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Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu

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ClinicalTrials.gov Identifier: NCT00895947
Recruitment Status : Completed
First Posted : May 8, 2009
Results First Posted : January 13, 2011
Last Update Posted : September 16, 2011
Sponsor:
Collaborator:
Department of Health, Western Australia
Information provided by (Responsible Party):
Amarillo Biosciences, Inc.

Tracking Information
First Submitted Date  ICMJE May 6, 2009
First Posted Date  ICMJE May 8, 2009
Results First Submitted Date  ICMJE November 16, 2010
Results First Posted Date  ICMJE January 13, 2011
Last Update Posted Date September 16, 2011
Study Start Date  ICMJE April 2009
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2010)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2009)
  • Frequency of upper respiratory infections [ Time Frame: 16 weeks ]
  • Severity of cold/flu symptoms [ Time Frame: 16 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2010)
  • Symptom Incidence/Severity [ Time Frame: 16 weeks ]
    Number of subjects in each group reporting 13 different cold/flu symptoms assessed weekly
  • 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.
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2009)
  • Days of work missed [ Time Frame: 16 weeks ]
  • Cold/flu medication usage [ Time Frame: 16 weeks ]
  • Number of physician visits [ Time Frame: 16 weeks ]
  • Number of pharmacy visits [ Time Frame: 16 weeks ]
  • Hematology [ Time Frame: 16 weeks ]
  • Serum biochemistry [ Time Frame: 16 weeks ]
  • Adverse Events [ Time Frame: 16 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu
Official Title  ICMJE Evaluation of Natural Human Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu in Perth, Western Australia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Upper Respiratory Tract Infections
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Interferon-alpha
    150 international units of interferon-alpha
    Intervention: Drug: interferon-alpha
  • Placebo Comparator: placebo
    placebo lozenges
    Intervention: Other: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2010)
200
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2009)
160
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00895947
Other Study ID Numbers  ICMJE 2008-113
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amarillo Biosciences, Inc.
Study Sponsor  ICMJE Amarillo Biosciences, Inc.
Collaborators  ICMJE Department of Health, Western Australia
Investigators  ICMJE
Principal Investigator: David Smith, PhD Path West Laboratory Medicine WA
PRS Account Amarillo Biosciences, Inc.
Verification Date September 2011

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