NCT01777464

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

December 3, 2015

Status Verified

September 1, 2014

Enrollment Period

3.3 years

First QC Date

January 23, 2013

Last Update Submit

December 2, 2015

Conditions

House Dust Mite Allergy

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 minutes

Secondary Outcomes (1)

  • nasal symptoms and Peak Nasal Inspiratory Flow

    before and after scans

Study Arms (2)

patients

EXPERIMENTAL

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

Biological: histamineBiological: sham

healthy controls

SHAM COMPARATOR

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

Biological: histamineBiological: sham

Interventions

histamineBIOLOGICAL

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

healthy controlspatients
shamBIOLOGICAL

sham solution

healthy controlspatients

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Current or recent (finished less than 2 years) immunotherapy against grass pollen.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

uz leuven ORL

Leuven, Vlaams Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Dust Mite Allergy

Interventions

Histaminesalicylhydroxamic acid

Condition Hierarchy (Ancestors)

Rhinitis, Allergic, PerennialRhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Biogenic MonoaminesBiogenic AminesAminesOrganic ChemicalsEthylaminesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Peter Hellings, Dr

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2013

First Posted

January 28, 2013

Study Start

November 1, 2012

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

December 3, 2015

Record last verified: 2014-09

Locations

BE(1)