Study on Administration of 80mg/day and 120mg/day of Seratrodast in Perennial Allergic Rhinitis Patients.
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Accession number;99A0315570
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| Title;Study on Administration of 80mg/day and 120mg/day of Seratrodast in Perennial Allergic Rhinitis Patients. |
| Author;
UNNO TOKUJI
(Asahikawa Med. Coll.)
KAWABORI SHIN'ICHI
(Asahikawa Med. Coll.)
KAGA KIMITAKA
(Univ. of Tokyo, Fac. of Med.)
ICHIMURA KEIICHI
(Univ. of Tokyo, Fac. 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.15;NO.2;PAGE.247-266(1999)
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| Figure&Table&Reference;FIG.3, TBL.20, REF.12 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;AA-2414 at 80mg and 120mg daily doses was examined for efficacy and safety in treating perennial allergic rhinitis. The number of subjects totaled 53, comprising 26 in the 80mg/day group and 27 in the 120mg/day group. The test drug at 80mg or 120mg was given once daily for 4 weeks in an open study. 1) Improvement rate in nasal symptoms: (primary end point): "moderately improved" or better totaled 50.0% (12/24) in both the 80 and 120mg/day groups. 2) Improvement rate classified by symptoms: "markedly improved" or better in nasal obstruction, nasal discharge, and sneezing were respectively 37.5%, 26.1%, and 33.3% in the 80mg/day group, and 36.4%, 25.0%, and 20.8% in the 120mg/day group. 3) Improvement in degree of obstruction in daily life: "markedly improved" or better totaled 45.0% in the 80mg/day group, and 33.3% in the 120mg/day group. Patient's selfvaluation of the drug: 33.3% in the 80mg/day group answered "very good" or "good", and 25.0% in the 120mg/day group answered similarly. 4) Safety rating: treatment-related signs and symptoms where causality with the test drug could not be denied were stomach discomfort, seen in 1 case (3.8%) in the 80mg/day group and eruption and diarrhea accompanied by stomachache in 2 cases each (7.7%) in the 120mg/day group. Abnormal change in laboratory data was only positive urinary blood in 1 case (3.8%) in the 120mg/day group. None of the signs and symptoms or abnormal changes were clinically significant. From the above results, it was concluded that 80mg/day or 120mg/day dosage of AA-2414 are equivalent in efficacy and safety in the treatment of perennial allergic rhinitis. In a dose finding study using 4, 40 and 80mg/day, which was conducted in parallel with this study, 80mg/day was suggested to be optimal for clinical use. Considering the results of the two studies together, it was concluded that 80mg/day is the most appropriate clinical dosage of the agent for the treatment of perennial allergic rhinitis. (author abst.) |
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