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| Name | Class |
|---|---|
| Department of Health, Western Australia | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interferon-alpha | Experimental | 150 international units of interferon-alpha |
|
| placebo | Placebo Comparator | placebo lozenges |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| interferon-alpha | Drug | a lozenge for oral dissolution containing 150 international units of human interferon-alpha taken once daily for 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Incidence/Severity | Number of subjects in each group reporting 13 different cold/flu symptoms assessed weekly | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Smith, PhD | Path West Laboratory Medicine WA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Western Australia | Nedlands | Western Australia | 6009 | Australia |
Two of 200 randomized subjects (one in each group) decided not to begin study treatment after enrollment, so only 198 subjects were evaluable for response.
A total of 200 healthy volunteers were enrolled at the University of Western Australia in Perth between April 17 and July 31, 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Interferon-alpha | 150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose |
| FG001 | Placebo | 200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Interferon-alpha | 150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Intent-to-treat, defined as all randomized subjects who took at least one dose of study drug | Posted | Number | participants | 16 weeks |
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Interferon-alpha | 150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| appendectomy | Surgical and medical procedures | Non-systematic Assessment | subject underwent an emergency appendectomy judged by the attending investigator to be unrelated to study medication |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martin J. Cummins | Amarillo Biosciences, Inc. | 806-376-1741 | 14 | mcummins@amarbio.com |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D016898 | Interferon-alpha |
| ID | Term |
|---|---|
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
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| placebo | Other | placebo lozenges for oral dissolution taken once daily for 16 weeks |
|
|
| 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 | 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 | 16 weeks |
| Protocol Violation |
|
| Withdrawal by Subject |
|
200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Symptom Incidence/Severity | Number of subjects in each group reporting 13 different cold/flu symptoms assessed weekly | Posted | Number | participants | 16 weeks |
|
|
|
|
| Secondary | 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. | Posted | Number | participants | 16 weeks |
|
|
|
|
| Secondary | 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 | Posted | Number | participants | 16 weeks |
|
|
|
|
| Secondary | 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 | Posted | Number | participants | 16 weeks |
|
|
|
|
| Post-Hoc | Acute Respiratory Illness | 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." | Posted | Number | participants | 16 weeks |
|
|
|
|
| 1 |
| 99 |
| 30 |
| 99 |
| EG001 | Placebo | 200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge | 1 | 99 | 33 | 99 |
|
| hemorroidectomy | Surgical and medical procedures | Non-systematic Assessment | subject underwent an emergency hemorroidectomy judged by the attending investigator to be unrelated to study medication |
|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| fatigue | General disorders | Non-systematic Assessment |
|
| hay fever | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
| migraine | Nervous system disorders | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| moderate to severe head congestion |
|
| moderate to severe sore throat |
|
| 0.03 |
Proportion of subjects reporting moderate to severe feverishness |
| 95 |
| No |
| Superiority or Other |
| Chi-squared | 0.04 | Proportion of subjects reporting moderate to severe head congestion | 95 | No | Superiority or Other |
| Chi-squared | 0.07 | Proportion of subjects reporting moderate to severe sore throat | 95 | No | Superiority or Other |
| breathe easily |
|
| walk, climb stairs and exercise |
|
| perform daily activities |
|
| work outside the home |
|
| work inside the home |
|
| interact with others |
|
| live personal life |
|
| 0.15 |
Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to sleep well |
| 95 |
| No |
| Superiority or Other |
| Chi-squared | 0.66 | Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to breathe easily | 95 | No | Superiority or Other |
| Chi-squared | 0.48 | Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to walk, climb stairs and exercise | 95 | No | Superiority or Other |
| Chi-squared | 0.26 | Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to perform daily activities | 95 | No | Superiority or Other |
| Chi-squared | 0.25 | Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to work outside the home | 95 | No | Superiority or Other |
| Chi-squared | 0.20 | Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to work inside the home | 95 | No | Superiority or Other |
| Chi-squared | 0.20 | Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to interact with others | 95 | No | Superiority or Other |
| Chi-squared | 0.32 | Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to live personal life | 95 | No | Superiority or Other |
| visited the doctor |
|
| visited the pharmacy |
|
| took cold/flu medication |
|
| skipped a planned activity |
|
| 0.88 |
Proportion of subjects in each group reporting one or more days they missed work |
| 95 |
| No |
| Superiority or Other |
| Chi-squared | 1.0 | Proportion of subjects in each group reporting one or more days they visited the doctor | 95 | No | Superiority or Other |
| Chi-squared | 0.54 | Proportion of subjects in each group reporting one or more days they visited the pharmacy | 95 | No | Superiority or Other |
| Chi-squared | 0.24 | Proportion of subjects in each group reporting one or more days they took cold/flu medication | 95 | No | Superiority or Other |
| Chi-squared | 0.89 | Proportion of subjects in each group reporting one or more days they skipped a planned activity | 95 | No | Superiority or Other |
| moderate/severe influenza infection |
|
| moderate/severe non-influenza infection |
|
| 0.003 |
Proportion of subjects in each group with a moderate/severe viral respiratory infection |
| 95 |
| No |
| Superiority or Other |
| Chi-squared | 0.03 | Proportion of subjects in each group with a moderate/severe influenza infection | 95 | No | Superiority or Other |
| Chi-squared | 0.03 | Proportion of subjects in each group with a moderate/severe viral respiratory infection other than influenza | 95 | No | Superiority or Other |
| moderate/severe febrile ARI |
|
| moderate/severe afebrile ARI |
|
| 0.06 |
Proportion of subjects meeting with moderate/severe acute respiratory illness during treatment |
| 95 |
| No |
| Superiority or Other |
| Chi-squared | 0.03 | Proportion of subjects with moderate/severe febrile acute respiratory illness during treatment | 95 | No | Superiority or Other |
| Chi-squared | 0.60 | Proportion of subjects with moderate/severe afebrile acute respiratory illness during treatment | 95 | No | Superiority or Other |