Upper Respiratory Tract InfectionsPhase 2NCT00895947
Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu
A Phase 2 study testing interferon-alpha in people with Upper Respiratory Tract Infections, run by Ainos, Inc. (f/k/a Amarillo Biosciences Inc. at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infections
- What is being tested?
- interferon-alpha
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2009to Mar 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female
- Females of child-bearing potential must practice a medically accepted form of birth control
Who cannot join
- 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
Show all 9Show fewer
- any active infections requiring use of antibiotic or antiviral drugs
- non-ambulatory status
- suspected drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
Australia1 site
University of Western Australia
Nedlands, Western Australia, 6009
About this study
Official title: Evaluation of Natural Human Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu in Perth, Western Australia
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.
- Conditions
- Upper Respiratory Tract Infections
- Being tested
- interferon-alpha, placebo
- Keywords
- Prophylaxis, Treatment, Symptoms, Winter Colds and Flu
- Medical subject headings
- Respiratory Tract Infections, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interferon-alphaDrug
Also called IFN-alpha lozenge
a lozenge for oral dissolution containing 150 international units of human interferon-alpha taken once daily for 16 weeks
placeboOther
Also called Maltose lozenge
placebo lozenges for oral dissolution taken once daily for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Interferon-alpha | Experimental | 150 international units of interferon-alpha Receives: Drug: interferon-alpha |
| placebo | Placebo comparator | placebo lozenges Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 16 weeks
Secondary outcomes (4)
Symptom Incidence/Severity
Number of subjects in each group reporting 13 different cold/flu symptoms assessed weekly
Measured: 16 weeks
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.
Measured: 16 weeks
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
Measured: 16 weeks
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
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startApr 2009
- Primary completionJan 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Upper Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Department of Health, Western Australia
- Responsible party
- Sponsor
- Investigators
- David Smith, PhD, Principal investigator, Path West Laboratory Medicine WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895947
- Sponsor's protocol ID
- 2008-113
- Status last verified
- Sep 2011
- First submitted
- 6 May 2009
- Last updated
- 16 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Natural Human Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu in Perth, Western Australia
- ClinicalTrials.gov ID
- NCT00895947
- Acronym / sponsor ID
- 2008-113
- Conditions
- Upper Respiratory Tract Infections
- Keywords
- Prophylaxis, Treatment, Symptoms, Winter Colds and Flu
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ainos, Inc. (f/k/a Amarillo Biosciences Inc.Industry (pharma, biotech, devices)
- Collaborators
- Department of Health, Western Australia
- Study start
- Apr 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 8 May 2009 (estimated)
- Results
- Posted 13 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interferon-alpha | Experimental | Drug: interferon-alpha150 international units of interferon-alpha |
| placebo | Placebo comparator | Other: placeboplacebo lozenges |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or non-pregnant female
- Females of child-bearing potential must practice a medically accepted form of birth control
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interferon-alphaAlso: IFN-alpha lozengea lozenge for oral dissolution containing 150 international units of human interferon-alpha taken once daily for 16 weeks | Drug | Interferon-alpha |
| placeboAlso: Maltose lozengeplacebo lozenges for oral dissolution taken once daily for 16 weeks | Other | placebo |
Primary outcome
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).
4 secondary outcomes
Symptom Incidence/Severity
Time frame: 16 weeks
Impact of Cold/Flu Symptoms
Time frame: 16 weeks
Negative Events Related to Cold/Flu Symptoms
Time frame: 16 weeks
Incidence/Severity of Viral Respiratory Infections
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Smith, PhD principal investigator
Path West Laboratory Medicine WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing interferon-alpha in people with Upper Respiratory Tract Infections, run by Ainos, Inc. (f/k/a Amarillo Biosciences Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Influenza-like Illness (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2011.