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

Non-allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05093478
• Other study ID #: HSC-MS-19-0333
• Status: Recruiting
• Phase: Phase 3
• Start date: September 10, 2019
• Est. completion date: July 1, 2023

Study information

• Verified date: May 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Kunal R Shetty, MD
• Phone: (713) 486-5000
• Email: Kunal.R.Shetty[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Common Cold
• Non-allergic Rhinitis
• Rhinitis

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	American Academy of Otolaryngic Allergy & Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change in maximum optical density determined via optical rhinometry		baseline, 12 weeks post treatment
Secondary	Change in local IgE level	The IgE levels will be obtained from the brush biopsy of the inferior turbinates	baseline, 12 weeks post treatment