NCT05093478

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2019

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 20, 2024

Completed
Last Updated

December 20, 2024

Status Verified

November 1, 2024

Enrollment Period

4.2 years

First QC Date

October 14, 2021

Results QC Date

November 27, 2024

Last Update Submit

November 27, 2024

Conditions

Non-allergic Rhinitis

Keywords

rhinorrheacongestionsneezingitching

Outcome Measures

Primary Outcomes (17)

  • Runny Nose as Measured by the Visual Analog Scale (VAS) at 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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    12 weeks post treatment

Secondary Outcomes (1)

  • Change in Local Immunoglobulin E (IgE) Level

    baseline, 12 weeks post treatment

Study Arms (1)

Treatment

EXPERIMENTAL
Drug: Intranasal capsaicinDrug: topical lidocaine

Interventions

Intranasal capsaicinDRUG

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

Treatment
topical lidocaineDRUG

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

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic rhinitis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Common ColdRhinorrheaSneezingPruritus

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsSkin DiseasesSkin and Connective Tissue DiseasesSkin Manifestations

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Kunal R Shetty, MD
Organization
The University of Texas Health Science Center at Houston
Kunal.R.Shetty@uth.tmc.edu
713-486-5000

Study Officials

  • Kunal R Shetty, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Otolaryngology Resident

Study Record Dates

First Submitted

October 14, 2021

First Posted

October 26, 2021

Study Start

September 10, 2019

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

December 20, 2024

Results First Posted

December 20, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)