Alleviation of Common Cold Symptoms

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ClinicalTrials.gov Identifier: NCT06106880

Recruitment Status : Completed

First Posted : October 30, 2023

Last Update Posted : January 16, 2024

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborator:

Econometrica, Inc.

Information provided by (Responsible Party):

Applied Biological Laboratories Inc

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

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Study Type :	Interventional (Clinical Trial)
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 :	April 8, 2023
Actual Study Completion Date :	June 16, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Common Cold

Drug Information available for: Aspirin

U.S. FDA Resources

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 Name: 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 Name: 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 Name: 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 Name: Group D

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06106880

Locations

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

Sponsors and Collaborators

Applied Biological Laboratories Inc

Econometrica, Inc.

Investigators

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Study Director:	Nazlie Latefi, PhD	Applied Biological Laboratories

Study Documents (Full-Text)

Documents provided by Applied Biological Laboratories Inc:

Study Protocol and Statistical Analysis Plan [PDF] May 2, 2022

More Information

Publications:

Shulman ST, Bisno AL, Clegg HW, Gerber MA, Kaplan EL, Lee G, Martin JM, Van Beneden C. Clinical practice guideline for the diagnosis and management of group A streptococcal pharyngitis: 2012 update by the Infectious Diseases Society of America. Clin Infect Dis. 2012 Nov 15;55(10):1279-82. doi: 10.1093/cid/cis847. Erratum In: Clin Infect Dis. 2014 May;58(10):1496. Dosage error in article text.

Kim SY, Chang YJ, Cho HM, Hwang YW, Moon YS. Non-steroidal anti-inflammatory drugs for the common cold. Cochrane Database Syst Rev. 2015 Sep 21;2015(9):CD006362. doi: 10.1002/14651858.CD006362.pub4.

Winther B, Gwaltney JM Jr, Mygind N, Turner RB, Hendley JO. Sites of rhinovirus recovery after point inoculation of the upper airway. JAMA. 1986 Oct 3;256(13):1763-7.

Rees GL, Eccles R. Sore throat following nasal and oropharyngeal bradykinin challenge. Acta Otolaryngol. 1994 May;114(3):311-4. doi: 10.3109/00016489409126062.

Proud D, Reynolds CJ, Lacapra S, Kagey-Sobotka A, Lichtenstein LM, Naclerio RM. Nasal provocation with bradykinin induces symptoms of rhinitis and a sore throat. Am Rev Respir Dis. 1988 Mar;137(3):613-6. doi: 10.1164/ajrccm/137.3.613.

Doyle WJ, Boehm S, Skoner DP. Physiologic responses to intranasal dose-response challenges with histamine, methacholine, bradykinin, and prostaglandin in adult volunteers with and without nasal allergy. J Allergy Clin Immunol. 1990 Dec;86(6 Pt 1):924-35. doi: 10.1016/s0091-6749(05)80156-3.

Gupta U, Verma M. Placebo in clinical trials. Perspect Clin Res. 2013 Jan;4(1):49-52. doi: 10.4103/2229-3485.106383. No abstract available.

Schachtel B, Aspley S, Shephard A, Shea T, Smith G, Schachtel E. Utility of the sore throat pain model in a multiple-dose assessment of the acute analgesic flurbiprofen: a randomized controlled study. Trials. 2014 Jul 3;15:263. doi: 10.1186/1745-6215-15-263.

Glatthaar-Saalmuller B, Mair KH, Saalmuller A. Antiviral activity of aspirin against RNA viruses of the respiratory tract-an in vitro study. Influenza Other Respir Viruses. 2017 Jan;11(1):85-92. doi: 10.1111/irv.12421. Epub 2016 Sep 22.

Eccles R, Loose I, Jawad M, Nyman L. Effects of acetylsalicylic acid on sore throat pain and other pain symptoms associated with acute upper respiratory tract infection. Pain Med. 2003 Jun;4(2):118-24. doi: 10.1046/j.1526-4637.2003.03019.x.

Leyva-Grado V, Pugach P, Sadeghi-Latefi N. A novel anti-inflammatory treatment for bradykinin-induced sore throat or pharyngitis. Immun Inflamm Dis. 2021 Dec;9(4):1321-1335. doi: 10.1002/iid3.479. Epub 2021 Jun 21.

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Responsible Party:	Applied Biological Laboratories Inc
ClinicalTrials.gov Identifier:	NCT06106880
Other Study ID Numbers:	Pro 00048530
First Posted:	October 30, 2023 Key Record Dates
Last Update Posted:	January 16, 2024
Last Verified:	January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Will be determined as needed, if shared no identifiable personal information will be provided.
Supporting Materials:	Study Protocol Statistical Analysis Plan (SAP)
Time Frame:	Will be determined as needed
Access Criteria:	Requesting researchers will only receive the participant's code number, age, sex, ethnicity, but no other identifying information.

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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

Keywords provided by Applied Biological Laboratories Inc:


Common Cold Pharyngitis Fever Congestion Rhinorrhea Cough	Sore Throat Malaise Headache Runny Nose Sneezing Inflammation

Additional relevant MeSH terms:

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Pharyngitis Common Cold Headache Rhinorrhea Sneezing Pain Neurologic Manifestations Respiratory Tract Diseases Signs and Symptoms, Respiratory Respiratory Tract Infections Infections Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Picornaviridae Infections	RNA Virus Infections Virus Diseases Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors

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