Alleviation of Common Cold Symptoms

NCT06106880 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: Pro 00048530
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 6

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Relief of Sore Throat Pain

  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 Outcomes (1)

• Clinical Efficacy Against Common Cold Symptoms

  48 hours

Study Arms (4)

Group A: Placebo Throat Spray and Placebo Tablet

PLACEBO COMPARATOR

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

Group B: Wintergreen Throat Spray and Aspirin Tablet

ACTIVE COMPARATOR

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

Drug: Wintergreen Throat Spray and Aspirin Tablet

Group C: Aspirin Throat Spray and Placebo Tablet

ACTIVE COMPARATOR

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

Group D: Wintergreen Throat Spray and Placebo Tablet

ACTIVE COMPARATOR

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

Interventions

Wintergreen Throat Spray and Aspirin Tablet DRUG

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

Also known as: Group B

Group B: Wintergreen Throat Spray and Aspirin Tablet

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.

Also known as: Group C

Group C: Aspirin Throat Spray and Placebo Tablet

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.

Also known as: Group D

Group D: Wintergreen Throat Spray and Placebo Tablet

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.

Also known as: Group A

Group A: Placebo Throat Spray and Placebo Tablet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Applied Biological Laboratories Inc: lead
• Econometrica, Inc.: collaborator

Study Sites (6)

Telemedicine and Home Visit

Irvine, California, 92614-0120, United States

Location

Telemedicine and Home Visit

Washington D.C., District of Columbia, 20016, United States

Location

Telemedicine and Home Visit

Atlanta, Georgia, 30002-0082, United States

Location

Telemedicine and Home Visit

Baltimore, Maryland, 21215, United States

Location

Telemedicine and Home Visit

New York, New York, 11385, United States

Location

Telemedicine and Home Visit

Houston, Texas, 77054-3036, United States

Location

Related Publications (12)

• 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.

  PMID: 23091044 BACKGROUND

• 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.

  PMID: 26387658 BACKGROUND

• 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.

  PMID: 3018306 BACKGROUND

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

  PMID: 8073865 BACKGROUND

• 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.

  PMID: 3345041 BACKGROUND

• 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.

  PMID: 2262647 BACKGROUND

• 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.

  PMID: 23533982 BACKGROUND

• 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.

  PMID: 24988909 BACKGROUND

• 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.

  PMID: 27542891 BACKGROUND

• 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.

  PMID: 12873261 BACKGROUND

• 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.

  PMID: 34153179 BACKGROUND

• Pugach P, Sadeghi-Latefi N. Supporting respiratory epithelia and lowering inflammation to effectively treat common cold symptoms: A randomized controlled trial. PLoS One. 2024 Nov 27;19(11):e0301959. doi: 10.1371/journal.pone.0301959. eCollection 2024.

  PMID: 39602479 DERIVED

MeSH Terms

Conditions

Common Cold; Pharyngitis; Fever; Rhinorrhea; Cough; Headache; Sneezing; Inflammation

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Respiration Disorders; Pain; Neurologic Manifestations; Pathologic Processes

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Nazlie Latefi, PhD

  Applied Biological Laboratories

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 30, 2023
• Study Start: May 25, 2022
• Primary Completion: April 8, 2023
• Study Completion: June 16, 2023
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (6)