Clinical Study of Salmeterol Xinafoate (SN408) Aerosol. Double-blind Parallel Study between Procaterol Tablet in Patients with Bronchial Asthma.
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Accession number;02A0580203
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| Title;Clinical Study of Salmeterol Xinafoate (SN408) Aerosol. Double-blind Parallel Study between Procaterol Tablet in Patients with Bronchial Asthma. |
| Author;
MIYAMOTO TERUMASA
(Sagamihara National Hospital)
TAKISHIMA TAMOTSU
(Tohoku Univ., Sch. of Med.)
MAKINO SOHEI
(Dokkyo Univ. Sch. of Med.)
KABE JUNZABURO
(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.411-436(2002)
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| Figure&Table&Reference;FIG.7, TBL.13, REF.9 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;Efficacy, safety and clinical usefulness of salmeterol xinafoate metered-dose aerosol in 50.MU.g twice daily dosage were comparatively examined with those of procaterol hydrochloride tablet in 50.MU.g twice daily dosage, in 4 week consecutive administration to patients with bronchial asthma. 1) Total of 215 patients participated in this study. Out of these patients 153, 164 and 208 were evaluated for final overall improvement, clinical usefulness and overall safety, respectively. 2) In the assessment of final overall improvement, there was significant difference observed, between salmeterol group (hereafter reffered as SN group) and procaterol group (hereafter reffered as PC group). The rate of moderate or better improvement was 53.7% in SN group and 35.2% in PC group. 3) In the assessment of clinical usefulness, similar results as those in the overall improvement was achieved and significant difference between the two groups was seen. The rate of useful or very useful were 52.4% in SN group and 28.8% in PC group. 4) The rate of patients evaluated as "Safe" in the assessment of overall safety were 89.5% in SN group and 81.6% in PC group. No significant difference between the two groups was observed in safety. But, as the incidence of adverse events for SN group was 7.6% and for PC group it was 16.5%, SN group showed significantly lower incidence than PC group. Though major symptoms were tremor and palpitation in both groups, SN group had fewer cases with such symptoms than PC group, suggesting that salmeterol aerosol had less systemic adverse events than procaterol tablet. Furthermore no abnormal laboratory change regarded to be clinically significant was observed in both groups. Based on the above, salmeterol aerosol is considered to be superior to procaterol tablet in terms of efficacy, safety and clinical usefulness when given to patients with bronchial asthma in its multiple dose, and therefore is an useful inhalant for management of bronchial asthma. (author abst.) |
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