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Accession number;02A0580205
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| Title;Clinical Study of Salmeterol Xinafoate (SN408) Aerosol in Patients with Bronchial Asthma. Comparison with Concurrent Use of Azelastine Hydrochloride Tablet + Salbutamol Sulfate Tablet. |
| Author;
MIYAMOTO TERUMASA
(Sagamihara National Hospital)
TAKISHIMA TAMOTSU
(Tohoku Univ., Sch. of Med.)
MAKINO SOHEI
(Dokkyo Univ. Sch. of Med.)
KABE JUNZABUROIU
(National Medical Center Hospital)
TAKAHASHI TERUMI
(Showa Univ., Sch. of Med.)
YAMAKIDO MICHIRO
(Hiroshima Univ., Sch. of Med.)
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.461-483(2002)
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| Figure&Table&Reference;FIG.11, TBL.17, REF.11 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;Clinical usefulness of salmeterol xinafoate metered-dose aerosol in patients with bronchial asthma was examined by envelope method in multi-centre trial. In this investigation, concurrent use of azelastine hydrochloride tablet and salbutamol sulfate tablet was adopted as control. Fifty .MU.g b.i.d. of salmeterol aerosol and 2mg b.i.d. of azelastine + 4mg t.i.d. of salbutamol tablets were administered for 6 consecutive weeks. 1) One hundred and twenty-nine patients were recruited for this study, and 120 cases out of those were subject to analysis [salmeterol group (SM group): 67 patients, azelastine + salbutamol group (A SB group): 53 patientsj, 9 patients were excluded. There was no deviation noted in the patient demographic that could affect the efficacy assessment. 2) SM group achieved significantly better result than A SB group in overall improvement."Moderately improved" or better was 65.3% in SM group and 36.8% in A SB group. 3) No significant difference was seen in overall safety of the 2 groups where 85.1% in SM group and 79.2% in A SB group were assessed to be "Safe". 4) SM group was significantly superior to A SB group in clinical usefulness. "Useful" or better was achieved by 62.3% in SM group and 31.8% in A SB group. 5) Nine patients (13.4%) in SM group and 9 patients (17.0%) in A SB group were reported to experience of adverse events, but no event was considered to be a clinical problem. Although abnormal changes in clinical laboratory examinations appeared in 2 cases in A SB group, no change was serious. Concluding from these results, salmeterol aerosol is superior to the concurrent therapy of azelastine hydrochloride + salbutamol sulfate tablets in final overall improvement, overall safety and clinical usefulness against bronchial asthma in adults. Thus it is established as a promising drug with high efficacy in treatment and management of such disease. (author abst.) |
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