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

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ClinicalTrials.gov Identifier: NCT01223820
Recruitment Status : Completed
First Posted : October 19, 2010
Last Update Posted : October 3, 2011
Information provided by (Responsible Party):
Laura Van Gerven, Universitaire Ziekenhuizen Leuven

Brief 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.

Condition or disease Intervention/treatment Phase
Idiopathic Rhinitis Patients Healthy Controls Drug: Capsaicin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neuro-immunological Analysis of Idiopathic Rhinitis Patients and Controls Treated With Capsaicin.
Study Start Date : January 2011
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Capsaicin Drug: Capsaicin
5x nasal application in one day, 1 hour between each application

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01223820

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

Responsible Party: Laura Van Gerven, MD, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01223820     History of Changes
Other Study ID Numbers: Nasal Capsaicin treatment
First Posted: October 19, 2010    Key Record Dates
Last Update Posted: October 3, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs