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Intranasal Capsaicinoid Spray

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ClinicalTrials.gov Identifier: NCT03952845
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
S Mark Taylor, Nova Scotia Health Authority

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.


Condition or disease Intervention/treatment Phase
Tolerance Capsaicin Rhinitis Other: Capsaicinoid Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Tolerability of Intranasal Capsaicinoid Spray
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Arm Intervention/treatment
Experimental: Intranasal Capsaicin
Separate patients will be given escalating doses of intranasal capsaicinoid spray
Other: Capsaicinoid
This is a tolerability study on doses lower than previously published for the use of intranasal capsaicinoid in the treatment of rhinitis




Primary Outcome Measures :
  1. Pain - Visual Analogue Scale (VAS) - Change from 1 hour after pre-treatment baseline [ Time Frame: Pre-treatment and Immediate (1 hour after treatment) ]
    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.

  2. Pain - Visual Analogue Scale (VAS) - Change from 1 week after pre-treatment baseline [ Time Frame: Pre-treatment and Delayed (1 week after treatment) ]
    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.

  3. Rhinorrhea - Likert - Change from 1 hour after pre-treatment baseline [ Time Frame: Pre-treatment and Immediate (1 hour after treatment) ]
    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.

  4. Rhinorrhea - Likert - Change from 1week after pre-treatment baseline [ Time Frame: Pre-treatment and Delayed (1 week after treatment) ]
    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.

  5. Lacrimation - Likert - Change from 1 hour after pre-treatment baseline [ Time Frame: Pre-treatment and Immediate (1 hour after treatment) ]
    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.

  6. Lacrimation - Likert - Change from 1 week after pre-treatment baseline [ Time Frame: Pre-treatment and Delayed (1 week after treatment) ]
    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.

  7. Pain - Likert - Change from 1 hour after pre-treatment baseline [ Time Frame: Pre-treatment and Immediate (1 hour after treatment) ]
    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.

  8. Pain - Likert - Change from 1 week after pre-treatment baseline [ Time Frame: Pre-treatment and Delayed (1 week after treatment) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952845


Contacts
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Contact: David WA Forner, MD 902 473 2222 ext 8247 david.forner@dal.ca
Contact: S Mark Taylor, MD FRCSC 902 473 5752 smarktaylor@eastlink.ca

Locations
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Canada, Nova Scotia
Queen Elizabeth II Health Science Center Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: David W Forner, MD    9027895932    david.forner@dal.ca   
Contact: s M Taylor, MD FRCSC       smarktaylor@eastlink.ca   
Sponsors and Collaborators
Nova Scotia Health Authority
Investigators
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Principal Investigator: S Mark Taylor, MD FRCSC Dalhousie University
Study Director: David WA Forner, MD Dalhousie University

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Responsible Party: S Mark Taylor, Professor - Otolaryngology -- Head & Neck Surgery, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT03952845     History of Changes
Other Study ID Numbers: 1024481
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by S Mark Taylor, Nova Scotia Health Authority:
Capsaicin
Rhinitis

Additional relevant MeSH terms:
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Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs