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

May 6, 2009
September 12, 2011
April 2009
January 2010   (final data collection date for primary outcome measure)
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).
  • Frequency of upper respiratory infections [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Severity of cold/flu symptoms [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00895947 on ClinicalTrials.gov Archive Site
  • 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
  • Days of work missed [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Cold/flu medication usage [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Number of physician visits [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Number of pharmacy visits [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Hematology [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Serum biochemistry [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Adverse Events [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Upper Respiratory Tract Infections
  • 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
  • Other: placebo
    placebo lozenges for oral dissolution taken once daily for 16 weeks
    Other Name: Maltose lozenge
  • Experimental: Interferon-alpha
    150 international units of interferon-alpha
    Intervention: Drug: interferon-alpha
  • Placebo Comparator: placebo
    placebo lozenges
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
March 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00895947
2008-113
Yes
Amarillo Biosciences, Inc.
Amarillo Biosciences, Inc.
Department of Health, Western Australia
Principal Investigator: David Smith, PhD Path West Laboratory Medicine WA
Amarillo Biosciences, Inc.
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP