Evaluation of natural human interferon alpha lozenges in the prevention of winter colds and flu in Perth, Western Australia
- Conditions
- influenzacommon coldInfection - Other infectious diseases
- Registration Number
- ACTRN12609000976280
- Lead Sponsor
- Sir Charles Gairdner Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
healthy volunteer exposed to colds and flu through occupational or community exposure
- is currently exhibiting an acute upper respiratory tract infection
- has a history of a chronic respiratory disease such as asthma requiring any form of regular therapy, bronchitis, Chronic Obstructive Pulmonary Disease (COPD), etc
- has any other condition likely to increase the risk of severe or complicated influenza, as outlined in the Australian Immunisation Guidelines (8th ed) such as chronic cardiac diseases, chronic renal disease, endocrine diseases (including diabetes) and immunosuppressive therapy.
- any neurological, psychiatric or psychological condition requiring regular medical attention.
- any other serious, uncontrolled disease.
- any condition requiring regular treatment with antihistamines, or analgesics/antipyretics (including aspirin, paracetemol and non-steroidal anti-inflammatory drugs.
- has participated in another clinical trial during the last 12 weeks
- has hypersensitivity to Interferon alpha (IFNa)
- has known contraindication to any component of IFNa or the placebo
- has a concurrent diseases which exclude the administration of therapy as outlined by the study protocol
- has active infections requiring systemically administered antibiotics or antiviral medications
- has any abnormalities o the screening tests for hepatic, renal and haemtological function.
- is non-ambulatory
- is a women who is lactating, pregnant or of childbearing potential and not using a reliable contraceptive method
- has known Human Immunodeficiency Virus (HIV) or active chronic hepatitis B or C infection
- is a subject who, in the opinion of the investigator, is not likely to complete the study for what ever reason.
- is a subject who, in the opinion of the investigator, abuses alcohol or drugs
- has had previous exposure to parenteral interferon therapy within 12 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method