Common Cold Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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