Phase 3 N=28 Treatment

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

Non-allergic Rhinitis

Bottom Line

View on ClinicalTrials.gov: NCT05093478 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2024

Primary outcome: Primary: Runny Nose as Measured by the Visual Analog Scale (VAS) at Baseline — 6.07 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Intranasal capsaicin (Drug); topical lidocaine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center, Houston
Primary completion: Nov 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Runny Nose as Measured by the Visual Analog Scale (VAS) at Baseline	6.07	—
PRIMARY Runny Nose as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment	2.89	—
PRIMARY Runny Nose as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment	3.75	—
PRIMARY Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at Baseline	5.57	—
PRIMARY Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment	2.46	—
PRIMARY Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment	2.75	—
PRIMARY Nasal Itching as Measured by the Visual Analog Scale (VAS at Baseline	2.25	—
PRIMARY Nasal Itching as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment	1.50	—
PRIMARY Nasal Itching as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment	1.20	—
PRIMARY Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at Baseline	3.03	—
PRIMARY Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment	1.71	—
PRIMARY Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment	2.29	—
PRIMARY Change in Maximum Optical Density Determined Via Optical Rhinometry	0.36	—
PRIMARY Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at Baseline	16.92	—
PRIMARY Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment	8.57	—
PRIMARY Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment	10	—
PRIMARY Maximum Optical Density Determined Via Optical Rhinometry	—	—
SECONDARY Change in Local Immunoglobulin E (IgE) Level	0.17	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05093478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.