Alleviation of Common Cold Symptoms

Study Overview
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Brief Summary
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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.

Official Title
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Alleviation of Upper Respiratory Inflammation and Associated Common Cold Symptoms

Conditions
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Common Cold, Pharyngitis, Fever, Congestion, Rhinorrhea, Cough, Sore-throat, Sore Throats Viral, Malaise, Headache, Runny Nose, Sneezing

Intervention / Treatment
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* Drug: Wintergreen Throat Spray and Aspirin Tablet
* Drug: Aspirin Throat Spray and Placebo Tablet
* Dietary Supplement: Wintergreen Throat Spray and Placebo Tablet
* Other: Placebo Throat Spray and Placebo Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group A: Placebo Throat Spray and Placebo Tablet<br>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. | Other: Placebo Throat Spray and Placebo Tablet<br>* The placebo spray contained vehicle buffer, a sub-therapeutic dose of menthol, and a sweetener. The placebo tablet looked like the treatment aspirin tablet but contained no drug and only inactive excipients.<br>* Other names: Group A;|
| Active Comparator: Group B: Wintergreen Throat Spray and Aspirin Tablet<br>The liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin. Aspirin in a 325mg tablet | Drug: Wintergreen Throat Spray and Aspirin Tablet<br>* The liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin. Aspirin in a 325mg tablet<br>* Other names: Group B;|
| Active Comparator: Group C: Aspirin Throat Spray and Placebo Tablet<br>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. | Drug: Aspirin Throat Spray and Placebo Tablet<br>* 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.<br>* Other names: Group C;|
| Active Comparator: Group D: Wintergreen Throat Spray and Placebo Tablet<br>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. | Dietary Supplement: Wintergreen Throat Spray and Placebo Tablet<br>* The liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin. The placebo tablet looked like the treatment aspirin tablet but contained no drug and only inactive excipients.<br>* Other names: Group D;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief of Sore Throat Pain | 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. | 36 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Efficacy Against Common Cold Symptoms | Secondary endpoints will include changes to the Modified Jackson Score, measured from Absent=0, Mild=1, Moderate=2 to Severe=3, with a higher score representing worsening of various cold symptoms and a lower score signifying improvement of various cold symptoms. | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Common Cold, Pharyngitis, Fever, Congestion, Rhinorrhea, Cough, Sore Throat, Malaise, Headache, Runny Nose, Sneezing, Inflammation