Japanese cedar pollinosis
Conditions
Interventions
Investigational drug: CEDARCURE Japanese cedar pollen sublingual tablets
Dosage and administration: same as instructions in the package insert
Administration period: around 12 months
Sponsors
Ozaki Hideki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female aged between 18 and 64 years on the date informed consent is obtained. - Patients with Japanese cedar-specific IgE levels and Japanese cypress-specific IgE levels of class 2 or higher (>=0.7 UA/mL) in blood tests conducted on the screening visit or within 90 days before the screening visit. - Patients with allergic rhinitis of mild severity or greater during the Japanese cedar pollen season (February to April) and Japanese cypress pollen season (March to May) in 2024 and 2025. etc.
Exclusion criteria
Exclusion criteria: - Patients with Dermatophagoides pteronyssinus-specific IgE levels of class 5 or higher in blood tests conducted on the screening visit or within 90 days before the screening visit. - Patients with nasal symptoms (excluding symptoms induced by pollen exposure in the EEC) affecting assessment on nasal symptoms in the EEC on visits in the screening period (Visit 2 to Visit 6) - Patients with bronchial asthma or respiratory complications - Patients with complications of serious diseases of the brain, liver, kidney, heart, lung, gastrointestinal, hematological, endocrine, metabolic and psychiatric systems etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in TNSS120-180 assessed on day 2 of Japanese cedar pollen exposure [Time frame: Baseline to 1-year Japanese cedar pollen sublingual tablets administration] Note: TNSS (total nasal symptom score); sum of scores for sneezing, rhinorrhea, nasal obstruction and nasal itching., TNSS120-180; mean TNSS assessed at 120, 150 and 180 minutes of pollen exposure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary endpoint: Change from baseline in TNSS120-180 assessed on day 3 of Japanese cypress pollen exposure [Time frame: Baseline to 1-year Japanese cedar pollen sublingual tablets administration]. Secondary endpoints: - Change from baseline in the following items assessed on day 2 of Japanese cedar pollen exposure or day 3 of Japanese cypress pollen exposure [Time frame: Baseline to 1-year Japanese cedar pollen sublingual tablets administration]. - TOSS120-180 - TNOSS120-180 - Mean of individual symptom score (sneezing, rhinorrhea, nasal obstruction, nasal itching, ocular itching/grittiness/redness and ocular tearing.) assessed at 120, 150 and 180 minutes of pollen exposure - Total number of sneezing during 3 hours of pollen exposure - Weight of nasal discharge during 3 hours of pollen exposure - Japanese Allergic rhinitis Standard Quality of Life Questionnaire (JRQLQ No. 1). [Time point: Japanese cedar pollen season, Japanese cypress pollen season] Note: TOSS (total ocular symptom score); sum of scores for ocular itching/grittiness/redness and ocular tearing., TNOSS (total nasal and ocular symptom score); sum of TNSS and TOSS., TOSS120-180/TNOSS120-180; mean TOSS/TNOSS assessed at 120, 150 and 180 minutes of pollen exposure. | — |
Contacts
Public ContactHideki Ozaki
Torii Pharmaceutical Co., Ltd.
Outcome results
None listed