Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Amarillo Biosciences, Inc.
• Collaborator: Department of Health, Western Australia
• Treatments: Interferon-alpha; Interferons

Criteria

Inclusion Criteria:

• Male or non-pregnant female

• Females of child-bearing potential must practice a medically accepted form of birth control

Exclusion Criteria:

• Currently exhibiting an acute upper respiratory tract infection

• history of chronic respiratory disease requiring regular therapy(i.e. COPD, asthma, bronchitis, etc.)

• any condition likely to increase the risk of severe or complicated influenza (i.e. cardiac disease, chronic renal disease, endocrine diseases, including diabetes and/or immunosuppressive therapy)

• any condition requiring regular treatment with antihistamines, analgesics or antipyretics

• known infection with HIV, hepatitis B virus or hepatitis C virus

• any other serious, uncontrolled disease

• any active infections requiring use of antibiotic or antiviral drugs

• non-ambulatory status

• suspected drug or alcohol abuse