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

October 18, 2010
September 30, 2011
January 2011
September 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01223820 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Neuro-immunological Analysis of Idiopathic Rhinitis Patients and Controls Treated With Capsaicin.
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Idiopathic Rhinitis Patients
  • Healthy Controls
Drug: Capsaicin
5x nasal application in one day, 1 hour between each application
Experimental: Capsaicin
Intervention: Drug: Capsaicin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
September 2011
September 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01223820
Nasal Capsaicin treatment
Yes
Laura Van Gerven, Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
Not Provided
Principal Investigator: Laura H Van Gerven, MD UZ Leuven
Study Director: Peter W Hellings, MD, PhD UZ Leuven
Universitaire Ziekenhuizen Leuven
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP