A Dose-response Study of Salmeterol Xinafoate Dry Powder by Single Administration for Adult with Bronchial Asthma-Randomized Double-blind, Cross Over Study-
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Accession number;03A0402380
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| Title;A Dose-response Study of Salmeterol Xinafoate Dry Powder by Single Administration for Adult with Bronchial Asthma-Randomized Double-blind, Cross Over Study- |
| Author;
KAWAI MITSURU
(Kokyukakawaiiin)
TAKAORI SHUJI
(Koseikai Takaori Hospital, JPN)
NAKAJIMA MICHIRO
(Koseikai Takaori Hospital, JPN)
NAKAMURA YOSHINORI
(Koseikai Takaori Hospital, JPN)
AKAMATSU KATSUHIRO
(Koseikai Takaori Hospital, JPN)
NAKASHIMA MITSUYOSHI
(Hamamatsucptken)
MIYAMOTO TERUMASA
(Nihon Rinsho Arerugi Kenkyusho)
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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.19;NO.5;PAGE.497-506(2003)
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| Figure&Table&Reference;FIG.3, TBL.4, REF.14 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;A double-blind, cross over study was conducted to evaluate the dose-response of salmeterol xinafoate dry powder for treatment of bronchial asthma. Adult patients received salmeterol xinafoate dry powder at single doses of 12.5, 50 or 100 .MU.g or placebo via Diskhaler. Primary endpoint was evaluated by AUC0-12 (area under the FEV1.0 rate of change curve from administration 0 to 12 hours). All doses of salmeterol xinafoate dry powder were significantly better than placebo in improvement of AUG0-12, and then dose-response relationship of salmeterol xinafoate was confirmed. Adverse events during test drugs administration were emerged 11 cases in 7 patients including abnormal changes of clinical laboratory test in 25 safety population. But, adverse events that were undeniable to relate to test drugs were not admitted during salmeterol xinafoate administration while a patient show exacerbation of asthma when placebo was administered. (author abst.) |
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