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CompletedNCT05093478Updated Dec 20, 2024Results posted

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

A Phase 3 interventional study of Intranasal capsaicin and topical lidocaine in Non-allergic Rhinitis, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-20.

Sponsored by The University of Texas Health Science Center, Houston · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Sep 2019, registered Oct 2021).
Phase
Phase 3
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Non-allergic Rhinitis

Keywords

  • rhinorrhea
  • congestion
  • sneezing
  • itching
03

In context

Common Cold

219 studies on the registry are indexed under Common Cold; 23 are open to participants now.

This study's enrollment of 28 is below the median of 150 across 184 interventional studies indexed under Common Cold.

Browse Common Cold studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.

Browse The University of Texas Health Science Center, Houston studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Chronic rhinitis

Exclusion criteria

Exclusion Criteria:

  • Active smoker
  • Anatomic source of nasal symptoms
  • Chronic rhinosinusitis or other nasal infection
  • History of sinonasal
  • Pregnancy or lactation
  • Use of medication affecting nasal function (topical , topical anticholinergics, oral antihistamines) in the previous 4 weeks
  • Use or abuse of nasal decongestants.
  • Positive skin prick test for allergic rhinitis
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Treatment

    Drug: Intranasal capsaicin · Drug: topical lidocaine

Interventions

  • DrugIntranasal capsaicin

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

  • Drugtopical lidocaine

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline

  2. 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.

    Time frame: 4 weeks post treatment

  3. 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.

    Time frame: 12 weeks post treatment

  4. 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.

    Time frame: baseline

  5. 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.

    Time frame: 4 weeks post treatment

  6. 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.

    Time frame: 12 weeks post treatment

  7. 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.

    Time frame: baseline

  8. 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.

    Time frame: 4 weeks post treatment

  9. 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.

    Time frame: 12 weeks post treatment

  10. 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.

    Time frame: baseline

  11. 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.

    Time frame: 4 weeks post treatment

  12. 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.

    Time frame: 12 weeks post treatment

  13. 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.

    Time frame: baseline, immediately post first treatment on Day 1

  14. 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.

    Time frame: baseline

  15. 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.

    Time frame: 4 weeks post treatment

  16. 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.

    Time frame: 12 weeks post treatment

  17. Maximum Optical Density Determined Via Optical Rhinometry

    Time frame: 12 weeks post treatment

Secondary outcomes

  1. Change in Local Immunoglobulin E (IgE) Level

    The IgE levels will be obtained from the brush biopsy of the inferior turbinates. Change from baseline in local Immunoglobulin E (IgE) level after 12 weeks post treatment. Data reported is the 12 weeks post treatment value minus the baseline value.

    Time frame: baseline, 12 weeks post treatment

07

Results

Posted Dec 20, 2024

Participant flow

Participant flow — Overall Study
MilestoneTreatment
Started28
Completed24
Not completed4

Outcome measures

PrimaryRunny 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.

Time frame:
baseline
Reported as:
Mean · score on a scale
Runny Nose as Measured by the Visual Analog Scale (VAS) at Baseline
score on a scaleTreatment
Runny Nose as Measured by the Visual Analog Scale (VAS) at Baseline6.07 ± 2.41
PrimaryRunny 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.

Time frame:
4 weeks post treatment
Reported as:
Mean · score on a scale
Runny Nose as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
score on a scaleTreatment
Runny Nose as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment2.89 ± 2.04
PrimaryRunny 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.

Time frame:
12 weeks post treatment
Reported as:
Mean · score on a scale
Runny Nose as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
score on a scaleTreatment
Runny Nose as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment3.75 ± 3.15
PrimaryNasal 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.

Time frame:
baseline
Reported as:
Mean · score on a scale
Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at Baseline
score on a scaleTreatment
Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at Baseline5.57 ± 2.80
PrimaryNasal 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.

Time frame:
4 weeks post treatment
Reported as:
Mean · score on a scale
Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
score on a scaleTreatment
Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment2.46 ± 2.13
PrimaryNasal 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.

Time frame:
12 weeks post treatment
Reported as:
Mean · score on a scale
Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
score on a scaleTreatment
Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment2.75 ± 2.13
PrimaryNasal 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.

Time frame:
baseline
Reported as:
Mean · score on a scale
Nasal Itching as Measured by the Visual Analog Scale (VAS at Baseline
score on a scaleTreatment
Nasal Itching as Measured by the Visual Analog Scale (VAS at Baseline2.25 ± 2.60
PrimaryNasal 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.

Time frame:
4 weeks post treatment
Reported as:
Mean · score on a scale
Nasal Itching as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
score on a scaleTreatment
Nasal Itching as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment1.50 ± 1.95
PrimaryNasal 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.

Time frame:
12 weeks post treatment
Reported as:
Mean · score on a scale
Nasal Itching as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
score on a scaleTreatment
Nasal Itching as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment1.20 ± 1.84
PrimaryNasal 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.

Time frame:
baseline
Reported as:
Mean · score on a scale
Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at Baseline
score on a scaleTreatment
Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at Baseline3.03 ± 2.47
PrimaryNasal 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.

Time frame:
4 weeks post treatment
Reported as:
Mean · score on a scale
Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
score on a scaleTreatment
Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment1.71 ± 2.07
PrimaryNasal 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.

Time frame:
12 weeks post treatment
Reported as:
Mean · score on a scale
Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
score on a scaleTreatment
Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment2.29 ± 2.91
PrimaryChange 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.

Time frame:
baseline, immediately post first treatment on Day 1
Reported as:
Mean · log ratio of light in to light out (OD)
Change in Maximum Optical Density Determined Via Optical Rhinometry
log ratio of light in to light out (OD)Treatment
Change in Maximum Optical Density Determined Via Optical Rhinometry0.36 ± 0.18
PrimaryTotal 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.

Time frame:
baseline
Reported as:
Mean · score on a scale
Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at Baseline
score on a scaleTreatment
Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at Baseline16.92 ± 7.03
PrimaryTotal 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.

Time frame:
4 weeks post treatment
Reported as:
Mean · score on a scale
Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
score on a scaleTreatment
Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment8.57 ± 6.69
PrimaryTotal 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.

Time frame:
12 weeks post treatment
Reported as:
Mean · score on a scale
Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
score on a scaleTreatment
Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment10 ± 7.78
SecondaryChange in Local Immunoglobulin E (IgE) Level

The IgE levels will be obtained from the brush biopsy of the inferior turbinates. Change from baseline in local Immunoglobulin E (IgE) level after 12 weeks post treatment. Data reported is the 12 weeks post treatment value minus the baseline value.

Time frame:
baseline, 12 weeks post treatment
Reported as:
Mean · kU/L
Change in Local Immunoglobulin E (IgE) Level
kU/LTreatment
Change in Local Immunoglobulin E (IgE) Level0.17 ± 1.57
PrimaryMaximum Optical Density Determined Via Optical Rhinometry
Time frame:
12 weeks post treatment

No measurements were reported for this outcome.

Adverse events

Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment0/28 (0%)0/28 (0%)0/28 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Treatment
Mean62.59 ± 16.96
Sex: Female, Male
Sex: Female, Male(Participants)Treatment
Female15
Male13
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Treatment
Region of Enrollment
Region of Enrollment(participants)Treatment
United States28
08

Study locations

1 site
  • The University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2019 to primary completion in Nov 2023, 50 months.

Results were first posted in Dec 2024, 1 year after primary completion.

Of 17 phase 3 interventional studies under Common Cold, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 16. This study's 50 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 14, 2021
First posted
Oct 26, 2021
StartActual
Sep 10, 2019
Primary completionActual
Nov 30, 2023
CompletionActual
Nov 30, 2023
Results first posted
Dec 20, 2024
Last update
Dec 20, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05093478
Lead sponsor
The University of Texas Health Science Center, Houston
Collaborators
American Academy of Otolaryngic Allergy
Responsible party
Kunal R. Shetty (Otolaryngology Resident, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Oct 26, 2021
Start date
Sep 10, 2019
Primary completion
Nov 30, 2023
Completion
Nov 30, 2023
Results posted
Dec 20, 2024
Last update
Dec 20, 2024

Study contacts

Kunal R Shetty, MD
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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