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

Primary Purpose

Non-allergic Rhinitis

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Intranasal capsaicin
topical lidocaine
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-allergic Rhinitis focused on measuring rhinorrhea, congestion, sneezing, itching

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Outcomes

Primary Outcome Measures

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
Change in nasal obstruction as measured by the visual analog scale (VAS)
Results range from 0-10, higher number indicating a worse outcome
Change in nasal itching as measured by the visual analog scale (VAS)
Results range from 0-10, higher number indicating a worse outcome
Change in nasal sneezing as measured by the visual analog scale (VAS)
Results range from 0-10, higher number indicating a worse outcome
Change in maximum optical density determined via optical rhinometry

Secondary Outcome Measures

Change in local IgE level
The IgE levels will be obtained from the brush biopsy of the inferior turbinates

Full Information

First Posted
October 14, 2021
Last Updated
May 11, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
American Academy of Otolaryngic Allergy & Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05093478
Brief Title
The Prevalence of Local Immunoglobulin E (IgE) Elevation and Its Effect on Intranasal Capsaicin Therapy in the Non-allergic Rhinitis Population
Official Title
The Prevalence of Local IgE Elevation and Its Effect on Intranasal Capsaicin Therapy in the Non-allergic Rhinitis Population
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 10, 2019 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
American Academy of Otolaryngic Allergy & Foundation

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-allergic Rhinitis
Keywords
rhinorrhea, congestion, sneezing, itching

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Intranasal capsaicin
Intervention Description
Intranasal capsaicin, 5 applications each delivering 2 micrograms in each nostril, separated by 1 hour.
Intervention Type
Drug
Intervention Name(s)
topical lidocaine
Intervention Description
The nose will be pre-treated with topical lidocaine 15 minutes before each application
Primary Outcome Measure Information:
Title
Change in nasal symptoms of rhinorrhea as measured by the visual analog scale (VAS)
Description
Results range from 0-10, higher number indicating a worse outcome
Time Frame
baseline, 4 weeks post treatment, 12 weeks post treatment
Title
Change in nasal obstruction as measured by the visual analog scale (VAS)
Description
Results range from 0-10, higher number indicating a worse outcome
Time Frame
baseline, 4 weeks post treatment, 12 weeks post treatment
Title
Change in nasal itching as measured by the visual analog scale (VAS)
Description
Results range from 0-10, higher number indicating a worse outcome
Time Frame
baseline, 4 weeks post treatment, 12 weeks post treatment
Title
Change in nasal sneezing as measured by the visual analog scale (VAS)
Description
Results range from 0-10, higher number indicating a worse outcome
Time Frame
baseline, 4 weeks post treatment, 12 weeks post treatment
Title
Change in maximum optical density determined via optical rhinometry
Time Frame
baseline, 12 weeks post treatment
Secondary Outcome Measure Information:
Title
Change in local IgE level
Description
The IgE levels will be obtained from the brush biopsy of the inferior turbinates
Time Frame
baseline, 12 weeks post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kunal R Shetty, MD
Phone
(713) 486-5000
Email
Kunal.R.Shetty@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amber Luong, MD
Phone
(713) 500-5410
Email
Amber.U.Luong@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kunal R Shetty, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kunal R Shetty, MD
Phone
713-486-5000
Email
Kunal.R.Shetty@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Amber Luong, MD
Phone
(713) 500-5410
Email
Amber.U.Luong@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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