Early phase II study of TAC-202 in Japanese cedar pollinosis exposure to antigen in an environmental exposure chamber.
- Conditions
- Japanese cedar pollinosis
- Registration Number
- JPRN-jRCT2080222167
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 130
Subjects have a history of seasonal allergic rhinitis at the past 2 pollen seasons and had received medication (including oral anti-histaminic drug).
Subjects between 20 and 60 years of age at the time of signing the informed consent.
Subjects are available to complete all study measurements.
Subjects with nose, ocular or ear complications which are disturbed the assessment of efficacy for the study drug.
Subjects with a history of intranasal operative treatment (coagulation necrosis or excision).
Subjects with a history of specific immunotherapy (including sublingual) or nonspecific immunotherapy within 5 years prior to consent acquisition.
Subjects who had treatment with steroid within 30 days prior to consent acquisition.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy (Fast action)<br>Sum of TNSS from 0 to 3h after the first drug administration.
- Secondary Outcome Measures
Name Time Method Efficacy (Duration of efficacy)<br>Sum of TNSS from 22 to 26h after first drug administration.