Comparison of chest X-ray findings and other parameters in acute exacerbation of chronic bronchitis in Japan and the West

A. Watanabe, S. Kohno, Y. Niki, A. Saito

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    3 Citations (Scopus)

    Abstract

    One of the issues concerning harmonization in the development of pharmaceutical products, especially antimicrobials, is discrepancy in the indications to be studied clinically. In particular, it has been very much questioned whether the underlying disease in Western patients diagnosed with acute exacerbation of chronic bronchitis (AECB) is identical with chronic bronchitis in Japan. We assessed chest X-ray films from 105 AECB patients enrolled in a clinical study of SB265805 (a fluoroquinolone antibacterial agent under development) conducted in Europe, and then compared their clinical signs/symptoms and laboratory data with Japanese historical data. Five of the 105 patients did not meet the criteria of AECB; i.e., 2 of them were diagnosed with pneumonia, 1 with bronchiectasis, 1 with pneumoconiosis, and 1 with bronchiectasis plus pulmonary emphysema. In the remaining 100 patients, chest X-ray findings and laboratory test results were consistent with the concept of chronic bronchitis, although 23 of them had other cardiac or pulmonary diseases as well. There were significant imbalances in distribution between Western patients and Japanese historical data in terms of age, cough, WBC counts, and C-reactive protein (CRP) levels. Compared with Japanese historical data, Western patients were younger and had a more severe cough, although increases in WBC and CRP were less remarkable. For other variables, i,e., sex, fever, and volume of sputum, no significant difference was detected in distribution. Overall, there was no significant difference between the two groups in regard to disease severity, as assessed by fever, WBC, and CRP.

    Original languageEnglish
    Pages (from-to)37-44
    Number of pages8
    JournalJournal of Infection and Chemotherapy
    Volume7
    Issue number1
    DOIs
    Publication statusPublished - 2001

    Keywords

    • AECB
    • Antimicrobial drug
    • Chronic bronchitis
    • Clinical studies
    • ICH
    • X-ray diagnosis

    ASJC Scopus subject areas

    • Microbiology (medical)
    • Pharmacology (medical)
    • Infectious Diseases

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