Intranasal Capsaicinoid Spray
Intranasal Capsaicinoid Spray
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.
Inflammation of the nasal mucosa (internal lining of the nose) results in a condition called
 rhinitis. Patients with rhinitis suffer from nasal stuffiness, congestion, rhinorrhea (nasal
 discharge), sneezing, and itchiness. Rhinitis affects a large number of people, with several
 studies estimating that between 10 and 50% of people have rhinitis.

 The term rhinitis includes many different diseases that are commonly divided into allergic
 rhinitis and non-allergic rhinitis. Allergic rhinitis is a result of allergen exposure, with
 the diagnosis requiring an identifiable offending agent. Common allergens include pollen,
 molds, animals, and insects. Allergic rhinitis has similar symptoms to those outlined above
 and can be confirmed by allergy skin testing. There is also a strong association between
 allergic rhinitis and asthma, with one third of allergic rhinitis patients also suffering
 from reactive airway disease.

 On the other hand, non-allergic rhinitis is a broad category and includes all forms of
 rhinitis that do not have an identifiable allergic component. Subcategories of non-allergic
 rhinitis include occupational, gustatory, smoking, hormonal, senile, atrophic,
 medication-induced, vasomotor (idiopathic), local allergic, and non-allergic rhinitis with
 eosinophilia syndrome (NARES).

 Avoidance of triggers and use of intranasal medication, such as intranasal steroids and
 intranasal antihistamines, are the mainstays of treatment for non-allergic rhinitis.
 Combination of intranasal steroid and antihistamine has recently been developed as a single
 product and approved for the use in both allergic and non-allergic rhinitis. When high
 volume, clear rhinorrhea is the primary rhinitis symptom, intranasal anticholinergics have
 shown good effect. Finally, surgical intervention is considered in patients with select
 non-allergic rhinitis causes, such as vasomotor rhinitis.

 The use of intranasal capsaiscinoid spray for treatment of rhinitis has been investigated for
 many years. The first identifiable trial was in 1991 and showed that both subjective and
 objective measurements of chronic rhinitis were reduced with repeated applications of
 intranasal capsaicin.

 Capsaicinoids are active ingredients in the plant genus Capsicum, which includes bell
 peppers, habanero peppers, and jalapeno peppers, amongst others. The most noteworthy of the
 capsaicinoids is capsaicin. All capsaicinoids are irritants for humans, and they give the
 Capsicum plants their pungent taste and hot sensation, as well as produce the burning
 sensation from topical application.

 Capsaicinoids are believed to be effective for non-allergic rhinitis due to their ability to
 block specific nerve fibers in the lining of the nose. Blocking this pathway results in
 decreased nasal hypersensitivity and leads to reduced nasal obstruction, sneezing, and
 rhinorrhea.

 More recently, a systematic review for the Cochrane Collaboration was carried out. Four
 studies were included in the review, representing 302 patients. The authors of the review
 conclude that given many therapeutic options for non-allergic rhinitis are ineffective, the
 use of intranasal capsaicinoid as possible treatment modality is reasonable.

 It should be noted that each of the four studies included in the review utilized a different
 dose of capsaiscinoid, and indeed a different capsaiscinoid altogether.

 Despite many trials documenting the efficacy of intranasal capsaicinoids for non-allergic
 rhinitis, tolerability of the intervention is poorly studied. Also of note is that many of
 the current studies utilizing intranasal capsaicinoids have used some form of topical
 anesthetic in order to deliver high doses.

 Therefore, given that intranasal capsaicinoid spray is an enticing treatment option for
 non-allergic rhinitis in terms of efficacy, and there is a dearth of reliable tolerability
 studies, we would seek to identify the side effect profile of a naturally sourced intranasal
 capsaicin spray. As pelargonic acid vanillylamide (PAVA) is the most studied capsaicinoid in
 terms of efficacy in humans, we propose to utilize this for our study.

 The proposed study would address the following objectives:

 1. Determine the rate and severity of intranasal burning sensation and pain with
 administration of intranasal PAVA in an otherwise healthy population with no history of
 medical or surgical nasal disease

 a. Measured using both a Likert scale and a Visual Analogue Scale (VAS)

 2. Determine the rate and severity of lacrimation with administration of intranasal PAVA in
 an otherwise healthy population with no history of medical or surgical nasal disease

 a. Measured using a Likert scale

 3. Determine the rate and severity of rhinorrhea with administration of intranasal PAVA in
 an otherwise healthy population with no history of medical or surgical nasal disease

 a. Measured using a Likert scale

 4. Determine the overall patient perceived tolerability of intranasal PAVA administration
 in an otherwise healthy population with no history of medical or surgical nasal disease
 a. Considered an overall combined measure of all Likert scales and VAS
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).