Phase 3
Completed N=28
The Prevalence of Local Immunoglobulin E (IgE) Elevation and Its Effect on Intranasal Capsaicin Therapy in the Non-allergic Rhinitis Population
Non-allergic Rhinitis
Source: ClinicalTrials.gov NCT05093478 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: Runny Nose as Measured by the Visual Analog Scale (VAS) at Baseline — 6.07 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Runny Nose as Measured by the Visual Analog Scale (VAS) at Baseline |
6.07 | — |
| PRIMARY Runny Nose as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment |
2.89 | — |
| PRIMARY Runny Nose as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment |
3.75 | — |
| PRIMARY Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at Baseline |
5.57 | — |
| PRIMARY Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment |
2.46 | — |
| PRIMARY Nasal Symptoms of Congestion as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment |
2.75 | — |
| PRIMARY Nasal Itching as Measured by the Visual Analog Scale (VAS at Baseline |
2.25 | — |
| PRIMARY Nasal Itching as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment |
1.50 | — |
| PRIMARY Nasal Itching as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment |
1.20 | — |
| PRIMARY Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at Baseline |
3.03 | — |
| PRIMARY Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment |
1.71 | — |
| PRIMARY Nasal Sneezing as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment |
2.29 | — |
| PRIMARY Change in Maximum Optical Density Determined Via Optical Rhinometry |
0.36 | — |
| PRIMARY Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at Baseline |
16.92 | — |
| PRIMARY Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at 4 Weeks Post Treatment |
8.57 | — |
| PRIMARY Total Nasal Symptom Score as Measured by the Visual Analog Scale (VAS) at 12 Weeks Post Treatment |
10 | — |
| PRIMARY Maximum Optical Density Determined Via Optical Rhinometry |
— | — |
| SECONDARY Change in Local Immunoglobulin E (IgE) Level |
0.17 | — |
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
Data sourced from ClinicalTrials.gov (NCT05093478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.