Placebo-controlled trial to compare the inhibitory and protective efficacy of epinastine hydrochloride on nasal symptoms, using a nasal provocation test with orchard grass pollen antigen disc in orchard grass pollinosis.
- Conditions
- Orchard grass pollinosis
- Registration Number
- JPRN-UMIN000002721
- Lead Sponsor
- ippon Medical School
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 16
Not provided
Subjects; 1) with a history of hypersensitivity to the components of epinastine hydrochloride tablet, 2) used steroids within one month of the start day of the clinical study, 3) within one week of the start day of the clinical study, used drugs that may affect the results of the clinical study (antihistamines, antiallergic drugs, vasoconstrictors), 4) without nasal response to the provocation by a history of laser therapy and/or nasal procedure for undergoing desensitization to orchard grass pollinosis, 5) with nasal diseases that affect the assessment of the nasal provocation reaction, such as acute chronic rhinitis, nasal polyps, hypertrophic rhinitis, deviated septum or sinusitis, 6) reactive to multiple antigens including pollens (cedar, mugwort) other than orchard grass, and had worsening of nasal symptoms when the nasal provocation test was conducted during the pollen dispersal season, 7) pregnancy, potential pregnancy, and breast-feeding mothers.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effects of epinastine hydrochloride on nasal symptoms for nasal provocation test by orchard grass pollen antigen disc
- Secondary Outcome Measures
Name Time Method asal finding score by rhinoscopy