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Role of the Central Nervous System in Allergic Rhinitis

This study is currently recruiting participants.
Verified May 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: May 21, 2013
Last verified: May 2013
History of Changes

January 23, 2013
May 21, 2013
November 2012
September 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01777464 on ClinicalTrials.gov Archive Site
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 Inspiratory Flow (PNIF) will be measured before and after both fMRI scans
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
Not Provided
Not Provided
 
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.

Evaluate the effects a nasal provocation on the activation of different brain regions
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
House Dust Mite Allergy
  • Biological: histamine
    administration of histamine solution (16 mg/ml) via aerosol for 5 minutes while lying under a fMRI scan
  • Biological: sham
    sham solution
  • 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
    Interventions:
    • Biological: histamine
    • Biological: sham
  • 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
    Interventions:
    • Biological: histamine
    • Biological: sham
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
16
October 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact: Ina Callebaut, PhD, fellow ina.callebaut@med.kuleuven.be
Contact: Emily Dekimpe, Msc emily.dekimpe@uzleuven.be
Belgium
 
NCT01777464
september2012
No
Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
Not Provided
Principal Investigator: Peter Hellings, Dr KU Leuven
Universitaire Ziekenhuizen Leuven
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP