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

Phase 3

Completed

Conditions: Non-allergic Rhinitis

Interventions: Drug: Intranasal capsaicin
Drug: topical lidocaine

Registration Number: NCT05093478

Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 28

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	topical lidocaine	-
Treatment	Intranasal capsaicin	-

Primary Outcome Measures

Name	Time	Method
Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at Baseline	baseline	The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment	4 weeks post treatment	The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment	12 weeks post treatment	The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Runny Nose as Measured by the Visual Analog Scale (VAS) at Baseline	baseline	The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Runny Nose as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment	4 weeks post treatment	The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Runny Nose as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment	12 weeks post treatment	The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Nasal Itching as Measured by the Visual Analog Scale (VAS at Baseline	baseline	The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Nasal Itching as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment	4 weeks post treatment	The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Nasal Itching as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment	12 weeks post treatment	The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at Baseline	baseline	The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment	4 weeks post treatment	The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment	12 weeks post treatment	The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
Change in Maximum Optical Density Determined Via Optical Rhinometry	baseline, immediately post first treatment on Day 1	Optical rhinometry provides continuous measurement of blood flow in nasal vessels (via optical density measurements), which serves as an indirect assessment of nasal congestion. A greater decrease in optical density (OD) from baseline indicates less nasal blood flow and decreased congestion relative to baseline.
Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at Baseline	baseline	Total Nasal Symptom score is measured as the sum of four symptom scores for runny nose, nasal symptoms of congestion, nasal itching and sneezing. Each symptom is scored from 0-10, with 0 being not a problem and 10 being unbearable. The Total nasal symptom score ranges from 0 - 40, the lower the score the better the outcome.
Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment	4 weeks post treatment	Total Nasal Symptom score is measured as the sum of four symptom scores for runny nose, nasal symptoms of congestion, nasal itching and sneezing. Each symptom is scored from 0-10, with 0 being not a problem and 10 being unbearable. The Total nasal symptom score ranges from 0 - 40, the lower the score the better the outcome.
Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment	12 weeks post treatment	Total Nasal Symptom score is measured as the sum of four symptom scores for runny nose, nasal symptoms of congestion, nasal itching and sneezing. Each symptom is scored from 0-10, with 0 being not a problem and 10 being unbearable. The Total nasal symptom score ranges from 0 - 40, the lower the score the better the outcome.
Maximum Optical Density Determined Via Optical Rhinometry	12 weeks post treatment

Secondary Outcome Measures

Name	Time	Method
Change in Local Immunoglobulin E (IgE) Level	baseline, 12 weeks post treatment	The IgE levels will be obtained from the brush biopsy of the inferior turbinates. Change from baseline in local Immunoglobulin E (IgE) level after 12 weeks post treatment. Data reported is the 12 weeks post treatment value minus the baseline value.