Clinical trial NCT02493257: Intranasal Capsaicin Treatment for Non-Allergic Irritant Rhinitis
Official title: Double-Blinded Randomized Prospective Trial of Intranasal Capsaicin Treatment for Non-Allergic Irritant Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nonallergic Irritant Rhinitis
Keywords: nonallergic irritant rhinitis
nasal congestion
rhinorrhea
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: American Academy of Otolaryngic Allergy
First posted: 2015-07-09
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Change in Total Symptom Score
timeFrame: baseline and 4 weeks
measure: Change in Total Symptom Score
timeFrame: baseline and 12 weeks
measure: Change in Nasal Blood Flow as Indicated by Change in Maximal Optical Density Assessed by Optical Rhinometry
timeFrame: baseline and 4 weeks
measure: Change in Nasal Blood Flow as Indicated by Change in Maximal Optical Density Assessed by Optical Rhinometry
timeFrame: baseline and 12 weeks
Secondary outcomes:
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: Amber U Luong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: