Alleviation of Common Cold Symptoms

Applied Biological Laboratories Inc

Status and phase: Completed; Phase 1

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

Treatments: Dietary Supplement: Wintergreen Throat Spray and Placebo Tablet; Drug: Aspirin Throat Spray and Placebo Tablet; Drug: Wintergreen Throat Spray and Aspirin Tablet; Other: Placebo Throat Spray and Placebo Tablet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06106880

Pro 00048530

Details and patient eligibility

About

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.

Enrollment: 157 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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157 participants in 4 patient groups, including a placebo group

Group A: Placebo Throat Spray and Placebo Tablet

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo Throat Spray and Placebo Tablet

Group B: Wintergreen Throat Spray and Aspirin Tablet

Active Comparator group

Description:

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

Treatment:

Drug: Wintergreen Throat Spray and Aspirin Tablet

Group C: Aspirin Throat Spray and Placebo Tablet

Active Comparator group

Description:

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.

Treatment:

Drug: Aspirin Throat Spray and Placebo Tablet

Group D: Wintergreen Throat Spray and Placebo Tablet

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Wintergreen Throat Spray and Placebo Tablet