NCT06106880

Alleviation of Common Cold Symptoms

Alleviation of Upper Respiratory Inflammation and Associated Common Cold Symptoms

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: Applied Biological Laboratories Inc · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Wintergreen Throat Spray and Aspirin Tablet	The liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin. Aspirin in a 325mg tablet
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.
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.

Timeline

• Start date: 2022-05-25
• Primary completion: 2023-04-08
• Completion: 2023-06-16
• First posted: 2023-10-30
• Last updated: 2024-01-16

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study