Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu

September 12, 2011 updated by: Ainos, Inc. (f/k/a Amarillo Biosciences Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • University of Western Australia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • IFN-alpha lozenge
PLACEBO_COMPARATOR: placebo
placebo lozenges
Other: placebo
placebo lozenges for oral dissolution taken once daily for 16 weeks
Other Names:
  • Maltose lozenge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
16 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Department of Health, Western Australia

Investigators

  • Principal Investigator: David Smith, PhD, Path West Laboratory Medicine WA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

March 1, 2010

Study Registration Dates

First Submitted

May 6, 2009

First Submitted That Met QC Criteria

May 7, 2009

First Posted (ESTIMATE)

May 8, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 16, 2011

Last Update Submitted That Met QC Criteria

September 12, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-113

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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