Clinical Study of Seratrodast, a Thromboxane A2 Antagonist, in Perennial Allergic Rhinitis for 12-week Target Date.

Accession number;99A0315573
Title;Clinical Study of Seratrodast, a Thromboxane A2 Antagonist, in Perennial Allergic Rhinitis for 12-week Target Date.
Author; TAKASAKA TOMONORI (Tohoku Univ., Sch. of Med.) IKEDA KATSUHISA (Tohoku Univ., Sch. of Med.) OSHIMA TAKESHI (Tohoku Univ., Sch. of Med.) MATSUTANI SACHIKO (Japan Red Cross Sendai Hosp.) SUGAWARA MITSURU (Japan Red Cross Sendai Hosp.) SAKURADA TAKASHI (Sendai Posts and Telecommun. Hosp.) AWATAGUCHI TOSHIICHI (Tohoku Kosei Nenkin Hosp.) SHIMOMURA AKIRA (Tohoku Kosei Nenkin Hosp.) TANNO NORIKO (Koritsu Soma Sogo Byoin)
Journal Title;Journal of Clinical Therapeutics & Medicines
Journal Code:Y0906A
ISSN:0910-8211
VOL.15;NO.2;PAGE.339-353(1999)
Figure&Table&Reference;FIG.1, TBL.14, REF.13
Pub. Country;Japan
Language;Japanese
Abstract;Seratrodast, a thromboxane A2 antagonist AA-2414, was given to the patients with perennial allergic rhinitis at 80mg/day for 12-weeks (target day) to determine its efficacy and safety in a long-term administration. 1) Eight subjects were given the test drug. Of the eight, seven were handled as "subjects evaluable for main efficacy", and all the eight were handled as "subjects evaluable for safety." 2) Improvement rate in nasal symptoms as primary end point (at the final evaluation): "moderate improvement" or better was 57.1% (4/7). 3) Improvement rates classified by symptoms (at the final evaluation): "moderate improvement" or better were 71.4% (5/7) for nasal obstruction, 0.0% (0/7) for nasal discharge, and 0.0% (0/5) for sneezing. "Slight improvement" or better were 71.4% (5/7) for nasal obstruction, 28.6% (2/7) for nasal discharge, and 20.0% (1/5) for sneezing, demonstrating high improvement specifically to nasal obstruction. 4) Improvement rate in nasal symptoms over the time course: "moderate improvement" or better were 33.3% (2/6), 80.0% (4/5), and 50.0% (1/2) respectively for 4, 8, and 12 weeks after administration of the test drug. No aggravation in symptoms was found during the test period. 5) Improvement rate in nasal obstruction over the time course: "moderate improvement" or better were 50.0% (3/6), 80.0% (4/5), and 50.0% (1/2) respectively for 4, 8, and 12 weeks after administration. 6) Safety: neither accompanying symptoms nor abnormal changes in laboratory test values where causality with the test drug could not be denied were found. These results show that AA-2414 is highly effective in treating perennial allergic rhinitis, and has no safety problems in a long-term use. (author abst.)