Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu

• 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: Amarillo Biosciences, Inc.
• Collaborator: Department of Health, Western Australia
• Information provided by (Responsible Party): Amarillo Biosciences, Inc.

Tracking Information

• First Submitted Date: May 6, 2009
• First Posted Date: May 8, 2009
• Results First Submitted Date: November 16, 2010
• Results First Posted Date: January 13, 2011
• Last Update Posted Date: September 16, 2011
• Study Start Date: April 2009
• Actual Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: May 7, 2009)

• Frequency of upper respiratory infections [ Time Frame: 16 weeks ]
• Severity of cold/flu symptoms [ Time Frame: 16 weeks ]

Current Secondary Outcome Measures (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 (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: Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Upper Respiratory Tract Infections

Intervention

• 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

• Experimental: Interferon-alpha
  150 international units of interferon-alpha
  Intervention: Drug: interferon-alpha
• Placebo Comparator: placebo
  placebo lozenges
  Intervention: Other: placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 1, 2010): 200
• Original Estimated Enrollment (submitted: May 7, 2009): 160
• Actual Study Completion Date: March 2010
• Actual Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia

Administrative Information

• NCT Number: NCT00895947
• Other Study ID Numbers: 2008-113
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Amarillo Biosciences, Inc.
• Study Sponsor: Amarillo Biosciences, Inc.
• Collaborators: Department of Health, Western Australia

Investigators

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

• PRS Account: Amarillo Biosciences, Inc.
• Verification Date: September 2011