Role of the Central Nervous System in Allergic Rhinitis

Universitaire Ziekenhuizen KU Leuven

Status: Terminated

Conditions: House Dust Mite Allergy

Treatments: Biological: histamine; Biological: sham

Study type: Interventional

Funder types: Other

Identifiers

NCT01777464

september2012

Details and patient eligibility

About

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.

Full description

Evaluate the effects a nasal provocation on the activation of different brain regions

Enrollment: 14 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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14 participants in 2 patient groups

patients

Experimental group

Description:

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

Treatment:

Biological: sham

Biological: histamine

healthy controls

Sham Comparator group

Description:

healthy controls receive sham solution for 5 minutes on first visit and histamine (16mg/ml) for 5 minutes on second visit

Treatment:

Biological: sham

Biological: histamine