JPRN-jRCT1030230500进行中（未招募）Unknown
The establishment of protocols in Japanese cypress pollen exposure chamber
Ohashi-Doi Katsuyo0 个研究点目标入组 100 人开始时间: 2023年12月9日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- >= 20age old 至 < 65age old（—）
- 性别
- All
入选标准
- •(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)
排除标准
- •(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.
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