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Interferon Alpha Lozenges Plus Oseltamivir for Influenza Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01146535
First Posted: June 17, 2010
Last Update Posted: August 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
CytoPharm, Inc.
Information provided by (Responsible Party):
Amarillo Biosciences, Inc.
  Purpose
This study aims to evaluate the safety and effect of interferon-alpha lozenges when used in combination with oseltamivir (Tamiflu) to treat influenza.

Condition Intervention Phase
Influenza A Virus Infection Drug: Interferon-alpha Drug: Oseltamivir Other: maltose Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of Interferon Alpha Lozenges Plus Oseltamivir in the Treatment of Influenza A Infection

Resource links provided by NLM:


Further study details as provided by Amarillo Biosciences, Inc.:

Primary Outcome Measures:
  • Resolution of fever and flu symptoms [ Time Frame: Days 1-5 ]
    Time to resolution of influenza symptoms defined as all flu symptoms scored as <=1 and change in viral load (RT-PCR).


Secondary Outcome Measures:
  • Clinical response [ Time Frame: Day 3 and Day 6 ]
    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).

  • Proportion of poor responders [ Time Frame: Day 3 and Day 6 ]
    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).

  • Time to resolution of fever [ Time Frame: Days 1-5 ]
    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).

  • Time to resolution of influenza illness [ Time Frame: Days 1-5 ]
    Time to resolution of influenza illness (all flu symptoms and interference scored as ≤ 1) as reported by the subject.

  • Symptom improvement [ Time Frame: Days 1-5 ]
    Improvement of influenza symptoms and level of interference of disease during treatment period as reported by the subject.

  • OTC medication usage [ Time Frame: Days 1-5 ]
    Proportion of use of the OTC medication for fever or influenza symptoms.

  • Physician visits [ Time Frame: Days 6-10 ]
    Rate of requirement for additional physician visits within 5 days treatment period.

  • Treatment failure [ Time Frame: Days 1-28 ]
    Rate of treatment failure including hospitalization due to disease progression prior to Day 29.


Enrollment: 40
Study Start Date: January 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interferon-alpha

Interferon-alpha

150 IU lozenges bid for 5 days

Drug: Interferon-alpha
150 IU lozenges bid for 5 days
Other Name: IFN lozenge
Drug: Oseltamivir
75 mg capsules bid for 5 days
Other Name: Tamiflu
Placebo Comparator: maltose

maltose

200 mg maltose lozenges bid for 5 days

Drug: Oseltamivir
75 mg capsules bid for 5 days
Other Name: Tamiflu
Other: maltose
200 mg maltose lozenges bid for 5 days
Other Name: placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • fever >=38C
  • one or more respiratory symptoms (e.g. cough, rhinorrhea or sore throat) plus one or more constitutional symptoms (e.g. chills, headache, malaise and myalgias)of < 48 hours' duration
  • body weight > 40 kg
  • positive for influenza A (nasal swab rapid test)

Exclusion Criteria:

  • pregnancy/lactation
  • history of depression or psychiatric disorders
  • history of conditions that could complicate flu infection, such as chronic pulmonary, cardiac, renal, or metabolic disorders
  • use of immunosuppressive therapy
  • HIV infection
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01146535


Locations
Taiwan
Chang Gung Medical Foundation, LinKou Branch
Guishan, Taoyuan County, Taiwan, 333
Kaohsiung Veterans General Hospital
Kaohsiung City, Zuoying District, Taiwan, 81362
Show-Chwan Memorial Hospital
Changhua, Taiwan, 800
Taiwan Municipal Hospital
Tainan, Taiwan, 701
Sponsors and Collaborators
Amarillo Biosciences, Inc.
CytoPharm, Inc.
  More Information

Responsible Party: Amarillo Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01146535     History of Changes
Other Study ID Numbers: QCR09025
First Submitted: June 16, 2010
First Posted: June 17, 2010
Last Update Posted: August 21, 2013
Last Verified: August 2013

Keywords provided by Amarillo Biosciences, Inc.:
interferon-alpha
oseltamivir
drug therapy, combination
influenza
therapies, investigational

Additional relevant MeSH terms:
Infection
Influenza, Human
Virus Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Interferons
Interferon-alpha
Oseltamivir
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action