NCT00895947

Brief Summary

The aim of the study is to see if lozenges containing a low dose of interferon-alpha can prevent and/or reduce the severity of colds and flu. Starting about 1 month before the expected start of the winter colds and flu season in Perth, Australia, healthy volunteers will allow a lozenge containing interferon, or a lozenge containing no medicine (a placebo), to dissolve in their mouth once a day for 16 weeks. Blood tests at the start and end of treatment will determine whether interferon was able to prevent infections with cold/flu viruses. Once a week, volunteers will complete a survey about their cold/flu symptoms, medications taken, days of work missed, etc. to see if interferon was able to make their winter colds and flu less severe.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 6, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
11 months until next milestone

Results Posted

Study results publicly available

January 13, 2011

Completed
Last Updated

September 16, 2011

Status Verified

September 1, 2011

Enrollment Period

9 months

First QC Date

May 6, 2009

Results QC Date

November 16, 2010

Last Update Submit

September 12, 2011

Conditions

Upper Respiratory Tract Infections

Keywords

ProphylaxisTreatmentSymptomsWinter Colds and Flu

Outcome Measures

Primary Outcomes (1)

  • Frequency of Influenza-like Illness

    Number of subjects in each group meeting the definition of influenza-like illness during treatment (i.e. those subject reporting one or more moderate to severe cold/flu symptoms during the treatment period).

    16 weeks

Secondary Outcomes (4)

  • Symptom Incidence/Severity

    16 weeks

  • Impact of Cold/Flu Symptoms

    16 weeks

  • Negative Events Related to Cold/Flu Symptoms

    16 weeks

  • Incidence/Severity of Viral Respiratory Infections

    16 weeks

Study Arms (2)

Interferon-alpha

EXPERIMENTAL

150 international units of interferon-alpha

Drug: interferon-alpha

placebo

PLACEBO COMPARATOR

placebo lozenges

Other: placebo

Interventions

interferon-alphaDRUG

a lozenge for oral dissolution containing 150 international units of human interferon-alpha taken once daily for 16 weeks

Also known as: IFN-alpha lozenge
Interferon-alpha
placeboOTHER

placebo lozenges for oral dissolution taken once daily for 16 weeks

Also known as: Maltose lozenge
placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or non-pregnant female
  • Females of child-bearing potential must practice a medically accepted form of birth control

You may not qualify if:

  • Currently exhibiting an acute upper respiratory tract infection
  • history of chronic respiratory disease requiring regular therapy(i.e. COPD, asthma, bronchitis, etc.)
  • any condition likely to increase the risk of severe or complicated influenza (i.e. cardiac disease, chronic renal disease, endocrine diseases, including diabetes and/or immunosuppressive therapy)
  • any condition requiring regular treatment with antihistamines, analgesics or antipyretics
  • known infection with HIV, hepatitis B virus or hepatitis C virus
  • any other serious, uncontrolled disease
  • any active infections requiring use of antibiotic or antiviral drugs
  • non-ambulatory status
  • suspected drug or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Western Australia

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Respiratory Tract InfectionsInfluenza, Human

Interventions

Interferon-alpha

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesOrthomyxoviridae InfectionsRNA Virus InfectionsVirus Diseases

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Results Point of Contact

Title
Martin J. Cummins
Organization
Amarillo Biosciences, Inc.
mcummins@amarbio.com
806-376-1741

Study Officials

  • David Smith, PhD

    Path West Laboratory Medicine WA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2009

First Posted

May 8, 2009

Study Start

April 1, 2009

Primary Completion

January 1, 2010

Study Completion

March 1, 2010

Last Updated

September 16, 2011

Results First Posted

January 13, 2011

Record last verified: 2011-09

Locations

AU(1)