We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Role of the Central Nervous System in Allergic Rhinitis

This study has been terminated.
(analysing images ongoing)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01777464
First Posted: January 28, 2013
Last Update Posted: December 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
January 23, 2013
January 28, 2013
December 3, 2015
November 2012
February 2016   (Final data collection date for primary outcome measure)
brain activation [ Time Frame: 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.
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 ]
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
nasal symptoms and Peak Nasal Inspiratory Flow [ Time Frame: 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 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 (Participant)
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.
 
Terminated
14
March 2016
February 2016   (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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01777464
september2012
No
Not Provided
Not Provided
Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
Not Provided
Principal Investigator: Peter Hellings, Dr KU Leuven
Universitaire Ziekenhuizen Leuven
September 2014

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