Clinical trial NCT06106880: Alleviation of Common Cold Symptoms
Official title: Alleviation of Upper Respiratory Inflammation and Associated Common Cold Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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
Lead sponsor: Applied Biological Laboratories Inc
Sponsor class: OTHER
Collaborators: name: Econometrica, Inc.
First posted: 2023-10-30
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Relief of Sore Throat Pain
timeFrame: 36 hours
Secondary outcomes:
measure: Clinical Efficacy Against Common Cold Symptoms
timeFrame: 48 hours
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Telemedicine and Home Visit
state: California
city: Washington
country: United States
facility: Telemedicine and Home Visit
state: District of Columbia
city: Atlanta
country: United States
facility: Telemedicine and Home Visit
state: Georgia
city: Baltimore
country: United States
facility: Telemedicine and Home Visit
state: Maryland
city: New York
country: United States
facility: Telemedicine and Home Visit
state: New York
city: Houston
country: United States
facility: Telemedicine and Home Visit
state: Texas
Study officials:
affiliation: Applied Biological Laboratories
name: Nazlie Latefi, PhD
role: STUDY_DIRECTOR
References:
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