Orchard grass pollinosis
Conditions
Interventions
Epinastine hydrochloride tablet 20 mg is orally administered to subjects as single dose 60 minutes after the first nasal provocation with orchard grass pollen antigen disc.
Matched placebo of epinast
Sponsors
Nippon Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: CAP-RAST score against orchard grass pollen over class 3 or greater within the last 3 years, and positive nasal provocation reaction to the orchard grass antigen disc on screening.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effects of epinastine hydrochloride on nasal symptoms for nasal provocation test by orchard grass pollen antigen disc | — |
Secondary
| Measure | Time frame |
|---|---|
| Nasal finding score by rhinoscopy | — |
Countries
Japan
Contacts
Public ContactYasushi Saito
Tokyo Clinical CRO Co, Ltd Clinical Development II
Outcome results
None listed