Trial Outcomes & Findings for The Prevalence of Local Immunoglobulin E (IgE) Elevation and Its Effect on Intranasal Capsaicin Therapy in the Non-allergic Rhinitis Population (NCT NCT05093478)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

28 participants

Primary outcome timeframe

baseline

Results posted on

2024-12-20

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	28
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age was not collected from one participant in the treatment arm.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=28 Participants 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
Age, Continuous	62.59 years STANDARD_DEVIATION 16.96 • n=27 Participants • Age was not collected from one participant in the treatment arm.
Sex: Female, Male Female	15 Participants n=28 Participants
Sex: Female, Male Male	13 Participants n=28 Participants
Region of Enrollment United States	28 participants n=28 Participants

PRIMARY outcome

Timeframe: baseline

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

Outcome measures

Outcome measures
Measure	Treatment n=28 Participants 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
Runny Nose as Measured by the Visual Analog Scale (VAS) at Baseline	6.07 score on a scale Standard Deviation 2.41

PRIMARY outcome

Timeframe: 4 weeks post treatment

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

Outcome measures

Outcome measures
Measure	Treatment n=28 Participants 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
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 outcome

Timeframe: 12 weeks post treatment

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

Outcome measures

Outcome measures
Measure	Treatment n=24 Participants 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
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 outcome

Timeframe: baseline

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

Outcome measures

Outcome measures
Measure	Treatment n=28 Participants 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
Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at Baseline	5.57 score on a scale Standard Deviation 2.80

PRIMARY outcome

Timeframe: 4 weeks post treatment

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

Outcome measures

Outcome measures
Measure	Treatment n=28 Participants 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
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 outcome

Timeframe: 12 weeks post treatment

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

Outcome measures

Outcome measures
Measure	Treatment n=24 Participants 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
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 outcome

Timeframe: baseline

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

Outcome measures

Outcome measures
Measure	Treatment n=28 Participants 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
Nasal Itching as Measured by the Visual Analog Scale (VAS at Baseline	2.25 score on a scale Standard Deviation 2.60

PRIMARY outcome

Timeframe: 4 weeks post treatment

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

Outcome measures

Outcome measures
Measure	Treatment n=28 Participants 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
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 outcome

Timeframe: 12 weeks post treatment

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

Outcome measures

Outcome measures
Measure	Treatment n=24 Participants 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
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 outcome

Timeframe: baseline

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

Outcome measures

Outcome measures
Measure	Treatment n=28 Participants 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
Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at Baseline	3.03 score on a scale Standard Deviation 2.47

PRIMARY outcome

Timeframe: 4 weeks post treatment

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

Outcome measures

Outcome measures
Measure	Treatment n=28 Participants 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
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 outcome

Timeframe: 12 weeks post treatment

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

Outcome measures

Outcome measures
Measure	Treatment n=24 Participants 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
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 outcome

Timeframe: baseline, immediately post first treatment on Day 1

Population: Data were not collected for 6 participants in the treatment arm.

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.

Outcome measures

Outcome measures
Measure	Treatment n=22 Participants 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
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment n=28 Participants 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
Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at Baseline	16.92 score on a scale Standard Deviation 7.03

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment n=28 Participants 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
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment n=24 Participants 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
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 outcome

Timeframe: 12 weeks post treatment

Population: Data were not collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 12 weeks post treatment

Population: Data were not collected for 5 participants in the Treatment arm.

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.

Outcome measures

Outcome measures
Measure	Treatment n=19 Participants 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
Change in Local Immunoglobulin E (IgE) Level	0.17 kU/L Standard Deviation 1.57

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kunal R Shetty, MD

The University of Texas Health Science Center at Houston

Phone: 713-486-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place