Phase 2
N=22
Intranasal Capsaicin Treatment for Non-Allergic Irritant Rhinitis
Nonallergic Irritant Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT02493257 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Change in Total Symptom Score — -5; 2 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Capsaicin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Symptom Score |
-4.5; 1.5 | — |
| PRIMARY Change in Total Symptom Score |
-4.5; 1.5 | — |
| PRIMARY Change in Nasal Blood Flow as Indicated by Change in Maximal Optical Density Assessed by Optical Rhinometry |
-0.08; -0.05 | — |
| PRIMARY Change in Nasal Blood Flow as Indicated by Change in Maximal Optical Density Assessed by Optical Rhinometry |
-0.08; -0.05 | — |
Summary
The proposed study seeks to investigate the effect of intranasal capsaicin treatment in patient with Non-allergic irritant rhinitis (NAIR), as well as evaluate optical rhinometry (ORM) as a means to quantify symptomatic improvement in NAIR patients during and after treatment.
Eligibility Criteria
Inclusion criteria
- Non-allergic irritant rhinitis (NAIR) patients as defined by history (symptoms of nasal congestion, rhinorrhea, nasal itching or sneezing upon exposure to nasal irritants)
- Patients with positive optical rhinometer (ORM) response with intranasal challenge with 0.5 millimolar (mM) capsaicin as described by Lambert et al 2012
- Confirmed negative skin prick test to common allergens (which rules out allergic rhinitis)
Exclusion Criteria
- History of sinonasal surgery
- Chronic rhinosinusitis
- Inflammatory or granulomatous diseases
- Asthma
- Allergic rhinitis
- Immunocompromised state
- Radiation to the head and neck
- Intranasal steroid use >4 wks
- Intranasal or systemic antihistamine x 3 days
- Intranasal or systemic decongestants x 3 days
Data sourced from ClinicalTrials.gov (NCT02493257). 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.