Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Natural Human Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu in Perth, Western Australia

Conditions
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Upper Respiratory Tract Infections

Intervention / Treatment
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* Drug: interferon-alpha
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interferon-alpha<br>150 international units of interferon-alpha | Drug: interferon-alpha<br>* a lozenge for oral dissolution containing 150 international units of human interferon-alpha taken once daily for 16 weeks<br>* Other names: IFN-alpha lozenge;|
| Placebo Comparator: placebo<br>placebo lozenges | Other: placebo<br>* placebo lozenges for oral dissolution taken once daily for 16 weeks<br>* Other names: Maltose lozenge;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Incidence/Severity | Number of subjects in each group reporting 13 different cold/flu symptoms assessed weekly | 16 weeks | 
| 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. | 16 weeks | 
| 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 | 16 weeks | 
| 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 | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prophylaxis, Treatment, Symptoms, Winter Colds and Flu