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Role of the Central Nervous System in Allergic Rhinitis

NCT ID: NCT01777464

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2016-03-31

Brief Summary

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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

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

Conditions

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House Dust Mite Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

histamine

Intervention Type BIOLOGICAL

administration of histamine solution (16 mg/ml) via aerosol for 5 minutes while lying under a fMRI scan

sham

Intervention Type BIOLOGICAL

sham solution

healthy controls

healthy controls receive sham solution for 5 minutes on first visit and histamine (16mg/ml) for 5 minutes on second visit

Group Type SHAM_COMPARATOR

histamine

Intervention Type BIOLOGICAL

administration of histamine solution (16 mg/ml) via aerosol for 5 minutes while lying under a fMRI scan

sham

Intervention Type BIOLOGICAL

sham solution

Interventions

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histamine

administration of histamine solution (16 mg/ml) via aerosol for 5 minutes while lying under a fMRI scan

Intervention Type BIOLOGICAL

sham

sham solution

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Hellings, Dr

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

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uz leuven ORL

Leuven, Vlaams Brabant, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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september2012

Identifier Type: -

Identifier Source: org_study_id