimicrobial agent, for the patients with chronic respiratory tract infections was conducted with comparison to ofloxacin (OFLX). The daily dose of each drug was 400mg of NM441 given in 2 divided dosage (Group L), 600mg of NM441 given in 2 divided dosage (Group H) and 600mg of OFLX given in 3 divided dosage (Group C). The results obtained in this study were as follows. 1) Ninety one patients were enrolled in the study. Eighty two cases were evaluable for clinical efficacy. The clinical efficacy rates were 84.6% in Group L, 89.3% in Group H and 96.4% in Group C. 2) The bacterial eradication rates were 81.8% in Group L, 90.9% in Group H and 100% in Group C. 3) Side effects were seen in 3.6% of cases in Group L, 10.3% of cases in Group H and 0% of cases in Group C. Laboratory abnormal findings were observed in 16.7% of cases in Group L, 0% of cases in Group H and 14.8% of cases in Group C. Neither severe side effect nor laboratory abnormality was seen. 4) The usefulness rates were 81.5% in Group L, 82.8% in Group H and 96.4% in Group C. In all evaluation items described above, there were no significant differences between the 3 groups. The evidence indicates that a daily dosage of 600mg of NM441 would be considered an optimal clinical dosage for the treatment of the patients with chronic respiratory tract infections, including intractable cases.

    Original languageEnglish
    Pages (from-to)362-378
    Number of pages17
    JournalJapanese Journal of Chemotherapy
    Volume44
    Issue numberSUPPL. 1
    Publication statusPublished - 1996

    Keywords

    • NM441
    • chronic respiratory tract infection
    • dose finding study
    • ofloxacin

    ASJC Scopus subject areas

    • Pharmacology
    • Pharmacology (medical)

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