Clinical Study of Salmeterol Xinafoate (SN408) Aerosol. Comparative Study by Multiple Administration in Patients with Chronic Obstructive Pulmonary Diseases.
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Accession number;02A0580204
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| Title;Clinical Study of Salmeterol Xinafoate (SN408) Aerosol. Comparative Study by Multiple Administration in Patients with Chronic Obstructive Pulmonary Diseases. |
| Author;
MIYAMOTO TERUMASA
(Sagamihara National Hospital)
TAKISHIMA TAMOTSU
(Tohoku Univ., Sch. of Med.)
TAKIZAWA TAKAO
(Tokyo Women's Med. Coll.)
NAKASHIMA MITSUYOSHI
(Hamamatsu Univ. Sch. 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.3;PAGE.437-459(2002)
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| Figure&Table&Reference;FIG.6, TBL.15, REF.7 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;The 3 dose levels (25.MU.g b.i.d. 5.MU.g/day dose group, 5.MU.g b.i.d. : 100.MU.g/day dose group and 100.MU.g b.i.d. : 200.MU.g/day dose group) of salmeterol xinafoate metered-dose aerosol were administered for 4 consecutive weeks to patients with chronic obstructive pulmonary diseases (COPD), mainly chronic bronchitis and pulmonary emphysema, in order to comparatively investigate the clinical efficacy and safety of the different dose levels. 1) Total of 148 patients participated in this study. Of these patients, 117, 138 and 118 were subjects to analyses on final overall improvement, overall safety and clinical usefulness, respectively. 2) "Moderate improvement" or better in assessment of the final overall improvement was achieved by 17.5% in 50.MU.a g/day dose group, 39.5% in 100.MU.g/day dose group and 32.4% in 200.MU.g/day dose group. Compared with 50.MU.g/day dose group, 100.MU.g/day and 200.MU.g/day dose groups showed better improvement. 3) No significant difference among the 3 dose groups was seen in the overall safety. Incidence rates of adverse events were 2.2%, 0% and 12.2% in 50.MU.g/day, 100.MU.g/day and 200.MU.g/day dose groups, respectively. Also, no serious abnormal change associated with the test drug in clinical laboratory examination values nor severe adverse event was observed. 4) In the clinical usefulness, 20.0%, 44.2% and 37.1% in 50.MU.g/day, 100.MU.g/day and 200.MU.g/day dose groups were assessed as "Very useful" or "Useful". Similarly to the final overall improvement, better usefulness was attained in 100.MU.g/day and 200.MU.g/day dose groups than in 50.MU.g/day dose group. The above data show that the 3 dose levels of salmeterol aerosol, when repeatedly administered to patients with COPD, achieved good results. However, 50.MU.g b.i.d. (100.MU.g/day dose) was confirmed to be suitable dosage for maintenance therapy of these diseases considering its efficacy, safety and clinical usefulness.(author abst.) |
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