Role of the Central Nervous System in Allergic Rhinitis

U

Universitaire Ziekenhuizen KU Leuven

Status

Terminated

Conditions

House Dust Mite Allergy

Treatments

Biological: histamine
Biological: sham

Study type

Interventional

Funder types

Other

Identifiers

NCT01777464
september2012

Details and patient eligibility

About

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.

Full description

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

Enrollment

14 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

14 participants in 2 patient groups

patients
Experimental group
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
Treatment:
Biological: sham
Biological: histamine
healthy controls
Sham Comparator group
Description:
healthy controls receive sham solution for 5 minutes on first visit and histamine (16mg/ml) for 5 minutes on second visit
Treatment:
Biological: sham
Biological: histamine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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