Neuro-immunological Analysis of Idiopathic Rhinitis Patients and Controls Treated With Capsaicin.
The term idiopathic rhinitis (IR) is used in this study to describe a patient group with following characteristics: patients with complaints of nasal obstruction, sneezing and/or rhinorrhea for a period of over 1 year, which cannot be attributed to allergy, nasal or paranasal infection, anatomical disorders, pregnancy or lactation and/or systemic disorders. These patients are non-smokers and do not use medication affecting nasal function. They have no beneficial effect of intranasal steroid spray (INS) treatment.
The population incidence of IR is estimated to be as high as 10%. The pathophysiology of IR is largely unknown. Several hypotheses have been put forward. In general it is assumed that neurogenic mechanisms play an important role. Neuropeptides like CGRP, SP, NKA/B, NPY, NGF are released from afferent neurons in the nasal mucosa after activation by unspecific stimuli and can be responsible for the symptoms of IR.
For this group of IR-patients, there is until now only one treatment option: intranasal capsaicin application. Capsaicin, the pungent agent in hot pepper, is supposed to exert its' therapeutic effect via degeneration or desensitization effect on the afferent C-fibers.
The hypothesis is that nasal capsaicin treatment reduces neurogenic inflammation and reduces in that way nasal symptoms.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Neuro-immunological Analysis of Idiopathic Rhinitis Patients and Controls Treated With Capsaicin.|
- Neuro-immunological effect. [ Time Frame: 6 months ] [ Designated as safety issue: No ]The primary aim of the study is to identify the neuro-immunological effects induced by capsaicin nasal spray in IR patients and healthy individuals.
- TR-PNIF-CDA [ Time Frame: 7 months ] [ Designated as safety issue: No ]The secondary aim of this study is to correlate the neuro-immunological findings with the therapeutic response to capsaicin, the nasal congestion using the peak nasal inspiratory (PNIF), and nasal response to Cold Dry Air (CDA)-provocation.
|Study Start Date:||January 2011|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
5x nasal application in one day, 1 hour between each application
Please refer to this study by its ClinicalTrials.gov identifier: NCT01223820
|UZ Leuven, NKO-GH Kapucijnenvoer 33|
|Leuven, Vlaams-Brabant, Belgium, 3000|
|Principal Investigator:||Laura H Van Gerven, MD||UZ Leuven|
|Study Director:||Peter W Hellings, MD, PhD||UZ Leuven|