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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laura Van Gerven, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01223820
First received: October 18, 2010
Last updated: September 30, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Idiopathic Rhinitis Patients
Healthy Controls
Drug: Capsaicin
Phase 4

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 36
Study Start Date: January 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Capsaicin Drug: Capsaicin
5x nasal application in one day, 1 hour between each application

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. Age > 18 and < 50 years
  3. Written informed consent
  4. Willingness to adhere to visit schedules
  5. Adequate contraceptive precautions in female patients with childbearing potential
  6. Unresponsiveness to nasal steroid spray (4 weeks of use)

Exclusion Criteria:

  1. Age < 18 and > 50 years
  2. Patients with AR, demonstrated by either positive skin prick test or RAST
  3. Presence of IgE in nasal lavage fluid
  4. Structural abnormalities: nasal polyps, severe septal deviation (septum reaching concha inferior or lateral nasal wall.
  5. Systemic steroid treatment less than 4 weeks before the inclusion in the study.
  6. Nasal steroid spray less than 4 weeks before the inclusion, oral leukotriene antagonists or long-acting antihistamines less than 2 weeks before the inclusion.
  7. Inability of the patient to stop taking medication affecting nasal function.
  8. Evidence of infectious rhinitis/rhinosinusitis.
  9. Pregnancy or breastfeeding.
  10. Any disorder of which might compromise the ability of a patient to give truly informed consent for participation in this study.
  11. Enrollment in other investigational drug trial(s) or is receiving other investigational agent(s) for any other medical condition.
  12. Contra-indications for local anaesthesia (Cocaïne 5%).
  13. Smoking.
  14. Systemic disease with lesions in ENT domain.
  15. Malignancies or severe comorbidity.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01223820

Locations
Belgium
UZ Leuven, NKO-GH Kapucijnenvoer 33
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Laura H Van Gerven, MD UZ Leuven
Study Director: Peter W Hellings, MD, PhD UZ Leuven
  More Information

No publications provided

Responsible Party: Laura Van Gerven, MD, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01223820     History of Changes
Other Study ID Numbers: Nasal Capsaicin treatment
Study First Received: October 18, 2010
Last Updated: September 30, 2011
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Capsaicin
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2014