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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00895947




Registration number
NCT00895947
Ethics application status
Date submitted
6/05/2009
Date registered
7/05/2009
Date last updated
12/09/2011

Titles & IDs
Public title
Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu
Scientific title
Evaluation of Natural Human Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu in Perth, Western Australia
Secondary ID [1] 0 0
2008-113
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper Respiratory Tract Infections 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - interferon-alpha
Other interventions - placebo

Experimental: Interferon-alpha - 150 international units of interferon-alpha

Placebo Comparator: placebo - placebo lozenges


Treatment: Drugs: interferon-alpha
a lozenge for oral dissolution containing 150 international units of human interferon-alpha taken once daily for 16 weeks

Other interventions: placebo
placebo lozenges for oral dissolution taken once daily for 16 weeks

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency of Influenza-like Illness - Number of subjects in each group meeting the definition of influenza-like illness during treatment (i.e. those subject reporting one or more moderate to severe cold/flu symptoms during the treatment period).
Timepoint [1] 0 0
16 weeks
Secondary outcome [1] 0 0
Symptom Incidence/Severity - Number of subjects in each group reporting 13 different cold/flu symptoms assessed weekly
Timepoint [1] 0 0
16 weeks
Secondary outcome [2] 0 0
Impact of Cold/Flu Symptoms - Number of subjects in each group reporting that cold/flu symptoms impacted the following 9 measures of daily life: ability to (1) think clearly, (2) sleep well, (3) breathe easily, (4) walk, climb stairs and exercise, (5) perform daily tasks, (6) work outside the home, (7) work inside the home, (8) interact with others, and (9) live personal life.
Timepoint [2] 0 0
16 weeks
Secondary outcome [3] 0 0
Negative Events Related to Cold/Flu Symptoms - Number of subjects in each group reporting one or days of occurrence of the following 6 negative events: (1) felt sick, (2) missed work, (3) went to the doctor, (4) went to the pharmacy, (5) took cold/flu medication, and (6) skipped a planned activity
Timepoint [3] 0 0
16 weeks
Secondary outcome [4] 0 0
Incidence/Severity of Viral Respiratory Infections - Number of subjects in each group with a confirmed viral respiratory infection and the proportion of subjects reporting a mild vs. moderate to severe infection
Timepoint [4] 0 0
16 weeks

Eligibility
Key inclusion criteria
- Male or non-pregnant female

- Females of child-bearing potential must practice a medically accepted form of birth
control
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
WA
Recruitment hospital [1] 0 0
University of Western Australia - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amarillo Biosciences, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Department of Health, Western Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT00895947
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Smith, PhD
Address 0 0
Path West Laboratory Medicine WA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications