Phase III Open Clinical Study and Long-Term Administration Study of SS320A in Patients Chronic Respiratory Diseases.
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Accession number;02A0208996
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| Title;Phase III Open Clinical Study and Long-Term Administration Study of SS320A in Patients Chronic Respiratory Diseases. |
| Author;
NAGAOKA SHIGERU
(Japan Res. Inst. Sputum)
TAKISHIMA TAMOTSU
(Tohoku Univ.)
NAGANO HITOSHI
(National Sanatorium Minami Fukuoka Hospital)
KAWAKAMI YOSHIKAZU
(Hokudai I Byoin Daiichinaika)
KITAMURA SATOSHI
(Jichiidai Byoin Kokyukinaika)
KAWAKAMI MASAHIKO
(Tokyotohiroobyoin Kokyukika)
OGURA TAKESHI
(National Sanatorium Toneyama Hospital)
SASAKI TAKAO
(Tottoridai I Byoin Daisannaika)
OGAWA NOBUYA
(Ehime Univ.)
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Journal Title;Journal of Clinical Therapeutics & Medicines
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Journal Code:Y0906A
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ISSN:0910-8211
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VOL.18;NO.1;PAGE.141-180(2002)
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| Figure&Table&Reference;FIG.3, TBL.40, REF.16 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;The efficacy, safety, and usefulness of SS320A, a mucoactive agent, in treating a variety of chronic respiratory diseases were examined in an open clinical study and a long-term study. 1) Total number of the subjects was 165. Of the 165 subjects, 76 had completed the open clinical study. They gave consent to participate in the long-term study 4 weeks after the start of administration of the test drug, and 89 registered the study. The number of analytical subjects for final global improvement was 57 in the open study and 74 in the long-term study; the number of analytical subjects for final safety was 73 in the open study and 82 in the long-term study; and that for final usefulness was 59 in the open study and 74 in the long-term study. 2) Main diseases of the analytical patients for final global improvement in the open study and long-term study included chronic bronchitis of 16% (9/57) and 24% (18/74), bronchiectasia of 9% (5/57) and 14% (10/74), pulmonary emphysema of 19% (11/57) and 20% (15/74), atypical mycobacterial disease of 5% (3/57) and 0% (0/0), pulmonary tuberculosis of 11% (6/57) and 9% (7/74), coniosis of 12% (7/57) and 11% (8/74), diffuse panbrochiolitis of 4% (2/57) and 5% (4/74), bronchial asthma of 25% (14/57) and 16% (12/74). 3) In final global improvement rating, Moderately Improved or better was 65% (37/57) in the open study, and 82% (12/74) in the long-term study. 4) In final safety evaluation, Safe was 79% (58/73) in the open study and 85% (70/82) in the long-term study. 5) In final usefulness evaluation, Useful or better was 53% (31/59) in the open study and 78% (58/74) in the long-term study.... (author abst.) |
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