jRCT1030230500已完成不适用
The establishment of protocols in Japanese cypress pollen exposure chamber
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Total nasal symptom score
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 over 至 65age old not（—）
- 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:
- •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
- •Within 3 years prior to the screening visit (Visit 1)
- •Laser treatment or surgery to treat nasal symptoms
- •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.
结局指标
主要结局
Total nasal symptom score
sum of 4 nasal symptom scores: sneezing, nasal discharge, nasal obstraction and itchy nose
次要结局
未报告次要终点
研究者
相似试验
进行中（未招募）
Unknown
The establishment of protocols in Japanese cypress pollen exposure chamberJapanese cedar pollinosisJPRN-jRCT1030230500Ohashi-Doi Katsuyo100
招募中
不适用
Establishment of Japanese-originated comprehensive biomarker system for diagnosis and stratification of patients with various types of dementias based on multicenter alliance for brain biomarkers (MABB)Mild cognitive impairmentJPRN-UMIN000047214Japan Agency for Medical Research and Development240
招募中
不适用
Pilot study of cognitive-behavioral therapy for Japanese adolescents with depression and/or anxietyJPRN-jRCT1030210215Ito Masaya12
尚未招募
Unknown
Development and Validation of the Japanese Version of J-WEQOepiphoraJPRN-jRCT1030230172Hoshi Sujin130
招募中
不适用
Development and validation of the Japanese version of EPDS-P for indirect screening of paternal perinatal depression based on maternal reporting: protocol for a prospective longitudinal observational studyJPRN-UMIN000045584Dokkyo Medical University, School of Medicine600