Intranasal Capsaicin Treatment for Non-Allergic Irritant Rhinitis

NCT02493257 | Completed Phase 2 Results

• 1 other identifier: HSC-MS-14-0173
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonallergic Irritant Rhinitis

Keywords

nonallergic irritant rhinitis; nasal congestion; rhinorrhea

Outcome Measures

Primary Outcomes (4)

• Change in Total Symptom Score

  The Total Symptom Score (TSS) uses a visual analog scale (VAS) to assess typical nasal symptoms of non-allergic rhinitis (NAR), including sneezing, nasal irritation, nasal obstruction, and nasal congestion. The TSS is based on a commonly used rhinitis rating system recommended by the FDA for clinical trial studies on non-allergic rhinitis. 4 symptoms (sneezing, nasal irritation, nasal obstruction, and nasal congestion) are rated on a VAS ranging from 0 (none, no distress) to 10 (agonizing, unbearable distress). The TSS total score is the sum of the VAS score for each of the 4 symptoms, with the TSS total score ranging from 0 (none, no distress) to 40 (agonizing, unbearable distress).

  baseline and 4 weeks

• Change in Total Symptom Score

  The Total Symptom Score (TSS) uses a visual analog scale (VAS) to assess typical nasal symptoms of non-allergic rhinitis (NAR), including sneezing, nasal irritation, nasal obstruction, and nasal congestion. The TSS is based on a commonly used rhinitis rating system recommended by the FDA for clinical trial studies on non-allergic rhinitis. 4 symptoms (sneezing, nasal irritation, nasal obstruction, and nasal congestion) are rated on a VAS ranging from 0 (none, no distress) to 10 (agonizing, unbearable distress). The TSS total score is the sum of the VAS score for each of the 4 symptoms, with the TSS total score ranging from 0 (none, no distress) to 40 (agonizing, unbearable distress).

  baseline and 12 weeks

• Change in Nasal Blood Flow as Indicated by Change in Maximal Optical Density Assessed by Optical Rhinometry

  Optical rhinometry provides continuous measurement of blood flow in nasal vessels (via optical density measurements), which serves as an indirect assessment of nasal congestion. A greater decrease in optical density (OD) from baseline indicates less nasal blood flow and decreased congestion relative to baseline.

  baseline and 4 weeks

• Change in Nasal Blood Flow as Indicated by Change in Maximal Optical Density Assessed by Optical Rhinometry

  Optical rhinometry provides continuous measurement of blood flow in nasal vessels (via optical density measurements), which serves as an indirect assessment of nasal congestion. A greater decrease in optical density (OD) from baseline indicates less nasal blood flow and decreased congestion relative to baseline.

  baseline and 12 weeks

Study Arms (2)

intranasal capsaicin

EXPERIMENTAL

The capsaicin solution will be prepared by using the formula previously reported by Van Rijswijk et al; (0.1mmol/l) diluted in ethanol and 0.9% normal saline (19). Using the mucosal atomizer device (MAD), 0.8 milliliters (mL) will be delivered to each nasal cavity for a total of 24.4 ug per nasal cavity. 5 consecutive applications of capsaicin or placebo will be administered intranasally, with 1 hour between each application.

Drug: Capsaicin

Vehicle solution

PLACEBO COMPARATOR

100 μL of 1% ethanol in 0.9% saline solution. 5 consecutive applications of capsaicin or placebo will be administered intranasally, with 1 hour between each application.

Drug: Placebo

Interventions

Capsaicin DRUG

Also known as: intranasal capsaicin

intranasal capsaicin

Placebo DRUG

Also known as: 1% ethanol in 9% saline

Vehicle solution

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• American Academy of Otolaryngic Allergy: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Nasal Obstruction; Rhinorrhea

Interventions

Capsaicin; Ethanol; Sodium Chloride

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Alcohols; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Small sample size; 2 patients lost to follow-up at 12 weeks; inability to identify NAR patients with elevated local Immunoglobulin E (IgE) levels, which may contribute to limited improvement in some NAR patients in the intervention group.

Results Point of Contact

• Title: Dr. Amber U. Luong, Associate Professor and Director of Research
• Organization: The University of Texas Health Science Center at Houston

Amber.U.Luong@uth.tmc.edu

(713) 500-5410

Study Officials

• Amber U Luong, MD, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: July 9, 2015
• Study Start: October 1, 2014
• Primary Completion: August 2, 2019
• Study Completion: August 2, 2019
• Last Updated: August 17, 2020
• Results First Posted: August 17, 2020

Record last verified: 2020-07

Locations

US (1)