NCT00895947

Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Ainos, Inc. (f/k/a Amarillo Biosciences Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Upper Respiratory Tract Infections

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-01-01
• Completion: 2010-03-01
• First posted: 2009-05-08
• Last updated: 2011-09-16
• Results posted: 2011-01-13

Locations

1 site across 1 country: Australia