Alleviation of Common Cold Symptoms

Headache Clinical Trial

Official title:

Alleviation of Upper Respiratory Inflammation and Associated Common Cold Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06106880
• Other study ID #: Pro 00048530
• Status: Completed
• Phase: Phase 1
• Start date: May 25, 2022
• Est. completion date: June 16, 2023

Study information

• Verified date: January 2024
• Source: Applied Biological Laboratories Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: June 16, 2023
• Est. primary completion date: April 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Common Cold
• Congestion
• Cough
• Fever
• Headache
• Pharyngitis
• Rhinorrhea
• Sneezing

Intervention

Drug:
• 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.

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:
• 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.

Locations

Country	Name	City	State
United States	Telemedicine and Home Visit	Atlanta	Georgia
United States	Telemedicine and Home Visit	Baltimore	Maryland
United States	Telemedicine and Home Visit	Houston	Texas
United States	Telemedicine and Home Visit	Irvine	California
United States	Telemedicine and Home Visit	New York	New York
United States	Telemedicine and Home Visit	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Applied Biological Laboratories Inc	Econometrica, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical Efficacy Against Common Cold Symptoms	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