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NCT Number: NCT05093478

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

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.

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Key information

Conditions

Non-allergic Rhinitis Common Cold Infections Pathological Conditions, Signs and Symptoms Picornaviridae Infections Pruritus RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Rhinorrhea Signs and Symptoms Signs and Symptoms, Respiratory Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases Sneezing Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intranasal capsaicin

Drug

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

Topical Lidocaine

Drug

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

Primary outcomes

  1. Runny Nose as Measured by the Visual Analog Scale (VAS) at Baseline

    Time frame: baseline

    The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.

  2. Runny Nose as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment

    Time frame: 4 weeks post treatment

    The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.

  3. Runny Nose as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment

    Time frame: 12 weeks post treatment

    The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.

  4. Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at Baseline

    Time frame: baseline

    The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.

  5. Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment

    Time frame: 4 weeks post treatment

    The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.

  6. Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment

    Time frame: 12 weeks post treatment

    The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.

  7. Nasal Itching as Measured by the Visual Analog Scale (VAS at Baseline

    Time frame: baseline

    The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.

  8. Nasal Itching as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment

    Time frame: 4 weeks post treatment

    The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.

  9. Nasal Itching as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment

    Time frame: 12 weeks post treatment

    The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.

  10. Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at Baseline

    Time frame: baseline

    The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.

  11. Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment

    Time frame: 4 weeks post treatment

    The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.

  12. Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment

    Time frame: 12 weeks post treatment

    The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable.

  13. Change in Maximum Optical Density Determined Via Optical Rhinometry

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

    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.

  14. Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at Baseline

    Time frame: 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.

  15. Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment

    Time frame: 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.

  16. Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment

    Time frame: 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.

  17. Maximum Optical Density Determined Via Optical Rhinometry

    Time frame: 12 weeks post treatment

Secondary outcomes

  1. Change in Local Immunoglobulin E (IgE) Level

    Time frame: baseline, 12 weeks post treatment

    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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • American Academy of Otolaryngic Allergy

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 26, 2021
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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