Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu

Upper Respiratory Tract Infections Clinical Trial

Official title:

Evaluation of Natural Human Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu in Perth, Western Australia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00895947
• Other study ID #: 2008-113
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2009
• Last updated: September 12, 2011
• Start date: April 2009
• Est. completion date: March 2010

Study information

• Verified date: September 2011
• Source: Amarillo Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or non-pregnant female

• Females of child-bearing potential must practice a medically accepted form of birth control

Exclusion Criteria:

• 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

Study Design

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

Related Conditions & MeSH terms

• Respiratory Tract Infections
• Upper Respiratory Tract Infections

Intervention

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

Other:
• placebo
placebo lozenges for oral dissolution taken once daily for 16 weeks

Locations

Country	Name	City	State
Australia	University of Western Australia	Nedlands	Western Australia

Sponsors (2)

Lead Sponsor	Collaborator
Amarillo Biosciences, Inc.	Department of Health, Western Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Symptom Incidence/Severity	Number of subjects in each group reporting 13 different cold/flu symptoms assessed weekly	16 weeks	No
Secondary	Impact of Cold/Flu Symptoms	Number of subjects in each group reporting that cold/flu symptoms impacted the following 9 measures of daily life: ability to (1) think clearly, (2) sleep well, (3) breathe easily, (4) walk, climb stairs and exercise, (5) perform daily tasks, (6) work outside the home, (7) work inside the home, (8) interact with others, and (9) live personal life.	16 weeks	No
Secondary	Negative Events Related to Cold/Flu Symptoms	Number of subjects in each group reporting one or days of occurrence of the following 6 negative events: (1) felt sick, (2) missed work, (3) went to the doctor, (4) went to the pharmacy, (5) took cold/flu medication, and (6) skipped a planned activity	16 weeks	No
Secondary	Incidence/Severity of Viral Respiratory Infections	Number of subjects in each group with a confirmed viral respiratory infection and the proportion of subjects reporting a mild vs. moderate to severe infection	16 weeks	No