None listed
Conditions
Brief summary
Type 1 interferons are released by cells in response to viral infections and function to limit virus replication. We propose that lozenges containing low doses of interferon can be used as an effective treatment for influenza. This grant will fund a clinical trial during the cold and flu season in Perth to test the effectiveness of this treatment AIM To conduct a clinical trial for the prophylactic use of Low Dose Orally Administered Type 1 Interferon lozenges for winter colds and flu in Perth, Western Australia The primary objective of this study is to evaluate the effect of orally administered natural human IFNa (150 IU), as compared to placebo, on the frequency and severity of winter cold and flu-like symptoms (WCFLS) during the main winter colds and flu season in Australia. Frequency and severity of WCFLS will be assessed using a questionnaire submitted on a weekly basis by study subjects. The secondary objectives will be to compare IFNa and placebo treatment with respect to changes in - days of work missed - cold/flu medication usage - number of physician visits required due to cold/flu symptoms - number of pharmacy visits required and - rates of 4-fold or greater antibody increases for a panel of respiratory viruses. Estimates of potential cost savings to the West Australian Health system following the use of interferon lozenges will be calculated based on the results of the study.
Interventions
200mg lozenge containing 150 international units Hayashibara Biochemical Laboratories.Inc, (HBL) Interferon alpha (VELDONA), administered daily for 16 weeks
Sponsors
Sir Charles Gairdner Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
healthy volunteer exposed to colds and flu through occupational or community exposure
Exclusion criteria
- 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
Outcome results
None listed