Clinical Study of Salmeterol Xinafoate (SN408) Dry Powder. Examination in Children with Bronchial Asthma.
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Accession number;02A0595854
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| Title;Clinical Study of Salmeterol Xinafoate (SN408) Dry Powder. Examination in Children with Bronchial Asthma. |
| Author;
MIKAWA HARUKI
(Kyoto Univ., Fac. of Med.)
BABA MINORU
(Fratern. Memol. Hosp.)
WAGATSUMA YOSHINORI
(Sapporo City Hosp.)
MORIKAWA AKIHIRO
(Gunma Univ.)
ICHIMURA TOJU
(Dokkyo Univ. Sch. of Med.)
ARITA MASAHIKO
(Showa Univ.)
MASAKI TAKURO
(Jikei Univ. School of Medicine)
IIKURA YOJI
(National Children's Hospital)
SHIKE SHOICHIRO
(Kanazawa Med. 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.6;PAGE.821-835(2002)
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| Figure&Table&Reference;FIG.4, TBL.17, REF.7 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;Efficacy, safety and clinical usefulness of salmeterol xinafoate dry powder were examined in a open study following its 50.MU.g/day (25.MU.g b.i.d.) repeated administration to children with bronchial asthma. 1) Out of 45 patients in total, final overall improvement, overall safety and clinical usefulness were assessed in 39, 45 and 39 patients, respectively. 2) In the final overall improvement, 38.5 % was evaluated as "Markedly improved" 74.4 %, and as "Moderately improved" or better. 3) "Useful" or better results was achieved by 69.2 % of patients in the clinical usefulness. 4) In the overall safety, 95.6 % was assessed as "Safe". 5) Tremor and palpitation appeared as adverse events in 1 patient, but neither of the events was severe. They disappeared without treatment. Increase was also observed in WBC and neutrophil as abnormal clinical laboratory findings, but none of them was severe. From the above data, salmeterol xinafoate dry powder was established to be effective and highly safe drug, which was useful when 50.MU.g/day dose was administered to children with bronchial asthma, similarly to salmeterol xinafoate aerosol. (author abst.) |
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