Role of the Central Nervous System in Allergic Rhinitis

House Dust Mite Allergy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01777464
• Other study ID #: september2012
• Status: Terminated
• Phase: N/A
• First received: January 23, 2013
• Last updated: December 2, 2015
• Start date: November 2012
• Est. completion date: March 2016

Study information

• Verified date: September 2014
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• House Dust Mite Allergy

Intervention

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

Locations

Country	Name	City	State
Belgium	uz leuven ORL	Leuven	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	before and after scans	No