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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

NCT ID: NCT05093478

Last Updated: 2024-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-10

Study Completion Date

2023-11-30

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.

Detailed Description

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Conditions

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Non-allergic Rhinitis

Keywords

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rhinorrhea congestion sneezing itching

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Group Type EXPERIMENTAL

Intranasal capsaicin

Intervention Type DRUG

Intranasal capsaicin, 5 applications each delivering 2 micrograms in each nostril, separated by 1 hour.

topical lidocaine

Intervention Type DRUG

The nose will be pre-treated with topical lidocaine 15 minutes before each application

Interventions

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Intranasal capsaicin

Intranasal capsaicin, 5 applications each delivering 2 micrograms in each nostril, separated by 1 hour.

Intervention Type DRUG

topical lidocaine

The nose will be pre-treated with topical lidocaine 15 minutes before each application

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Academy of Otolaryngic Allergy

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Kunal R. Shetty

Otolaryngology Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kunal R Shetty, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HSC-MS-19-0333

Identifier Type: -

Identifier Source: org_study_id