Comparison of nasal steroid with anti-histamine in prophylactic treatment against pollinosis using an environmental challenge chamber.
Phase 4
- Conditions
- cedar pollinosis
- Registration Number
- JPRN-jRCT1080221147
- Lead Sponsor
- Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
The age ranged from 18 to 64 years and subjects met the following inclusion criteria: a positive allergen-specific skin test (wheal diameter: 10mm or >10mm) to a standardized cedar pollen extract (Torii Pharmaceutical Co. Ltd., Tokyo, Japan) and serum cedar pollen-specific immunoglobulin (Ig) E level score of 2 or >2 by the CAP radioallergosorbent test (CAP-RAST; SRL, Tokyo, Japan).
Exclusion Criteria
The exclusion criteria included complication of moderate/severe perennial allergic rhinitis which required treated, a history of severe asthma, use of anti-allergic drugs within 4 weeks, and a prior history of any allergen-specific immunotherapy, pregnant women, or women of childbearing potential.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patients received nasal steroid or anti-histamine for 7 consecutive days (days 1-7).<br>The main criteria for the evaluation of efficacy was the TNSS for 0-3 hours during the chamber exposure and 3-12 hours after the exposure on day 8. The primary efficacy variables were the mean TNSS for 0-12 hours on day 8 and the mean TNSS of 0-3 hours only in the chamber on day 8.
- Secondary Outcome Measures
Name Time Method Secondary efficacy variable included: the number of sneezing and rhinorrhea in the chamber (0-3 hours) and after leaving the chamber (3-12 hours) on day 8 and the mean TNSS on days 9-12.