MedTrace Logo

Neuro-immunological Analysis of Idiopathic Rhinitis Patients and Controls Treated With Capsaicin.

NCT01223820 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2011-10-03

No results posted yet for this study

Summary

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.

Conditions

  • Idiopathic Rhinitis Patients
  • Healthy Controls

Interventions

DRUG

Capsaicin

5x nasal application in one day, 1 hour between each application

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Laura H Van Gerven, MD · UZ Leuven

  • Peter W Hellings, MD, PhD · UZ Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01223820 on ClinicalTrials.gov