Interferon Alpha Lozenges Plus Oseltamivir for Influenza Treatment

Sponsor

Amarillo Biosciences, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01146535

Collaborator

CytoPharm, Inc. (Industry)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Resolution of fever and flu symptoms [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 [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 [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 [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 [Days 1-5]
Time to resolution of influenza illness (all flu symptoms and interference scored as ≤ 1) as reported by the subject.
Symptom improvement [Days 1-5]
Improvement of influenza symptoms and level of interference of disease during treatment period as reported by the subject.
OTC medication usage [Days 1-5]
Proportion of use of the OTC medication for fever or influenza symptoms.
Physician visits [Days 6-10]
Rate of requirement for additional physician visits within 5 days treatment period.
Treatment failure [Days 1-28]
Rate of treatment failure including hospitalization due to disease progression prior to Day 29.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Chang Gung Medical Foundation, LinKou Branch	Guishan	Taoyuan County	Taiwan	333
2	Kaohsiung Veterans General Hospital	Kaohsiung City	Zuoying District	Taiwan	81362
3	Show-Chwan Memorial Hospital	Changhua		Taiwan	800
4	Taiwan Municipal Hospital	Tainan		Taiwan	701