Role of the Central Nervous System in Allergic Rhinitis

Role of the Central Nervous System in Allergic Rhinitis: Activation of Different Brain Regions After a Nasal Histamine Provocation in Healthy and Allergic Patients

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.

Study Overview

• Status: Terminated
• Conditions: House Dust Mite Allergy
• Intervention / Treatment: Biological: histamine; Biological: sham

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • UZ Leuven ORL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Biological: histamine; administration of histamine solution (16 mg/ml) via aerosol for 5 minutes while lying under a fMRI scan; Biological: sham; sham solution
Sham Comparator: healthy controls; healthy controls receive sham solution for 5 minutes on first visit and histamine (16mg/ml) for 5 minutes on second visit	Biological: histamine; administration of histamine solution (16 mg/ml) via aerosol for 5 minutes while lying under a fMRI scan; Biological: sham; sham solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
brain activation	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.	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nasal symptoms and Peak Nasal Inspiratory Flow	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	before and after scans

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Peter Hellings, Dr, KU Leuven

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Anticipated): February 1, 2016
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: January 23, 2013
• First Submitted That Met QC Criteria: January 25, 2013
• First Posted (Estimate): January 28, 2013

Study Record Updates

• Last Update Posted (Estimate): December 3, 2015
• Last Update Submitted That Met QC Criteria: December 2, 2015
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Histamine Agents; Histamine Agonists; Histamine
• Other Study ID Numbers: september2012