Role of the Central Nervous System in Allergic Rhinitis: Activation of Different Brain Regions After a Nasal Histamine Provocation in Healthy and Allergic Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- brain activation
研究概览
简要总结
In order to evaluate the effects a nasal provocation on the activation of different brain regions, the investigators want to set up a clinical trial investigating the short-term effects of a nasal histamine provocation in healthy volunteers and allergic patients while in supine position under the functional MRI device in order to visualize different brain regions.
详细描述
Evaluate the effects a nasal provocation on the activation of different brain regions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with a positive skin prick test to grass pollen and with pollen allergic symptoms during the pollen season OR patients with a negative skin prick test and with no allergic symptoms during the pollen season.
- •Age > 18 and < 50 years
- •Written informed consent
- •Willingness to adhere to visit schedules
- •Adequate contraceptive precautions in female patients with childbearing potential
排除标准
- •Current or recent (finished less than 2 years) immunotherapy against grass pollen.
- •Systemic steroid treatment less than 6 weeks before the inclusion in the study.
- •Nasal steroid spray, oral leukotriene antagonists or long-acting antihistamines less than 4 weeks before the inclusion.
- •Presence of purulent secretions in nasal cavity.
- •Severe septal deviation (septum reaching concha inferior or lateral nasal wall).
- •Patient is pregnant or breastfeeding.
- •Patient has any disorder of which the investigators feel at the time of evaluation for participation in the study that this may compromise the ability to give truly informed consent for participation in this study.
- •Patient is currently enrolled in other investigational drug trial(s) or is receiving other investigational agent(s) for any other medical condition.
- •No independent medication management in daily life or disability to perform fine motoric handling of medication
- •Patients with asthma will be excluded.
- •Patients suffering from claustrophobia
研究组 & 干预措施
patients
patients allergic to house dust mite receive sham solution for 5 minutes on first visit and histamine (16mg/ml) for 5 minutes on second visit
干预措施: sham (Biological)
healthy controls
healthy controls receive sham solution for 5 minutes on first visit and histamine (16mg/ml) for 5 minutes on second visit
干预措施: sham (Biological)
healthy controls
healthy controls receive sham solution for 5 minutes on first visit and histamine (16mg/ml) for 5 minutes on second visit
干预措施: histamine (Biological)
patients
patients allergic to house dust mite receive sham solution for 5 minutes on first visit and histamine (16mg/ml) for 5 minutes on second visit
干预措施: histamine (Biological)
结局指标
主要结局
brain activation
时间窗: 5 minutes
The specific aim of this study is to visualize the type and location of brain activation in healthy and allergic volunteers by a nasal provocation with histamine, using the functional MRI technology.
次要结局
- nasal symptoms and Peak Nasal Inspiratory Flow(before and after scans)