Alleviation of Common Cold Symptoms

January 12, 2024 updated by: Applied Biological Laboratories Inc

Alleviation of Upper Respiratory Inflammation and Associated 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

157

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92614-0120
        • Telemedicine and Home Visit
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Telemedicine and Home Visit
    • Georgia
      • Atlanta, Georgia, United States, 30002-0082
        • Telemedicine and Home Visit
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Telemedicine and Home Visit
    • New York
      • New York, New York, United States, 11385
        • Telemedicine and Home Visit
    • Texas
      • Houston, Texas, United States, 77054-3036
        • Telemedicine and Home Visit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Other: Placebo Throat Spray and Placebo Tablet

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
Active Comparator: 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
Drug: Wintergreen Throat Spray and Aspirin Tablet

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

Aspirin in a 325mg tablet

Other Names:
  • Group B
Active Comparator: 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.
Drug: 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.

Other Names:
  • Group C
Active Comparator: 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.
Dietary supplement: Wintergreen Throat Spray and Placebo Tablet

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
36 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Applied Biological Laboratories Inc

Collaborators

Econometrica, Inc.

Investigators

  • Study Director: Nazlie Latefi, PhD, Applied Biological Laboratories

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2022

Primary Completion (Actual)

April 8, 2023

Study Completion (Actual)

June 16, 2023

Study Registration Dates

First Submitted

October 18, 2023

First Submitted That Met QC Criteria

October 24, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Estimated)

January 15, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro 00048530

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Will be determined as needed, if shared no identifiable personal information will be provided.

IPD Sharing Time Frame

Will be determined as needed

IPD Sharing Access Criteria

Requesting researchers will only receive the participant's code number, age, sex, ethnicity, but no other identifying information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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