Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
157 participants
INTERVENTIONAL
2022-05-25
2023-06-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
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
Wintergreen Throat Spray and Aspirin Tablet
The liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin.
Aspirin in a 325mg tablet
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.
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.
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.
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.
Interventions
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Wintergreen Throat Spray and Aspirin Tablet
The liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin.
Aspirin in a 325mg tablet
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.
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.
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 Intervention Names
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Eligibility Criteria
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Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Econometrica, Inc.
INDUSTRY
Applied Biological Laboratories Inc
OTHER
Responsible Party
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Principal Investigators
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Nazlie Latefi, PhD
Role: STUDY_DIRECTOR
Applied Biological Laboratories
Locations
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Telemedicine and Home Visit
Irvine, California, United States
Telemedicine and Home Visit
Washington D.C., District of Columbia, United States
Telemedicine and Home Visit
Atlanta, Georgia, United States
Telemedicine and Home Visit
Baltimore, Maryland, United States
Telemedicine and Home Visit
New York, New York, United States
Telemedicine and Home Visit
Houston, Texas, United States
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Pro 00048530
Identifier Type: -
Identifier Source: org_study_id
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