Interferon Alpha Lozenges Plus Oseltamivir for Influenza Treatment - Full Text View

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Fever Flu

Drug Information available for: Interferon Interferon Alfa-2a Oseltamivir Oseltamivir phosphate

U.S. FDA Resources

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

Primary Outcome Measures:

Resolution of fever and flu symptoms [ Time Frame: Days 1-5 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Proportion of use of the OTC medication for fever or influenza symptoms.
Physician visits [ Time Frame: Days 6-10 ] [ Designated as safety issue: No ]
Rate of requirement for additional physician visits within 5 days treatment period.
Treatment failure [ Time Frame: Days 1-28 ] [ Designated as safety issue: No ]
Rate of treatment failure including hospitalization due to disease progression prior to Day 29.

Estimated Enrollment:	60
Study Start Date:	January 2011
Estimated Study Completion Date:	December 2012
Estimated 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

Ages Eligible for Study:	20 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Amarillo Biosciences, Inc.
ClinicalTrials.gov Identifier:	NCT01146535 History of Changes
Other Study ID Numbers:	QCR09025
Study First Received:	June 16, 2010
Last Updated:	August 6, 2012
Health Authority:	United States: Food and Drug Administration Taiwan: Department of Health

Keywords provided by Amarillo Biosciences, Inc.:

interferon-alpha
oseltamivir
drug therapy, combination
influenza
therapies, investigational

Additional relevant MeSH terms:

Influenza, Human
Virus Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Interferon-alpha
Interferon Alfa-2a
Interferons
Oseltamivir
Antiviral Agents
Anti-Infective Agents

Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013