A Phase 2 interventional study of interferon-alpha and placebo in Upper Respiratory Tract Infections, sponsored by Ainos, Inc. (f/k/a Amarillo Biosciences Inc.. Completed at 1 site in Australia. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-09-16.
Sponsored by Ainos, Inc. (f/k/a Amarillo Biosciences Inc. · Phase 2, Interventional, and Prevention
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.
1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.
This study's enrollment of 200 is close to the median of 199 across 698 interventional studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →Ainos, Inc. (f/k/a Amarillo Biosciences Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
150 international units of interferon-alpha
Drug: interferon-alpha
placebo lozenges
Other: placebo
a lozenge for oral dissolution containing 150 international units of human interferon-alpha taken once daily for 16 weeks
Also known as: IFN-alpha lozenge
placebo lozenges for oral dissolution taken once daily for 16 weeks
Also known as: Maltose lozenge
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).
Time frame: 16 weeks
Symptom Incidence/Severity
Number of subjects in each group reporting 13 different cold/flu symptoms assessed weekly
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 16 weeks
A total of 200 healthy volunteers were enrolled at the University of Western Australia in Perth between April 17 and July 31, 2009.
| Milestone | Interferon-alpha | Placebo |
|---|---|---|
| Started | 100 | 100 |
| Completed | 88 | 90 |
| Not completed | 12 | 10 |
| Withdrew: Adverse event | 3 | 4 |
| Withdrew: Lost to follow-up | 3 | 4 |
| Withdrew: Protocol violation | 4 | 2 |
| Withdrew: Withdrawal by subject | 2 | 0 |
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).
| participants | Interferon-alpha | Placebo |
|---|---|---|
| Overall | 54 | 62 |
| Age 50 and over | 16 | 28 |
| Age under 50 | 38 | 34 |
| Seasonal flu vaccine, yes | 16 | 36 |
| Seasonal flu vaccine, no | 38 | 26 |
| Gender, Male | 11 | 22 |
| Gender, Female | 43 | 40 |
Number of subjects in each group reporting 13 different cold/flu symptoms assessed weekly
| participants | Interferon-alpha | Placebo |
|---|---|---|
| any cold/flu symptoms | 86 | 92 |
| moderate to severe feverishness | 12 | 24 |
| moderate to severe head congestion | 23 | 36 |
| moderate to severe sore throat | 27 | 39 |
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.
| participants | Interferon-alpha | Placebo |
|---|---|---|
| think clearly | 53 | 59 |
| sleep well | 54 | 64 |
| breathe easily | 58 | 61 |
| walk, climb stairs and exercise | 44 | 49 |
| perform daily activities | 46 | 54 |
| work outside the home | 43 | 51 |
| work inside the home | 42 | 51 |
| interact with others | 41 | 50 |
| live personal life | 44 | 51 |
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
| participants | Interferon-alpha | Placebo |
|---|---|---|
| felt sick | 62 | 65 |
| missed work | 32 | 33 |
| visited the doctor | 16 | 16 |
| visited the pharmacy | 34 | 30 |
| took cold/flu medication | 57 | 65 |
| skipped a planned activity | 46 | 45 |
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
| participants | Interferon-alpha | Placebo |
|---|---|---|
| incidence of viral respiratory infection | 20 | 23 |
| moderate/severe viral respiratory infection | 5 | 16 |
| moderate/severe influenza infection | 1 | 4 |
| moderate/severe non-influenza infection | 4 | 11 |
Number of subjects in each group meeting definition of acute respiratory illness (ARI), defined as 2 or more cold/flu symptoms reported in the same week. Further defined as "febrile" or "afebrile" depending on whether the subject reported the symptom of "feverishness."
| participants | Interferon-alpha | Placebo |
|---|---|---|
| all acute respiratory illness (ARI) | 83 | 86 |
| moderate/severe ARI | 41 | 54 |
| moderate/severe febrile ARI | 12 | 24 |
| moderate/severe afebrile ARI | 35 | 31 |
Collected over 16 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Interferon-alpha | — | 1/99 (1%) | 30/99 (30.3%) |
| Placebo | — | 1/99 (1%) | 33/99 (33.3%) |
| Event | Interferon-alpha | Placebo |
|---|---|---|
| appendectomySurgical and medical procedures | 0/99 | 1/99 |
| hemorroidectomySurgical and medical procedures | 1/99 | 0/99 |
| Event | Interferon-alpha | Placebo |
|---|---|---|
| diarrheaGastrointestinal disorders | 14/99 | 9/99 |
| hay feverRespiratory, thoracic and mediastinal disorders | 6/99 | 13/99 |
| headacheNervous system disorders | 11/99 | 10/99 |
| fatigueGeneral disorders | 4/99 | 8/99 |
| back painMusculoskeletal and connective tissue disorders | 4/99 | 6/99 |
| nauseaGastrointestinal disorders | 5/99 | 6/99 |
| migraineNervous system disorders | 4/99 | 5/99 |
| Age, Categorical(Participants) | Interferon-alpha | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 95 | 91 | 186 |
| >=65 years | 5 | 9 | 14 |
| Age Continuous(years) | Interferon-alpha | Placebo | Total |
|---|---|---|---|
| Mean | 45.0 ± 14.4 | 47.3 ± 13.2 | 46.2 ± 14.2 |
| Sex: Female, Male(Participants) | Interferon-alpha | Placebo | Total |
|---|---|---|---|
| Female | 70 | 66 | 136 |
| Male | 30 | 34 | 64 |
| Region of Enrollment(participants) | Interferon-alpha | Placebo | Total |
|---|---|---|---|
| Australia | 100 | 100 | 200 |
This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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Ainos, Inc. (f/k/a Amarillo Biosciences Inc.