The establishment of protocols in Japanese cypress pollen exposure chamber

JRCT ID: jRCT1030230500

Registered date:09/12/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Japanese cedar pollinosis
• Date of first enrollment: 15/09/2023
• Target sample size: 100
• Study type: Observational

Outcome(s)

• Primary Outcome: Total nasal symptom score(TNSS; sum of 4 nasal symptom scores:sneezing, nasal discharge, nasal obstraction and itchy nose )

Secondary Outcome

Total ocular symptom score(TOSS)
Total nasal and ocular symptom score(TNOSS)
Individual symptom score
Number of sneezing
The weight of nasal mucosa

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 65age old
• Gender: Both

Include 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)

Exclude 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.

Related Information

• Primary Sponsor: Ohashi-Doi Katsuyo
• Source(s) of Monetary Support: Torii Pharmaceutical Co., Ltd.