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Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu

NCT00895947 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2011-09-16

Study results available
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Summary

The aim of the study is to see if lozenges containing a low dose of interferon-alpha can prevent and/or reduce the severity of colds and flu. Starting about 1 month before the expected start of the winter colds and flu season in Perth, Australia, healthy volunteers will allow a lozenge containing interferon, or a lozenge containing no medicine (a placebo), to dissolve in their mouth once a day for 16 weeks. Blood tests at the start and end of treatment will determine whether interferon was able to prevent infections with cold/flu viruses. Once a week, volunteers will complete a survey about their cold/flu symptoms, medications taken, days of work missed, etc. to see if interferon was able to make their winter colds and flu less severe.

Conditions

  • Upper Respiratory Tract Infections

Interventions

DRUG

interferon-alpha

a lozenge for oral dissolution containing 150 international units of human interferon-alpha taken once daily for 16 weeks

OTHER

placebo

placebo lozenges for oral dissolution taken once daily for 16 weeks

Sponsors & Collaborators

  • Department of Health, Western Australia

    collaborator UNKNOWN

  • Ainos, Inc. (f/k/a Amarillo Biosciences Inc.

    lead INDUSTRY

Principal Investigators

  • David Smith, PhD · Path West Laboratory Medicine WA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-01-31
Completion
2010-03-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00895947 on ClinicalTrials.gov