Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu

Ainos

Status and phase

Completed

Phase 2

Conditions

Upper Respiratory Tract Infections

Treatments

Drug: interferon-alpha

Other: placebo

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT00895947

2008-113

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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