Japanese cedar pollinosis
Conditions
Interventions
None listed
Sponsors
Ohashi-Doi Katsuyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Age: over 20 years of age and under 65 years of age (2) Sex: Any (3) Participants with Japanese cedar specific IgE levels of Class 2 (0.7 kUa/L) or higher and Japanese cypress specific IgE levels of Class 2 (0.7 kUa/L) or higher on tests conducted at screening visit (Visit 1) or within 90 days before the screening test date (Visit 1) (4) Participants who have one or more allergic rhinitis symptoms (sneezing, nasal discharge, nasal obstruction, or itchy nose) during Japanese cedar and japanese cypress season in the two years preceding the screening visit (Visit 1). (Japanese cedar season; February to April, Japanese cypress season: March to May)
Exclusion criteria
Exclusion criteria: (1) Participants who have a treatment history as following: 1) Within 24 weeks prior to the screening visit (Visit 1) -Antihistamines (injection) -Biologics (e.g., omalizumab, dupilumab) -Steroid hormones (oral, patch, injection, suppository, inhaled) -Immunosuppressive drugs (oral, injection) -Live vaccines 2) Within 3 years prior to the screening visit (Visit 1) -Laser treatment or surgery to treat nasal symptoms 3) Entire period in the past -Allergy immunotherapy (Japanese cedar pollen)" (2) Participants with specific IgE levels of Class 5 (50 kUa/L) or higher against to either of following allergens on tests conducted at screening visit (Visit 1) or within 90 days before the screening test date (Visit 1). (Dermatophagoides pteronyssinus, Dermatophagoides farinae, cat dander, dog dander, Orchardgrass or ragweed) (3) Participants who have allergic rhinitis symptoms requiring any treatment from September to December in the two years preceding the screening visit (Visit 1). (4) Participants who have rhinitis symptoms due to adenoids, chronic sinusitis, nasal polyps, nasal septal curvature, vasomotor rhinitis, etc. at the screening visit (Visit 1). (5) Participants with bronchial asthma or respiratory disease. (6) Participants with serious comorbidity in the brain, liver, kidney, heart, lungs, digestive organs, blood, endocrine system, metabolic system, and mental system. (7) Participants who have a comorbid malignancy or a history of malignancy within 5 years prior to the screening visit (Visit 1) (8) Participants who participated in another clinical study with intervention within 12 weeks prior to enrollment of this study (9) Pregnant women, lactating women, women who may be pregnant, or who wish to become pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total nasal symptom score(TNSS; sum of 4 nasal symptom scores:sneezing, nasal discharge, nasal obstraction and itchy nose ) | — |
Secondary
| Measure | Time frame |
|---|---|
| Total ocular symptom score(TOSS) Total nasal and ocular symptom score(TNOSS) Individual symptom score Number of sneezing The weight of nasal mucosa | — |
Contacts
Public ContactSatoko Kobayashi
Torii Pharmaceutical Co., Ltd.
Outcome results
None listed