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Role of the Central Nervous System in Allergic Rhinitis

This study is currently recruiting participants.
Verified January 2013 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01777464
First received: January 23, 2013
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
House Dust Mite Allergy
 Biological: histamin
Biological: sham

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Role of the Central Nervous System in Allergic Rhinitis: Activation of Different Brain Regions After a Nasal Histamine Provocation in Healthy and Allergic Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • brain activation [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
    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:
  • nasal symptoms and Peak Nasal Inspiratory Flow [ Time Frame: before and after scans ] [ Designated as safety issue: No ]
    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 Inspriatory Flow (PNIF) will be measured before and after both fMRI scans


Estimated Enrollment: 16
Study Start Date: November 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: patients
patients allergic to house dust mite receive sham solution for 5 minutes on first visit and histamin (16mg/ml) for 5 minutes on second visit
 Biological: histamin
administration of histamin 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 histamin (16mg/ml) for 5 minutes on second visit
 Biological: histamin
administration of histamin solution (16 mg/ml) via aerosol for 5 minutes while lying under a fMRI scan
Biological: sham
sham solution

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777464

Contacts
Contact: Ina Callebaut, PhD, fellow ina.callebaut@med.kuleuven.be
Contact: Emily Dekimpe, Msc emily.dekimpe@uzleuven.be

Locations
Belgium
uz leuven ORL Recruiting
Leuven, Vlaams Brabant, Belgium, 3000
Contact: emily dekimpe, msc         emily.dekimpe@uzleuven.be    
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Peter Hellings, Dr KU Leuven
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01777464     History of Changes
Other Study ID Numbers: september2012
Study First Received: January 23, 2013
Last Updated: January 25, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Histamine
 Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013