Alleviation of Upper Respiratory Inflammation and Associated Common Cold Symptoms
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Relief of Sore Throat Pain
研究概览
简要总结
Upper respiratory infections (URIs) have long posed a significant burden to the US healthcare system. Well before the coronavirus disease of 2019 (COVID-19) pandemic they have been among the most common acute outpatient illnesses, causing 75-100 million physician visits each year on average, and costing the health care system billions of dollars annually. This double-blind randomized placebo-controlled study tested the efficacy of two anti-inflammatory throat sprays against placebo and against a throat spray taken in conjunction with 325mg of aspirin, a well-known systemically administered cyclooxygenase (COX) inhibitor. Participants having common cold symptoms lasting less than two days were enrolled and given treatment to administer at home. Various common cold symptoms were assessed and measured via clinically validated self-assessment scales. Participants were screened for influenza and COVID-19 before enrollment and were excluded if found positive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Otherwise healthy adults with cold symptoms including sore throat who do not meet any of the exclusion criteria listed below,
- •who rate their sore throat at least a 3 on a 10-point scale,
- •who have had a sore throat for less than 48 hours by the time they complete the intake clinical trial manager (CTM) assessment.
排除标准
- •Sore throat for more than 2 full days at the time of intake CTM assessment
- •Fever or development of fever during the course of the trial
- •Positive COVID-19 test or influenza test at clinical trial administrator (CTA) visit
- •Likelihood of strep throat (to be determined by physician PI to the best of their ability)
- •Less than 2 doses of the coronavirus (COVID-19) vaccine
- •Any allergies to eggs, milk, or aspirin
- •Females who are pregnant or test positive for pregnancy at the CTA visit
- •Any chronic disease such as asthma, hypertension, post-nasal drip, gastroesophageal reflux disease (GERD), cardiopulmonary obstructive disorder (COPD), diabetes, cancer, HIV
- •Any history of allergy in the last 14 days for which they took medication
- •Anyone with fever above 101 or who has taken medication other than birth control in the last 30 days
- •Anyone taking an Angiotensin Converting Enzyme (ACE) inhibitor
- •Participation in another clinical trial within the last 6 months or during this trial
- •Anyone who smokes
研究组 & 干预措施
Group A: Placebo Throat Spray and Placebo Tablet
The placebo spray contained vehicle buffer, a sub-therapeutic dose of menthol, and a sweetener.
Placebo Tablet: Looked like the treatment aspirin tablet but contained no drug and only inactive excipients.
干预措施: Placebo Throat Spray and Placebo Tablet (Other)
Group B: Wintergreen Throat Spray and Aspirin Tablet
The liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin.
Aspirin in a 325mg tablet
干预措施: Wintergreen Throat Spray and Aspirin Tablet (Drug)
Group C: Aspirin Throat Spray and Placebo Tablet
The liquid spray contained 6mg dissolved acetyl salicylic acid per dose, menthol, lactoferrin, lysozyme, aloe, and glycerin.
Placebo Tablet: Looked like the treatment aspirin tablet but contained no drug and only inactive excipients.
干预措施: Aspirin Throat Spray and Placebo Tablet (Drug)
Group D: Wintergreen Throat Spray and Placebo Tablet
The liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin.
Placebo Tablet: Looked like the treatment aspirin tablet but contained no drug and only inactive excipients.
干预措施: Wintergreen Throat Spray and Placebo Tablet (Dietary Supplement)
结局指标
主要结局
Relief of Sore Throat Pain
时间窗: 36 hours
A time-weighted summed difference in pain intensity on the sore throat pain intensity scale (STPIS) after the first dose of medication (STPIS 1st entry Day 1 compared to STPIS 4th entry Day 2). On the STPIS, 0mm, the leftmost point of the line, represents no throat pain, and 100mm, the rightmost point of the line, represents the most severe throat pain.
次要结局
- Clinical Efficacy Against Common Cold Symptoms(48 hours)