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| Name | Class |
|---|---|
| CytoPharm, Inc. | INDUSTRY |
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This study aims to evaluate the safety and effect of interferon-alpha lozenges when used in combination with oseltamivir (Tamiflu) to treat influenza.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interferon-alpha | Experimental | Interferon-alpha 150 IU lozenges bid for 5 days |
|
| maltose | Placebo Comparator | maltose 200 mg maltose lozenges bid for 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon-alpha | Drug | 150 IU lozenges bid for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of fever and flu symptoms | Time to resolution of influenza symptoms defined as all flu symptoms scored as <=1 and change in viral load (RT-PCR). | Days 1-5 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response | Proportion of clinical responders on Day 3 and Day 6: defined as no fever (oral temperature < 38 °C and no subjective fever) AND resolution of influenza illness (all flu symptoms and interference scored as ≤ 1). | Day 3 and Day 6 |
| Proportion of poor responders |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Medical Foundation, LinKou Branch | Guishan | Taoyuan County | 333 | Taiwan | ||
| Kaohsiung Veterans General Hospital |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D016898 | Interferon-alpha |
| D053139 | Oseltamivir |
| D008320 | Maltose |
| ID | Term |
|---|---|
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
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| Oseltamivir | Drug | 75 mg capsules bid for 5 days |
|
|
| maltose | Other | 200 mg maltose lozenges bid for 5 days |
|
|
Proportion of poor responders on both Day 3 and Day 6: defined as subjects with fever (oral temperature ≥ 38 °C or any record of subjective fever) OR unresolved influenza illness (1 or more flu symptoms/interferences scored as > 1). |
| Day 3 and Day 6 |
| Time to resolution of fever | Time to bring down a fever (oral temperature < 38 °C and no subjective fever) and time to return to afebrile state (oral temperature ≤ 37.2 °C and no subjective fever). | Days 1-5 |
| Time to resolution of influenza illness | Time to resolution of influenza illness (all flu symptoms and interference scored as ≤ 1) as reported by the subject. | Days 1-5 |
| Symptom improvement | Improvement of influenza symptoms and level of interference of disease during treatment period as reported by the subject. | Days 1-5 |
| OTC medication usage | Proportion of use of the OTC medication for fever or influenza symptoms. | Days 1-5 |
| Physician visits | Rate of requirement for additional physician visits within 5 days treatment period. | Days 6-10 |
| Treatment failure | Rate of treatment failure including hospitalization due to disease progression prior to Day 29. | Days 1-28 |
| Kaohsiung City |
| Zuoying District |
| 81362 |
| Taiwan |
| Show-Chwan Memorial Hospital | Changhua | 800 | Taiwan |
| Taiwan Municipal Hospital | Tainan | 701 | Taiwan |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D000073893 | Sugars |