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

November 27, 2024 updated by: Kunal R. Shetty, The University of Texas Health Science Center, Houston

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Runny Nose as Measured by the Visual Analog Scale (VAS) at Baseline
Time Frame: baseline
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
baseline
Runny Nose as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
Time Frame: 4 weeks post treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
4 weeks post treatment
Runny Nose as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
Time Frame: 12 weeks post treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
12 weeks post treatment
Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at Baseline
Time Frame: baseline
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
baseline
Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
Time Frame: 4 weeks post treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
4 weeks post treatment
Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
Time Frame: 12 weeks post treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
12 weeks post treatment
Nasal Itching as Measured by the Visual Analog Scale (VAS at Baseline
Time Frame: baseline
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
baseline
Nasal Itching as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
Time Frame: 4 weeks post treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
4 weeks post treatment
Nasal Itching as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
Time Frame: 12 weeks post treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
12 weeks post treatment
Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at Baseline
Time Frame: baseline
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
baseline
Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
Time Frame: 4 weeks post treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
4 weeks post treatment
Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
Time Frame: 12 weeks post treatment
The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.
12 weeks post treatment
Change in Maximum Optical Density Determined Via Optical Rhinometry
Time Frame: 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.
baseline, immediately post first treatment on Day 1
Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at Baseline
Time Frame: 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.
baseline
Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
Time Frame: 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.
4 weeks post treatment
Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
Time Frame: 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.
12 weeks post treatment
Maximum Optical Density Determined Via Optical Rhinometry
Time Frame: 12 weeks post treatment
12 weeks post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Local Immunoglobulin E (IgE) Level
Time Frame: 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.
baseline, 12 weeks post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

American Academy of Otolaryngic Allergy

Investigators

  • Principal Investigator: Kunal R Shetty, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2019

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

October 14, 2021

First Submitted That Met QC Criteria

October 25, 2021

First Posted (Actual)

October 26, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

November 27, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-19-0333

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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