Interferon Alpha Lozenges Plus Oseltamivir for Influenza Treatment

Pilot Study of Interferon Alpha Lozenges Plus Oseltamivir in the Treatment of Influenza A Infection

This study aims to evaluate the safety and effect of interferon-alpha lozenges when used in combination with oseltamivir (Tamiflu) to treat influenza.

Study Overview

• Status: Completed
• Conditions: Influenza A Virus Infection
• Intervention / Treatment: Drug: Interferon-alpha; Drug: Oseltamivir; Other: maltose

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Changhua, Taiwan, 800
    • Show-Chwan Memorial Hospital
  • Tainan, Taiwan, 701
    • Taiwan Municipal Hospital
  • Taoyuan County
    • Guishan, Taoyuan County, Taiwan, 333
      • Chang Gung Medical Foundation, Linkou Branch
  • Zuoying District
    • Kaohsiung City, Zuoying District, Taiwan, 81362
      • Kaohsiung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interferon-alpha; Interferon-alpha 150 IU lozenges bid for 5 days	Drug: Interferon-alpha; 150 IU lozenges bid for 5 days; Other Names: IFN lozenge; Drug: Oseltamivir; 75 mg capsules bid for 5 days; Other Names: Tamiflu
Placebo Comparator: maltose; maltose 200 mg maltose lozenges bid for 5 days	Drug: Oseltamivir; 75 mg capsules bid for 5 days; Other Names: Tamiflu; Other: maltose; 200 mg maltose lozenges bid for 5 days; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
• Collaborators: CytoPharm, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: June 16, 2010
• First Submitted That Met QC Criteria: June 16, 2010
• First Posted (Estimate): June 17, 2010

Study Record Updates

• Last Update Posted (Estimate): August 21, 2013
• Last Update Submitted That Met QC Criteria: August 19, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: influenza; oseltamivir; drug therapy, combination; interferon-alpha; therapies, investigational
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Infections; Influenza, Human; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antineoplastic Agents; Immunologic Factors; Interferons; Interferon-alpha; Oseltamivir
• Other Study ID Numbers: QCR09025