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Trial registered on ANZCTR


Registration number
ACTRN12609000976280
Ethics application status
Approved
Date submitted
6/04/2009
Date registered
12/11/2009
Date last updated
12/11/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of natural human interferon alpha lozenges in the prevention of winter colds and flu in Perth, Western Australia
Scientific title
Evaluation of natural human interferon alpha lozenges in the prevention of winter colds and flu amongst healthy volunteers in Perth, Western Australia
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
influenza 4571 0
common cold 4572 0
Condition category
Condition code
Infection 4864 4864 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
200mg lozenge containing 150 international units Hayashibara Biochemical Laboratories.Inc, (HBL) Interferon alpha (VELDONA), administered daily for 16 weeks
Intervention code [1] 4334 0
Prevention
Comparator / control treatment
200mg lozenge containing anhydrous crystalline maltose and 0.5% magnesium stearate, administered daily for 16 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 5718 0
frequency and severity of winter cold and flu-like symptoms monitored by weekly submission of a Health Data Questionnaire.
Timepoint [1] 5718 0
20 weeks after intervention commencement
Secondary outcome [1] 241636 0
days of work missed monitored by weekly submission of a Health Data Questionnaire.
Timepoint [1] 241636 0
20 weeks after intervention commencement
Secondary outcome [2] 241637 0
rates of 4-fold or greater antibody increases for a panel of respiratory viruses measured by serological methods. Blood collected at the start and completion of the study will be compared.
Timepoint [2] 241637 0
20 weeks after intervention commencement
Secondary outcome [3] 241638 0
number of physician visits required due to cold/flu symptoms monitored by weekly submission of a Health Data Questionnaire.
Timepoint [3] 241638 0
20 weeks after intervention commencement
Secondary outcome [4] 241639 0
cold/flu medication usage monitored by weekly submission of a Health Data Questionnaire.
Timepoint [4] 241639 0
20 weeks after intervention commencement

Eligibility
Key inclusion criteria
healthy volunteer exposed to colds and flu through occupational or community exposure
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer

The bottles containing study medications will be numbered according to the randomization scheme beginning with 001. Each of those randomization numbers will be sequentially assigned in ascending order to qualifying subjects.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using randomly permuted blocks, patients will be assigned to one of two groups: 1) 150 IU IFNa or 2) placebo
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1581 0
6009

Funding & Sponsors
Funding source category [1] 4759 0
Government body
Name [1] 4759 0
Western Australian Department of Health - State Heath Research Advisory Council (SHRAC) grant
Address [1] 4759 0
Research Development Unit
Department of Health
Level 1, 1 Centro Ave
Subiaco WA 6008
Country [1] 4759 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 4297 0
None
Name [1] 4297 0
Address [1] 4297 0
Country [1] 4297 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6802 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [1] 6802 0
1st Floor E block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA 6009
Ethics committee country [1] 6802 0
Australia
Date submitted for ethics approval [1] 6802 0
30/09/2008
Approval date [1] 6802 0
12/11/2008
Ethics approval number [1] 6802 0
2008-113

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29470 0
Address 29470 0
Country 29470 0
Phone 29470 0
Fax 29470 0
Email 29470 0
Contact person for public queries
Name 12717 0
Alayne Bennett
Address 12717 0
M502, 35 Stirling Hwy
Crawley
Western Australia 6009
Country 12717 0
Australia
Phone 12717 0
+61 8 9346 2241
Fax 12717 0
Email 12717 0
bennetta@cyllene.uwa.edu.au
Contact person for scientific queries
Name 3645 0
Dr. David Smith
Address 3645 0
2nd Floor, K block, Division of Microbiology and Infectious Diseases,
PathWest Laboratory Medicine WA,
Hospital Ave, Nedlands
Western Australia, 6009
Country 3645 0
Australia
Phone 3645 0
+61 8 9346 3122
Fax 3645 0
Email 3645 0
David.Smith@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
No Results