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Completed

NCT Number: NCT00895947

Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu

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.

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Key information

Conditions

Upper Respiratory Tract Infections Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Western Australia

Nedlands, Western Australia, 6009, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interferon-alpha

Drug

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

Other names: IFN-alpha lozenge

Placebo

Other

placebo lozenges for oral dissolution taken once daily for 16 weeks

Other names: Maltose lozenge

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ainos, Inc. (f/k/a Amarillo Biosciences Inc.

Industry

Collaborators

  • Department of Health, Western Australia

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 8, 2009
Registry last updated
Sep 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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