Dose-finding study on NM441 in chronic respiratory tract infections

• Published in: Japanese Journal of Chemotherapy Vol. 44; no. Supplement1; pp. 362 - 378
• Main Author: Kobayashi, Hiroyuki
• Format: Journal Article
• Language: Japanese
• Published: Japanese Society of Chemotherapy 1996; 公益社団法人 日本化学療法学会
• Subjects: chronic respiratory tract infection; dose-finding study; NM441; ofloxacin
• ISSN: 1340-7007; 1884-5886
• DOI: 10.11250/chemotherapy1995.44.Supplement1_362

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.