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OpenTrials
Completed

NCT Number: NCT06106880

Alleviation of Common Cold Symptoms

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.

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Key information

Conditions

Common Cold Body Temperature Changes Congestion Cough Fever Headache Infections Inflammation Malaise Neurologic Manifestations Otorhinolaryngologic Diseases Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngitis Picornaviridae Infections RNA Virus Infections Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Rhinorrhea Runny Nose Signs and Symptoms Signs and Symptoms, Respiratory Sneezing Sore Throats Viral Sore-throat Stomatognathic Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Telemedicine and Home Visit, Irvine, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wintergreen Throat Spray and Aspirin Tablet

Drug

The liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin.

Aspirin in a 325mg tablet

Other names: Group B

Aspirin Throat Spray and Placebo Tablet

Drug

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.

Other names: Group C

Wintergreen Throat Spray and Placebo Tablet

Dietary 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.

Other names: Group D

Placebo Throat Spray and Placebo Tablet

Other

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.

Other names: Group A

Primary outcomes

  1. Relief of Sore Throat Pain

    Time frame: 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.

Secondary outcomes

  1. Clinical Efficacy Against Common Cold Symptoms

    Time frame: 48 hours

    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.

Sponsors and collaborators

Lead sponsor

Applied Biological Laboratories Inc

Other

Collaborators

  • Econometrica, Inc.

Registry information

Official study title

Alleviation of Upper Respiratory Inflammation and Associated Common Cold Symptoms

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 30, 2023
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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