Efficacy Trial of 3804-250A in the Prevention of Cold Illnesses

Phase 2

Completed

• Conditions: Common Cold
• Interventions: Drug: 3804-291; Drug: 3804-250A

• Registration Number: NCT00762476
• Lead Sponsor: The Dial Corporation

Brief Summary

The purpose of this study is to evaluate the efficacy of 3804-250A in the prevention of the common cold. The study will also evaluate whether 3804-250A prevents rhinovirus infection, a virus that causes many common colds.

Detailed Description

Rhinovirus infections are the most frequent cause up to 80% of cold illnesses during the fall rhinovirus season. While viral upper respiratory infections are generally mild and self-limited, they are associated with an enormous economic burden both in lost productivity and in expenditures for treatment. Rhinovirus infection is frequently associated with medical complications that have substantial morbidity such as acute otitis media and exacerbation of asthma.

Marketed treatment options for rhinovirus consist primarily of symptomatic cold remedies have only modest effects on specific cold symptoms. 3804-250A is under investigation for the prevention of rhinovirus infection by interruption of person-to-person transmission appears to be technologically and economically feasible.

The study is a randomized, double-blind, Placebo controlled, multi-site, parallel design clinical trial conducted in the natural setting. The study will be conducted during a 10-week period during the fall rhinovirus epidemic season. Healthy, normal subjects will be recruited and randomly assigned to the AV Lotion or Placebo control group. Subjects will use the assigned test product on a defined schedule and will record the presence of cold illness symptoms daily. Subjects will return to the study site every week during the study for review and clarification of study diary entries, for review and assessment of compliance, for specimen collection for rhinovirus PCR.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-09-26
• Study First Submitted QC: 2008-09-26
• Study First Posted: 2008-09-30
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Results First Submitted: 2012-02-08
• Status Verified: 2012-03
• Results First Submitted QC: 2012-03-21
• Last Update Submitted: 2012-03-21
• Results First Posted: 2012-04-16
• Last Update Posted: 2012-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 411

Inclusion Criteria

• healthy normal
• good general health

Exclusion Criteria

• pregnancy
• insulin dependent diabetes
• daily smoker
• skin disease on the hands/wrists
• immunological disorders
• occupation involving frequent handwashing
• common cold symptoms

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	3804-291	-
3804-250A	3804-250A	-

Primary Outcome Measures

Name	Time	Method
The Primary Efficacy Endpoint of This Study is the Incidence of Cold Illnesses.	10 weeks	Comparison of the total number of incidence of cold illnesses over the course of the study per 100 subjects in each treatment group

Secondary Outcome Measures

Name	Time	Method
Rhinovirus Infections.	10 weeks	The incidence of rhinovirus infections
Rhinovirus-associated Colds	10 weeks	The incidence of rhinovirus-associated cold illnesses.

Trial Locations

Locations (2)

TKL Research, Inc.; 🇺🇸 Paramus, New Jersey, United States

University of Virginia School of Medicine; 🇺🇸 Charlottesville, Virginia, United States