Phase III Open Clinical Study of SS320A in Patients with Chronic Respiratory Diseases.
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Accession number;02A0208997
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| Title;Phase III Open Clinical Study of SS320A in Patients with Chronic Respiratory Diseases. |
| Author;
NAGAOKA SHIGERU
(Japan Res. Inst. Sputum)
TAKISHIMA TAMOTSU
(Tohoku Univ.)
NAGANO HITOSHI
(National Sanatorium Minami Fukuoka Hospital)
KAWAKAMI YOSHIKAZU
(Hokkaido Univ., Sch. of Med.)
KITAMURA SATOSHI
(Jichi Med. Sch.)
KAWAKAMI MASAHIKO
(Tokyotohiroobyoin Kokyukika)
NOGUCHI EISEI
(Showadai Fujigaokabyoin Kokyukinaika)
OGURA TAKESHI
(National Sanatorium Toneyama Hospital)
SASAKI TAKAO
(Tottori Univ., Fac. of Med.)
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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.181-208(2002)
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| Figure&Table&Reference;FIG.2, TBL.23, REF.12 |
| 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 a clinical study. 1) Total number of the subjects was 166. Final global improvement was analyzed in 116, the safety was analyzed in 150, and the usefulness was analyzed in 119. 2) Moderately Improved or better in the final global improvement was seen in 75% (87/116), showing high efficacy. Final global improvement rate of the analytical patients classified by disease was 73% (19/26) for chronic bronchitis, 57% (8/14) for bronchiectasis, 80% (12/15) for pulmonary emphysema, 100% (6/6) for atypical mycobacterial disease, 93% (14/15) for pulmonary tuberculosis, 61% (11/18) for coniosis, 50% (2/4) for lung cancer, 100% (1/1) for diffuse panbrochiolitis, 82% (14/17) for bronchial asthma, showing excellent efficacy for the treatment of chronic respiratory diseases. There were only small differences in improvement rates between the diseases. 3) In final safety evaluation, Safe was 85% (128/150), a high value. 4) In final usefulness evaluation, Useful or better was 66% (78/119), showing a highly useful profile. 5) For final global improvement classified by week, Moderately Improved or better was 63% (73/115) after 1 week, and 78% (86/110) after 2 weeks, confirming higher rate with the passage of time. 6) As for improvement rate classified by symptom, 1 step improvement or better in "sensation of chest obstruction with sputum" was 48% (55/115) after 1 week and 78% (86/110) after 2 weeks. One step improvement or better in "sputum sticking sensation" was 57% (66/115) after 1 week and 72% (79/110) after 2 weeks. 7) Side effects were seen in 8.0% (12/150). The most common symptoms were digestive systems such as nausea, anorexia, constipation, and diarrhea. They were not serious, and considered not clinically significant problems.... (author abst.) |
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