The Prevalence of Local Immunoglobulin E (IgE) Elevation and Its Effect on Intranasal Capsaicin Therapy in the Non-allergic Rhinitis Population

Study Overview
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Brief Summary
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The purpose of this study to determine the therapeutic response of non-allergic rhinitis patients that have been subtyped as non-allergic rhinitis with local IgE elevation or non-allergic rhinopathy to intranasal capsaicin based on visual analog scale and optical rhinometry, to determine the prevalence of non-allergic rhinitis with local IgE elevation in this study's cohort of patients with non-allergic rhinitis identified by rhinitis history and negative skin testing for allergic rhinitis, and to determine the change, if any, in intranasal IgE levels after capsaicin treatment.

Official Title
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The Prevalence of Local IgE Elevation and Its Effect on Intranasal Capsaicin Therapy in the Non-allergic Rhinitis Population

Conditions
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Non-allergic Rhinitis

Intervention / Treatment
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* Drug: Intranasal capsaicin
* Drug: topical lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic rhinitis Exclusion Criteria: Active smoker Anatomic source of nasal symptoms Chronic rhinosinusitis or other nasal infection History of sinonasal malignancy Pregnancy or lactation Use of medication affecting nasal function (topical steroids, topical anticholinergics, oral antihistamines) in the previous 4 weeks Use or abuse of nasal decongestants. Positive skin prick test for allergic rhinitis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Drug: Intranasal capsaicin<br>* Intranasal capsaicin, 5 applications each delivering 2 micrograms in each nostril, separated by 1 hour.<br>Drug: topical lidocaine<br>* The nose will be pre-treated with topical lidocaine 15 minutes before each application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in nasal symptoms of rhinorrhea as measured by the visual analog scale (VAS) | Results range from 0-10, higher number indicating a worse outcome | baseline, 4 weeks post treatment, 12 weeks post treatment | 
| Change in nasal obstruction as measured by the visual analog scale (VAS) | Results range from 0-10, higher number indicating a worse outcome | baseline, 4 weeks post treatment, 12 weeks post treatment | 
| Change in nasal itching as measured by the visual analog scale (VAS) | Results range from 0-10, higher number indicating a worse outcome | baseline, 4 weeks post treatment, 12 weeks post treatment | 
| Change in nasal sneezing as measured by the visual analog scale (VAS) | Results range from 0-10, higher number indicating a worse outcome | baseline, 4 weeks post treatment, 12 weeks post treatment | 
| Change in maximum optical density determined via optical rhinometry |  | baseline, 12 weeks post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in local IgE level | The IgE levels will be obtained from the brush biopsy of the inferior turbinates | baseline, 12 weeks post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rhinorrhea, congestion, sneezing, itching