Non-allergic Rhinitis
Conditions
Keywords
rhinorrhea, congestion, sneezing, itching
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.
Interventions
Intranasal capsaicin, 5 applications each delivering 2 micrograms in each nostril, separated by 1 hour.
The nose will be pre-treated with topical lidocaine 15 minutes before each application
Sponsors
American Academy of Otolaryngic Allergy
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Optical Density Determined Via Optical Rhinometry | 12 weeks post treatment | — |
| Runny Nose as Measured by the Visual Analog Scale (VAS) at Baseline | baseline | The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable. |
| Runny Nose as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment | 4 weeks post treatment | The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable. |
| Runny Nose as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment | 12 weeks post treatment | The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable. |
| Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at Baseline | baseline | The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable. |
| Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment | 4 weeks post treatment | The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable. |
| Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment | 12 weeks post treatment | The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable. |
| Nasal Itching as Measured by the Visual Analog Scale (VAS at Baseline | baseline | The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable. |
| Nasal Itching as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment | 4 weeks post treatment | The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable. |
| Nasal Itching as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment | 12 weeks post treatment | The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable. |
| Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at Baseline | baseline | The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable. |
| Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment | 4 weeks post treatment | The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable. |
| Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment | 12 weeks post treatment | The Visual analog scale is scored from 0-10, with 0 being not a problem and 10 being unbearable. |
| Change in Maximum Optical Density Determined Via Optical Rhinometry | 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. |
| Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at Baseline | 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. |
| Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment | 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. |
| Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Local Immunoglobulin E (IgE) Level | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment 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 | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | Treatment | — |
|---|---|---|
| Age, Continuous | 62.59 years STANDARD_DEVIATION 16.96 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 28 participants | — |
| Sex: Female, Male Female | 15 Participants | — |
| Sex: Female, Male Male | 13 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
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
Population: Data were not collected for 6 participants in the treatment arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Change in Maximum Optical Density Determined Via Optical Rhinometry | 0.36 log ratio of light in to light out (OD) | Standard Deviation 0.18 |
Primary
Maximum Optical Density Determined Via Optical Rhinometry
Time frame: 12 weeks post treatment
Population: Data were not collected for this outcome measure.
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Nasal Itching as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment | 1.20 score on a scale | Standard Deviation 1.84 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Nasal Itching as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment | 1.50 score on a scale | Standard Deviation 1.95 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Nasal Itching as Measured by the Visual Analog Scale (VAS at Baseline | 2.25 score on a scale | Standard Deviation 2.6 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment | 2.29 score on a scale | Standard Deviation 2.91 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment | 1.71 score on a scale | Standard Deviation 2.07 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at Baseline | 3.03 score on a scale | Standard Deviation 2.47 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment | 2.75 score on a scale | Standard Deviation 2.13 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment | 2.46 score on a scale | Standard Deviation 2.13 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at Baseline | 5.57 score on a scale | Standard Deviation 2.8 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Runny Nose as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment | 3.75 score on a scale | Standard Deviation 3.15 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Runny Nose as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment | 2.89 score on a scale | Standard Deviation 2.04 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Runny Nose as Measured by the Visual Analog Scale (VAS) at Baseline | 6.07 score on a scale | Standard Deviation 2.41 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment | 10 score on a scale | Standard Deviation 7.78 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment | 8.57 score on a scale | Standard Deviation 6.69 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at Baseline | 16.92 score on a scale | Standard Deviation 7.03 |
Secondary
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
Population: Data were not collected for 5 participants in the Treatment arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Change in Local Immunoglobulin E (IgE) Level | 0.17 kU/L | Standard Deviation 1.57 |