Alleviation of Common Cold Symptoms

Applied Biological Laboratories Inc157 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

157

Conditions

Common Cold Pharyngitis Fever

Interventions

Wintergreen Throat Spray and Aspirin TabletDRUG

The liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin. Aspirin in a 325mg tablet

Aspirin Throat Spray and Placebo TabletDRUG

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.

Wintergreen Throat Spray and Placebo TabletDIETARY_SUPPLEMENT

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.

Placebo Throat Spray and Placebo TabletOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (6)

Telemedicine and Home Visit

Irvine, California, United States

Telemedicine and Home Visit

Washington D.C., District of Columbia, United States

Telemedicine and Home Visit

Atlanta, Georgia, United States

Telemedicine and Home Visit

Baltimore, Maryland, United States

Telemedicine and Home Visit

New York, New York, United States

Telemedicine and Home Visit

Houston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 36 hours

Secondary Outcomes

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.

Time frame: 48 hours