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.

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Key information

Conditions

Idiopathic Rhinitis Patients Healthy Controls

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UZ Leuven, NKO-GH Kapucijnenvoer 33

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with persistent (> 12w) rhinological symptoms: nasal discharge, sneezing, congestion for an average of at least 1 h per day for at least 5 days during a period of 14 days, negative skin prick test or negative RAST, and without structural abnormalities explaining nasal obstruction will be proposed to participate in the trial.
Age > 18 and < 50 years
Written informed consent
Willingness to adhere to visit schedules
Adequate contraceptive precautions in female patients with childbearing potential
Unresponsiveness to nasal steroid spray (4 weeks of use)

Exclusion criteria

Age < 18 and > 50 years
Patients with AR, demonstrated by either positive skin prick test or RAST
Presence of IgE in nasal lavage fluid
Structural abnormalities: nasal polyps, severe septal deviation (septum reaching concha inferior or lateral nasal wall.
Systemic steroid treatment less than 4 weeks before the inclusion in the study.
Nasal steroid spray less than 4 weeks before the inclusion, oral leukotriene antagonists or long-acting antihistamines less than 2 weeks before the inclusion.
Inability of the patient to stop taking medication affecting nasal function.
Evidence of infectious rhinitis/rhinosinusitis.
Pregnancy or breastfeeding.
Any disorder of which might compromise the ability of a patient to give truly informed consent for participation in this study.
Enrollment in other investigational drug trial(s) or is receiving other investigational agent(s) for any other medical condition.
Contra-indications for local anaesthesia (Cocaïne 5%).
Smoking.
Systemic disease with lesions in ENT domain.
Malignancies or severe comorbidity.

Treatment and study plan

Capsaicin

Drug

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

Primary outcomes

Neuro-immunological effect.

Time frame: 6 months

The primary aim of the study is to identify the neuro-immunological effects induced by capsaicin nasal spray in IR patients and healthy individuals.

Secondary outcomes

TR-PNIF-CDA

Time frame: 7 months

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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Oct 19, 2010
Registry last updated: Oct 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed