Back to resultsNeuro-immunological Analysis of Idiopathic Rhinitis Patients and Controls Treated With Capsaicin.
Primary Purpose
Idiopathic Rhinitis Patients, Healthy Controls
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Capsaicin
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Rhinitis Patients
Eligibility Criteria
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.
Sites / Locations
- UZ Leuven, NKO-GH Kapucijnenvoer 33
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Capsaicin
Arm Description
Outcomes
Primary Outcome Measures
Neuro-immunological effect.
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
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.
Full Information
NCT ID
NCT01223820
First Posted
October 18, 2010
Last Updated
September 30, 2011
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT01223820
Brief Title
Neuro-immunological Analysis of Idiopathic Rhinitis Patients and Controls Treated With Capsaicin.
Official Title
Neuro-immunological Analysis of Idiopathic Rhinitis Patients and Controls Treated With Capsaicin.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Rhinitis Patients, Healthy Controls
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Capsaicin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Capsaicin
Intervention Description
5x nasal application in one day, 1 hour between each application
Primary Outcome Measure Information:
Title
Neuro-immunological effect.
Description
The primary aim of the study is to identify the neuro-immunological effects induced by capsaicin nasal spray in IR patients and healthy individuals.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
TR-PNIF-CDA
Description
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.
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura H Van Gerven, MD
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter W Hellings, MD, PhD
Organizational Affiliation
UZ Leuven
Official's Role
Study Director
Facility Information:
Facility Name
UZ Leuven, NKO-GH Kapucijnenvoer 33
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Neuro-immunological Analysis of Idiopathic Rhinitis Patients and Controls Treated With Capsaicin.
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