NCT01777464终止不适用
Role of the Central Nervous System in Allergic Rhinitis: Activation of Different Brain Regions After a Nasal Histamine Provocation in Healthy and Allergic Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 2
- 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
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)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Evaluation of the Nasal and Conjunctival Response in Subjects Allergic to Birch Pollen in the ALYATEC Environmental Exposure ChamberAllergy to PollenRhinoconjunctivitisAllergic RhinitisNCT04583202Alyatec30
已完成
不适用
Study Evaluating Nasal Symptoms Induced by a Nasal Allergen Challenge (NAC) To House Dust Mite AllergenAllergic RhinitisNCT01936818ORA, Inc.21
已完成
不适用
AsthMatic Inflammation and Neurocircuitry Activation (MINA)Allergic AsthmaNCT02764437University of Wisconsin, Madison43
暂停
不适用
Pathophysiological analysis of allergic rhinitis using a pollen challenge chamberAllergic rhinitisJPRN-UMIN000015036Dept. of Otolaryngology Head and Neck Surgery, Graduate School of Medicine, Chiba University20
终止
1 期
Evaluation of the Effect of a Nasal Allergen Challenge With Dermatophagoides Farinae Extract on Nasal Airway Inflammation in Allergic Individuals, Comparing E-cigarette Users to Cigarette Smokers and Non-smokers.Healthy ParticipantsTobacco SmokersNCT03023397University of North Carolina, Chapel Hill12