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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
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
The University of Texas Health Science Center at Houston
Houston, Texas, United States
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Maximum Optical Density Determined Via Optical Rhinometry
Time frame: 12 weeks post treatment
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
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