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

A MULTI-CENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE II EFFICACY TRIAL OF AV LOTION (FORMULA NO. 3804-250A) FOR THE PREVENTION OF COLD ILLNESS IN HUMAN SUBJECTS

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.

Study Overview

• Status: Completed
• Conditions: Common Cold
• Intervention / Treatment: Drug: 3804-291; Drug: 3804-250A

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 Type: Interventional
• Enrollment (Actual): 411
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Paramus, New Jersey, United States, 07652
      • TKL Research, Inc.
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: 3804-291; topical; apply 2 pumps; apply at least every 4 hours or after hand washing
EXPERIMENTAL: 3804-250A	Drug: 3804-250A; topical product; apply 2 pumps; apply at least every 4 hours or after hand washing

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rhinovirus Infections.	The incidence of rhinovirus infections	10 weeks
Rhinovirus-associated Colds	The incidence of rhinovirus-associated cold illnesses.	10 weeks

Collaborators and Investigators

• Sponsor: The Dial Corporation
• Collaborators: TKL Research, Inc.; Hill Top Research
• Investigators: Principal Investigator: Ronald B Turner, MD, University of Virginia School of Medicine

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (ACTUAL): November 1, 2008
• Study Completion (ACTUAL): November 1, 2008

Study Registration Dates

• First Submitted: September 26, 2008
• First Submitted That Met QC Criteria: September 26, 2008
• First Posted (ESTIMATE): September 30, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): April 16, 2012
• Last Update Submitted That Met QC Criteria: March 21, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: rhinovirus; cold, common
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Picornaviridae Infections; Common Cold
• Other Study ID Numbers: TM&R-0062-08-TXC; CS990108; 13805