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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Common Cold

Intervention / Treatment
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* Drug: 3804-250A
* Drug: 3804-291


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: 3804-291<br>* topical apply 2 pumps apply at least every 4 hours or after hand washing<br>|
| Experimental: 3804-250A<br> | Drug: 3804-250A<br>* topical product apply 2 pumps apply at least every 4 hours or after hand washing<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cold, common, rhinovirus