Clinical trial NCT05093478: The Prevalence of Local Immunoglobulin E (IgE) Elevation and Its Effect on Intranasal Capsaicin Therapy in the Non-allergic Rhinitis Population
Official title: The Prevalence of Local IgE Elevation and Its Effect on Intranasal Capsaicin Therapy in the Non-allergic Rhinitis Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-allergic Rhinitis
Keywords: rhinorrhea
congestion
sneezing
itching
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: American Academy of Otolaryngic Allergy
First posted: 2021-10-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Runny Nose as Measured by the Visual Analog Scale (VAS) at Baseline
timeFrame: baseline
measure: Runny Nose as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
timeFrame: 4 weeks post treatment
measure: Runny Nose as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
timeFrame: 12 weeks post treatment
measure: Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at Baseline
timeFrame: baseline
measure: Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
timeFrame: 4 weeks post treatment
measure: Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
timeFrame: 12 weeks post treatment
measure: Nasal Itching as Measured by the Visual Analog Scale (VAS at Baseline
timeFrame: baseline
measure: Nasal Itching as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
timeFrame: 4 weeks post treatment
measure: Nasal Itching as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
timeFrame: 12 weeks post treatment
measure: Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at Baseline
timeFrame: baseline
measure: Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
timeFrame: 4 weeks post treatment
measure: Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
timeFrame: 12 weeks post treatment
measure: Change in Maximum Optical Density Determined Via Optical Rhinometry
timeFrame: baseline, immediately post first treatment on Day 1
measure: Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at Baseline
timeFrame: baseline
measure: Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment
timeFrame: 4 weeks post treatment
measure: Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment
timeFrame: 12 weeks post treatment
measure: Maximum Optical Density Determined Via Optical Rhinometry
timeFrame: 12 weeks post treatment
Secondary outcomes:
measure: Change in Local Immunoglobulin E (IgE) Level
timeFrame: baseline, 12 weeks post treatment
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Kunal R Shetty, MD
role: PRINCIPAL_INVESTIGATOR
References: