Intranasal Capsaicin Treatment for Non-Allergic Irritant Rhinitis
Information source: The University of Texas Health Science Center, Houston
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nonallergic Irritant Rhinitis
Intervention: Capsaicin (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: The University of Texas Health Science Center, Houston Official(s) and/or principal investigator(s): Chauchau T Pham, MD, MS, Principal Investigator, Affiliation: The University of Texas Health Science Center, Houston
Overall contact: Chauchau T Pham, MD, MS, Email: chauchau.t.pham@uth.tmc.edu
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.
Clinical Details
Official title: Double-Blinded Randomized Prospective Trial of Intranasal Capsaicin Treatment for Non-Allergic Irritant Rhinitis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in Composite Symptom Scores at 4 weeksChange in Composite Symptom Scores at 12 weeks Change at 4 weeks in maximum optical density with intranasal capsaicin challenge Change at 12 weeks in maximum optical density with intranasal capsaicin challenge
Detailed description:
A study by Lambert et. al. (2012) was able to objectively identify patients with NAIR by
intranasal capsaicin challenge followed by assessment with optical rhinometry. Studies have
shown that capsaicin therapy can improve symptoms of patients historically identified with
NAIR via visual analog scale (VAS) rating of symptoms and symptom surveys; however, there
has been no study evaluating the capsaicin therapy on patients objectively identified as
NAIR patients.
Multiple studies have demonstrated that intranasal capsaicin can improve nasal symptoms of
NAIR patients. Regarding the usage of capsaicin, there is a product on the market: Sinus
Buster which has capsaicin as the active ingredient. Numerous research papers have evaluated
the efficacy and safety of Sinus Buster for the treatment of congestion in non-allergic
rhinitis patients. However, the diagnosis of NAIR in these previous studies was based
primarily on history. In addition, the primary outcome in these studies was symptomatic
without any objective evaluation. The goal of this study will be two-fold: with patients
objectively identified as NAIR patients via the optical rhinometer, we will re-evaluate the
therapeutic action of intranasal capsaicin on the management of rhinitic symptoms. We expect
that the patients will show significant improvement in their symptoms. We will then use
optical rhinometry as a means to objectively monitor changes in symptoms in NAIR patients.
We expect that post treatment, patients will no longer have the positive response previously
seen on intranasal capsaicin challenge before receiving treatment. We hope to be able to
establish optical rhinometry as an objective measurement of symptom improvement for NAIR
symptoms, along with the subjective patient surveys.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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 mM capsaicin as described by Lambert et al 2012
- Between 18-65 years of age
- 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
Locations and Contacts
Chauchau T Pham, MD, MS, Email: chauchau.t.pham@uth.tmc.edu
The University of Texas Health Science Center at Houston, Houston, Texas 77030, United States; Recruiting Chauchau T Pham, MD, MS, Email: chauchau.t.pham@uth.tmc.edu Chauchau T Pham, MD, MS, Principal Investigator
Additional Information
Starting date: October 2014
Last updated: July 6, 2015
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