Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu
- Conditions
- Upper Respiratory Tract Infections
- Interventions
- Other: placebo
- Registration Number
- NCT00895947
- Lead Sponsor
- Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Male or non-pregnant female
- Females of child-bearing potential must practice a medically accepted form of birth control
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Interferon-alpha interferon-alpha 150 international units of interferon-alpha placebo placebo placebo lozenges
- Primary Outcome Measures
Name Time Method Frequency of Influenza-like Illness 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).
- Secondary Outcome Measures
Name Time Method Symptom Incidence/Severity 16 weeks Number of subjects in each group reporting 13 different cold/flu symptoms assessed weekly
Impact of Cold/Flu Symptoms 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 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 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
Trial Locations
- Locations (1)
University of Western Australia
🇦🇺Nedlands, Western Australia, Australia