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Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00895947
Recruitment Status : Completed
First Posted : May 8, 2009
Results First Posted : January 13, 2011
Last Update Posted : September 16, 2011
Department of Health, Western Australia
Information provided by (Responsible Party):
Amarillo Biosciences, Inc.

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.

Condition or disease Intervention/treatment Phase
Upper Respiratory Tract Infections Drug: interferon-alpha Other: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Natural Human Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu in Perth, Western Australia
Study Start Date : April 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu
Drug Information available for: Interferon

Arm Intervention/treatment
Experimental: Interferon-alpha
150 international units of interferon-alpha
Drug: interferon-alpha
a lozenge for oral dissolution containing 150 international units of human interferon-alpha taken once daily for 16 weeks
Other Name: IFN-alpha lozenge

Placebo Comparator: placebo
placebo lozenges
Other: placebo
placebo lozenges for oral dissolution taken once daily for 16 weeks
Other Name: Maltose lozenge

Primary Outcome Measures :
  1. Frequency of Influenza-like Illness [ Time Frame: 16 weeks ]
    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).

Secondary Outcome Measures :
  1. Symptom Incidence/Severity [ Time Frame: 16 weeks ]
    Number of subjects in each group reporting 13 different cold/flu symptoms assessed weekly

  2. Impact of Cold/Flu Symptoms [ Time Frame: 16 weeks ]
    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.

  3. Negative Events Related to Cold/Flu Symptoms [ Time Frame: 16 weeks ]
    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

  4. Incidence/Severity of Viral Respiratory Infections [ Time Frame: 16 weeks ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00895947

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Australia, Western Australia
University of Western Australia
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Amarillo Biosciences, Inc.
Department of Health, Western Australia
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Principal Investigator: David Smith, PhD Path West Laboratory Medicine WA
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Responsible Party: Amarillo Biosciences, Inc. Identifier: NCT00895947    
Other Study ID Numbers: 2008-113
First Posted: May 8, 2009    Key Record Dates
Results First Posted: January 13, 2011
Last Update Posted: September 16, 2011
Last Verified: September 2011
Keywords provided by Amarillo Biosciences, Inc.:
Winter Colds and Flu
Additional relevant MeSH terms:
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Respiratory Tract Infections
Respiratory Tract Diseases
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs