Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu

This study has been completed.
Sponsor:
Collaborator:
Department of Health, Western Australia
Information provided by (Responsible Party):
Amarillo Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT00895947
First received: May 6, 2009
Last updated: September 12, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Upper Respiratory Tract Infections
Drug: interferon-alpha
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Amarillo Biosciences, Inc.:

Primary Outcome Measures:
  • Frequency of Influenza-like Illness [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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:
  • Symptom Incidence/Severity [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Number of subjects in each group reporting 13 different cold/flu symptoms assessed weekly

  • Impact of Cold/Flu Symptoms [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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.

  • Negative Events Related to Cold/Flu Symptoms [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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

  • Incidence/Severity of Viral Respiratory Infections [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 200
Study Start Date: April 2009
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00895947

Locations
Australia, Western Australia
University of Western Australia
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Amarillo Biosciences, Inc.
Department of Health, Western Australia
Investigators
Principal Investigator: David Smith, PhD Path West Laboratory Medicine WA
  More Information

No publications provided

Responsible Party: Amarillo Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00895947     History of Changes
Other Study ID Numbers: 2008-113
Study First Received: May 6, 2009
Results First Received: November 16, 2010
Last Updated: September 12, 2011
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Amarillo Biosciences, Inc.:
Prophylaxis
Treatment
Symptoms
Winter Colds and Flu

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Interferon-alpha
Interferon Alfa-2a
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 16, 2014