Interferon Alpha Lozenges Plus Oseltamivir for Influenza Treatment

Influenza A Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01146535
• Other study ID #: QCR09025
• Status: Completed
• Phase: Phase 2
• First received: June 16, 2010
• Last updated: August 19, 2013
• Start date: January 2011
• Est. completion date: December 2012

Study information

• Verified date: August 2013
• Source: Amarillo Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationTaiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Influenza A Virus Infection
• Influenza, Human
• Virus Diseases

Intervention

Drug:
• Interferon-alpha
150 IU lozenges bid for 5 days
• Oseltamivir
75 mg capsules bid for 5 days

Other:
• maltose
200 mg maltose lozenges bid for 5 days

Locations

Country	Name	City	State
Taiwan	Show-Chwan Memorial Hospital	Changhua
Taiwan	Chang Gung Medical Foundation, LinKou Branch	Guishan	Taoyuan County
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung City	Zuoying District
Taiwan	Taiwan Municipal Hospital	Tainan

Sponsors (2)

Lead Sponsor	Collaborator
Amarillo Biosciences, Inc.	CytoPharm, Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Symptom improvement	Improvement of influenza symptoms and level of interference of disease during treatment period as reported by the subject.	Days 1-5	No
Secondary	OTC medication usage	Proportion of use of the OTC medication for fever or influenza symptoms.	Days 1-5	No
Secondary	Physician visits	Rate of requirement for additional physician visits within 5 days treatment period.	Days 6-10	No
Secondary	Treatment failure	Rate of treatment failure including hospitalization due to disease progression prior to Day 29.	Days 1-28	No