About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adults
American Association of Anesthesiology Class 1,"A normal, healthy patient" only
Disqualifiers
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).
Trial design
Single group
Treatments tested in this trial
Capsaicinoid
Other interventionThis is a tolerability study on doses lower than previously published for the use of intranasal capsaicinoid in the treatment of rhinitis
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Sponsors and contacts
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