Phase 2
N=200
Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu
Upper Respiratory Tract Infections
Bottom Line
View on ClinicalTrials.gov: NCT00895947 ↗Enrolled (actual)
200
Serious AEs
1.0%
Results posted
Jan 2011
Primary outcome: Primary: Frequency of Influenza-like Illness — 54; 62; 16; 28 participants — p=0.25
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- interferon-alpha (Drug); placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Influenza-like Illness |
54; 62; 16; 28; 38; 34 | 0.25 |
| SECONDARY Symptom Incidence/Severity |
86; 92; 12; 24; 23; 36 | 0.16 |
| SECONDARY Impact of Cold/Flu Symptoms |
53; 59; 54; 64; 58; 61 | 0.39 |
| SECONDARY Negative Events Related to Cold/Flu Symptoms |
62; 65; 32; 33; 16; 16 | 0.66 |
| SECONDARY Incidence/Severity of Viral Respiratory Infections |
20; 23; 5; 16; 1; 4 | 0.61 |
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.
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
Data sourced from ClinicalTrials.gov (NCT00895947). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.