Alleviation of Common Cold Symptoms

Sponsor

Applied Biological Laboratories Inc (Other)

Overall Status

Completed

CT.gov ID

NCT06106880

Collaborator

Econometrica, Inc. (Industry)

157

Enrollment

Locations

Arms

12.7

Actual Duration (Months)

26.2

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Common Cold Pharyngitis Fever Congestion Rhinorrhea Cough Sore-throat Sore Throats Viral Malaise Headache Runny Nose Sneezing	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	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

157 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Alleviation of Upper Respiratory Inflammation and Associated Common Cold Symptoms

Actual Study Start Date :

May 25, 2022

Actual Primary Completion Date :

Apr 8, 2023

Actual Study Completion Date :

Jun 16, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Relief of Sore Throat Pain [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 Outcome Measures

Clinical Efficacy Against Common Cold Symptoms [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Telemedicine and Home Visit	Irvine	California	United States	92614-0120
2	Telemedicine and Home Visit	Washington	District of Columbia	United States	20016
3	Telemedicine and Home Visit	Atlanta	Georgia	United States	30002-0082
4	Telemedicine and Home Visit	Baltimore	Maryland	United States	21215
5	Telemedicine and Home Visit	New York	New York	United States	11385
6	Telemedicine and Home Visit	Houston	Texas	United States	77054-3036