Role of the Central Nervous System in Allergic Rhinitis
- Conditions
- House Dust Mite Allergy
- Interventions
- Biological: histamineBiological: sham
- Registration Number
- NCT01777464
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
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.
- Detailed Description
Evaluate the effects a nasal provocation on the activation of different brain regions
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 14
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description healthy controls histamine healthy controls receive sham solution for 5 minutes on first visit and histamine (16mg/ml) for 5 minutes on second visit healthy controls sham healthy controls receive sham solution for 5 minutes on first visit and histamine (16mg/ml) for 5 minutes on second visit patients histamine 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 patients sham 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
- Primary Outcome Measures
Name Time Method brain activation 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.
- Secondary Outcome Measures
Name Time Method nasal symptoms and Peak Nasal Inspiratory Flow before and after scans Evaluation of nasal symptoms (runny nose, blocked nose, itchy nose and post-nasal drip) and conjunctival symptoms (lacrimation and itchy eyes) will be done with VAS scores and the Peak Nasal Inspiratory Flow (PNIF) will be measured before and after both functional MRI (fMRI) scans
Trial Locations
- Locations (1)
uz leuven ORL
🇧🇪Leuven, Vlaams Brabant, Belgium