Tolerability of Intranasal Capsaicinoid Spray
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pain - Visual Analogue Scale (VAS) - Change from 1 week after pre-treatment baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults
- •American Association of Anesthesiology Class 1,"A normal, healthy patient" only
排除标准
- •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).
结局指标
主要结局
Pain - Visual Analogue Scale (VAS) - Change from 1 week after pre-treatment baseline
时间窗: 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.
Rhinorrhea - Likert - Change from 1 hour after pre-treatment baseline
时间窗: 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.
Rhinorrhea - Likert - Change from 1week after pre-treatment baseline
时间窗: 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.
Lacrimation - Likert - Change from 1 week after pre-treatment baseline
时间窗: 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.
Lacrimation - Likert - Change from 1 hour after pre-treatment baseline
时间窗: 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.
Pain - Visual Analogue Scale (VAS) - Change from 1 hour after pre-treatment baseline
时间窗: 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.
Pain - Likert - Change from 1 week after pre-treatment baseline
时间窗: 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.
Pain - Likert - Change from 1 hour after pre-treatment baseline
时间窗: 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.
次要结局
未报告次要终点