Intranasal Capsaicinoid Spray

NCT03952845 | Not Yet Recruiting

• 1 other identifier: 1024481
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Rhinitis is inflammation of the inside of the nose. Symptoms of rhinitis include itchiness, sneezing, and a "runny" nose (rhinorrhea). There are many different causes for rhinitis, including allergies, age, different irritants in the air, overacting nervous system, and others. Many current treatments for rhinitis are not helpful or are unable to be used for long periods of time. Capsaicin ("Kap-Sey-Uh-Sin") is a natural product that is found in many spicy foods, including hot peppers. This natural product has been used as a lotion to prevent pain, and scientists have found that it may reduce the symptoms of rhinitis when used as a spray in the nose. However, capsaicin is known to cause a burning sensation. This study is needed so we can figure out what doses of capsaicin cause this burning sensation, and to what level these doses cause discomfort. Capsaicin can also cause a small degree of tearing from the eyes when used as a spray in the nose, and can also cause the nose to become "runny" (rhinorrhea). When the safest dose of capsaicin spray is found, that dose can be used to treat people with rhinitis that is not getting better from standard treatments.

Conditions

Tolerance; Capsaicin; Rhinitis

Keywords

Capsaicin; Rhinitis

Outcome Measures

Primary Outcomes (8)

• Pain - Visual Analogue Scale (VAS) - Change from 1 hour after pre-treatment baseline

  Visual analogue scale will be used to analyze participant's perception of pain with the use of intranasal capsaicinoid spray. The visual analogue scale will be presented as a single line scale that is 100mm (0mm to 100mm) in length that the patient my place a mark on to indicate the severity of their pain. The distance (mm) of this mark from the 0 set point will determine the severity score.

  Pre-treatment and Immediate (1 hour after treatment)

• Pain - Visual Analogue Scale (VAS) - Change from 1 week after pre-treatment baseline

  Visual analogue scale will be used to analyze participant's perception of pain with the use of intranasal capsaicinoid spray. The visual analogue scale will be presented as a single line scale that is 100mm (0mm to 100mm) in length that the patient my place a mark on to indicate the severity of their pain. The distance (mm) of this mark from the 0 set point will determine the severity score.

  Pre-treatment and Delayed (1 week after treatment)

• Rhinorrhea - Likert - Change from 1 hour after pre-treatment baseline

  Likert scale will be used to analyze participant's perception of rhinorrhea ("runny-nose") with the use of intranasal capsaicinoid spray. Likert scale choices include: None (0), Very minimal (1), Mild (2), Moderate (3), Severe (4), and Very severe (5). Only a single option may be chosen, and this will be used to determine the severity score.

  Pre-treatment and Immediate (1 hour after treatment)

• Rhinorrhea - Likert - Change from 1week after pre-treatment baseline

  Likert scale will be used to analyze participant's perception of rhinorrhea ("runny-nose") with the use of intranasal capsaicinoid spray. Likert scale choices include: None (0), Very minimal (1), Mild (2), Moderate (3), Severe (4), and Very severe (5). Only a single option may be chosen, and this will be used to determine the severity score.

  Pre-treatment and Delayed (1 week after treatment)

• Lacrimation - Likert - Change from 1 hour after pre-treatment baseline

  Likert scale will be used to analyze participant's perception of lacrimation ("teary-eyes") with the use of intranasal capsaicinoid spray. Likert scale choices include: None (0), Very minimal (1), Mild (2), Moderate (3), Severe (4), and Very severe (5). Only a single option may be chosen, and this will be used to determine the severity score.

  Pre-treatment and Immediate (1 hour after treatment)

• Lacrimation - Likert - Change from 1 week after pre-treatment baseline

  Likert scale will be used to analyze participant's perception of lacrimation ("teary-eyes") with the use of intranasal capsaicinoid spray. Likert scale choices include: None (0), Very minimal (1), Mild (2), Moderate (3), Severe (4), and Very severe (5). Only a single option may be chosen, and this will be used to determine the severity score.

  Pre-treatment and Delayed (1 week after treatment)

• Pain - Likert - Change from 1 hour after pre-treatment baseline

  Likert scale will be used to analyze participant's perception of pain with the use of intranasal capsaicinoid spray. Likert scale choices include: None (0), Very minimal (1), Mild (2), Moderate (3), Severe (4), and Very severe (5). Only a single option may be chosen, and this will be used to determine the severity score.

  Pre-treatment and Immediate (1 hour after treatment)

• Pain - Likert - Change from 1 week after pre-treatment baseline

  Likert scale will be used to analyze participant's perception of pain with the use of intranasal capsaicinoid spray. Likert scale choices include: None (0), Very minimal (1), Mild (2), Moderate (3), Severe (4), and Very severe (5). Only a single option may be chosen, and this will be used to determine the severity score.

  Pre-treatment and Delayed (1 week after treatment)

Study Arms (1)

Intranasal Capsaicin

EXPERIMENTAL

Separate patients will be given escalating doses of intranasal capsaicinoid spray

Other: Capsaicinoid

Interventions

Capsaicinoid OTHER

This is a tolerability study on doses lower than previously published for the use of intranasal capsaicinoid in the treatment of rhinitis

Intranasal Capsaicin

Eligibility Criteria

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

You may qualify if:

• Healthy adults
• American Association of Anesthesiology Class 1,"A normal, healthy patient" only

You may not qualify if:

• Age less than 18 years
• Pregnancy
• Previous nasal or paranasal sinus surgery or radiation
• Allergies to capsaicinoids or capsaicinoid containing products (any combination of sweet peppers, or hot peppers).

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Queen Elizabeth II Health Science Center

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

MeSH Terms

Conditions

Rhinitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• S Mark Taylor, MD FRCSC

  Dalhousie University

  PRINCIPAL INVESTIGATOR

• David WA Forner, MD

  Dalhousie University

  STUDY DIRECTOR

Central Study Contacts

David WA Forner, MD

CONTACT

902 473 2222; david.forner@dal.ca

S Mark Taylor, MD FRCSC

CONTACT

902 473 5752; smarktaylor@eastlink.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In brief, three consecutive patients will receive the initial intervention dose, and complete a post-intervention assessment. Subsequent cohorts receive escalating doses that are determined in advance (see below). If no patients in the initial cohort experience a dose limiting toxicity, three new patients will be recruited into the subsequent cohort and each will receive the escalated dose. This process continues on until at least one patient in a cohort experiences a dose limiting toxicity. When this occurs, three new patients will be recruited but will receive the same dose as the patient who experienced a dose limiting toxicity. If no patients in this new cohort experience a dose limiting toxicity, three additional patients will be recruited and will receive the next predetermined escalated dose. However, if two of six patients experience a dose limiting toxicity, the trial is considered complete and the dose these six patients received is considered the maximum tolerated dose.

Study Record Dates

• First Submitted: May 11, 2019
• First Posted: May 16, 2019
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)