Back to resultsRole of the Central Nervous System in Allergic Rhinitis
Primary Purpose
House Dust Mite Allergy
Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
histamine
sham
Sponsored by
About this trial
This is an interventional basic science trial for House Dust Mite Allergy
Eligibility 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
Sites / Locations
- uz leuven ORL
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
patients
healthy controls
Arm 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
healthy controls receive sham solution for 5 minutes on first visit and histamine (16mg/ml) for 5 minutes on second visit
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01777464
First Posted
January 23, 2013
Last Updated
December 2, 2015
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT01777464
Brief Title
Role of the Central Nervous System in Allergic Rhinitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Terminated
Why Stopped
analysing images ongoing
Study Start Date
November 2012 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
Evaluate the effects a nasal provocation on the activation of different brain regions
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
House Dust Mite Allergy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients
Arm Type
Experimental
Arm 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
Arm Title
healthy controls
Arm Type
Sham Comparator
Arm Description
healthy controls receive sham solution for 5 minutes on first visit and histamine (16mg/ml) for 5 minutes on second visit
Intervention Type
Biological
Intervention Name(s)
histamine
Intervention Description
administration of histamine solution (16 mg/ml) via aerosol for 5 minutes while lying under a fMRI scan
Intervention Type
Biological
Intervention Name(s)
sham
Intervention Description
sham solution
Primary Outcome Measure Information:
Title
brain activation
Description
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.
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
nasal symptoms and Peak Nasal Inspiratory Flow
Description
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
Time Frame
before and after scans
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Hellings, Dr
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
uz leuven ORL
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
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Role of the Central Nervous System in Allergic Rhinitis
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