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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Upper Respiratory Tract Infections | Drug: interferon-alpha Other: placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Evaluation of Natural Human Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu in Perth, Western Australia |
Study Start Date : | April 2009 |
Actual Primary Completion Date : | January 2010 |
Actual Study Completion Date : | March 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Interferon-alpha
150 international units of interferon-alpha
|
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 |
Placebo Comparator: placebo
placebo lozenges
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Other: placebo
placebo lozenges for oral dissolution taken once daily for 16 weeks
Other Name: Maltose lozenge |
- 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).
- 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

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00895947
Australia, Western Australia | |
University of Western Australia | |
Nedlands, Western Australia, Australia, 6009 |
Principal Investigator: | David Smith, PhD | Path West Laboratory Medicine WA |
Responsible Party: | Amarillo Biosciences, Inc. |
ClinicalTrials.gov Identifier: | NCT00895947 |
Other Study ID Numbers: |
2008-113 |
First Posted: | May 8, 2009 Key Record Dates |
Results First Posted: | January 13, 2011 |
Last Update Posted: | September 16, 2011 |
Last Verified: | September 2011 |
Prophylaxis Treatment Symptoms Winter Colds and Flu |
Respiratory Tract Infections Infection Respiratory Tract Diseases Interferons Interferon-alpha |
Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs |