Back to resultsInterferon Alpha Lozenges in the Prevention of Winter Colds and Flu
Primary Purpose
Upper Respiratory Tract Infections
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
interferon-alpha
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Upper Respiratory Tract Infections focused on measuring Prophylaxis, Treatment, Symptoms, Winter Colds and Flu
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
Sites / Locations
- University of Western Australia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Interferon-alpha
placebo
Arm Description
150 international units of interferon-alpha
placebo lozenges
Outcomes
Primary Outcome Measures
Frequency of Influenza-like Illness
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
Number of subjects in each group reporting 13 different cold/flu symptoms assessed weekly
Impact of Cold/Flu Symptoms
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
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
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
Full Information
NCT ID
NCT00895947
First Posted
May 6, 2009
Last Updated
September 12, 2011
Sponsor
Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
Collaborators
Department of Health, Western Australia
1. Study Identification
Unique Protocol Identification Number
NCT00895947
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
Collaborators
Department of Health, Western Australia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infections
Keywords
Prophylaxis, Treatment, Symptoms, Winter Colds and Flu
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interferon-alpha
Arm Type
Experimental
Arm Description
150 international units of interferon-alpha
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo lozenges
Intervention Type
Drug
Intervention Name(s)
interferon-alpha
Other Intervention Name(s)
IFN-alpha lozenge
Intervention Description
a lozenge for oral dissolution containing 150 international units of human interferon-alpha taken once daily for 16 weeks
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
Maltose lozenge
Intervention Description
placebo lozenges for oral dissolution taken once daily for 16 weeks
Primary Outcome Measure Information:
Title
Frequency of Influenza-like Illness
Description
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).
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Symptom Incidence/Severity
Description
Number of subjects in each group reporting 13 different cold/flu symptoms assessed weekly
Time Frame
16 weeks
Title
Impact of Cold/Flu Symptoms
Description
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.
Time Frame
16 weeks
Title
Negative Events Related to Cold/Flu Symptoms
Description
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
Time Frame
16 weeks
Title
Incidence/Severity of Viral Respiratory Infections
Description
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
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Smith, PhD
Organizational Affiliation
Path West Laboratory Medicine WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Western Australia
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
12. IPD Sharing Statement
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Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu
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