Local IgE in Subjects With Allergic or Non-allergic Rhinitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Comparison of IgE between 24 subjects with non-allergic rhinitis, 24 subjects with allergic rhinitis and 20 healthy subjects.
研究概览
简要总结
The purpose of the study is to investigate the incidence of non-allergic rhinitis on a not selected group of young students (n=100-300). Students will be selected by public posting. In all students an allergy skin test will be performed. Then the local IgE of 24 subjects with non-allergic rhinitis will be compared to the local IgE of 24 subjects with allergic rhinitis and positive prick test to house dust mite. In addition 20 controlls will be investigated. Based on these investigations, the importance of local IgE and the IgE spectrum in conjunction with rhinitis should be further clarified.
详细描述
20% of Germans suffer from seasonal or all-season rhinitis. Despite typical allergic symptoms, in a part of the affected patients (about 10-20%) an allergy cannot be found on skin prick test or blood. Therefore, the planned trial will investigate the incidence of allergic and non-allergic rhinitis in a non selected group of young students (n=100-300). The hypothesis postulates that in test subjects with non-allergic rhinitis the allergy can only be proven locally in nasal secretion.
From the initial large cohort of patients, 24 subjects with house dust mite allergy and allergic rhinitis and 24 patients with non-allergic rhinitis will be selected and investigated in more detail at a second visit. At the second visit, blood and nasal secretion (measurement of local IgE) will be taken from all pre-selected 48 patients. At visit 2 a nasal provocation test with house dust mite allergen will be performed in all patients to compare nasal symptoms with the results of local IgE between patient groups. In addition the same investigations will be performed in a group of 20 healthy non-allergic subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent
- •Seasonal or all-season symptoms of an allergic or non-allergic rhinitis
- •Healthy non-allergic subjects
排除标准
- •Patients: Age <18 and > 45
- •Other severe diseases (e.g. Cystic fibrosis, diseases with immunosuppression, malignant diseases)
- •Previously occurred allergic shock
- •Pregnancy and lactation
- •Participation in another clinical trial within the last 30 days
- •Inability to measure the length and the consequences of the study
- •Frequent use of medication which could not be discontinued in the defined time before enrollment: nasal vasoconstrictors 1 day; antihistamines 3 days; nasal steroids 7 days; oral cortison 4 weeks; leukotriene antagonists and cromolyn 2 days before NPT
研究组 & 干预措施
Non-allergic rhinitis
Clinical observation of 24 subjects with nasal symptoms and negative prick test for house dust mite
干预措施: Observation (Other)
Allergic rhinitis
Clinical observation of 24 subjects with nasal symptoms and positive prick test for house dust mite
干预措施: Observation (Other)
Healthy Control
Clinical observation of 20 subjects without nasal symptoms and with negative prick test
干预措施: Observation (Other)
结局指标
主要结局
Comparison of IgE between 24 subjects with non-allergic rhinitis, 24 subjects with allergic rhinitis and 20 healthy subjects.
时间窗: one year
次要结局
- Correlation between Peak Nasal Inspiratory Flow as well as the nasal symptoms in nasal provocation test and local specific IgE.(one year)
- Explorative Measures: Comparison of the nasal and serum epitope spectrum with the new mite specific IgE component-chip in subjects with allergic rhinitis.(one year)
- Comparison of specific IgE between 24 subjects with non-allergic rhinitis, 24 subjects with allergic rhinitis and 20 healthy subjects.(one year)
研究者
Stefan Zielen
Professor of pediatrics, allergy, pneumology, cystic fibrosis
Johann Wolfgang Goethe University Hospital