Clinical trial NCT00762476: Efficacy Trial of 3804-250A in the Prevention of Cold Illnesses
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Common Cold
Keywords: cold, common
rhinovirus
Lead sponsor: The Dial Corporation
Sponsor class: INDUSTRY
Collaborators: name: Hill Top Research
name: TKL Research, Inc.
First posted: 2008-09-30
Enrollment: 411
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Primary Efficacy Endpoint of This Study is the Incidence of Cold Illnesses.
timeFrame: 10 weeks
Secondary outcomes:
measure: Rhinovirus Infections.
timeFrame: 10 weeks
measure: Rhinovirus-associated Colds
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Paramus
country: United States
facility: TKL Research, Inc.
state: New Jersey
city: Charlottesville
country: United States
facility: University of Virginia School of Medicine
state: Virginia
Study officials:
affiliation: University of Virginia School of Medicine
name: Ronald B Turner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: TKL Research, Inc.
name: Michael E Casser, MD
role: PRINCIPAL_INVESTIGATOR
References: