House Dust Mite Allergy
Conditions
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
Interventions
BIOLOGICALhistamine
administration of histamine solution (16 mg/ml) via aerosol for 5 minutes while lying under a fMRI scan
BIOLOGICALsham
sham solution
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Belgium
Outcome results
None listed