Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu

• ClinicalTrials.gov Identifier: NCT00895947
• Recruitment Status: Completed
• First Posted: May 8, 2009
• Results First Posted: January 13, 2011
• Last Update Posted: September 16, 2011
• Sponsor: Amarillo Biosciences, Inc.
• Collaborator: Department of Health, Western Australia
• Information provided by (Responsible Party): Amarillo Biosciences, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Upper Respiratory Tract Infections	Drug: interferon-alpha; Other: placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Evaluation of Natural Human Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu in Perth, Western Australia
• Study Start Date: April 2009
• Actual Primary Completion Date: January 2010
• Actual Study Completion Date: March 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Interferon-alpha; 150 international units of interferon-alpha	Drug: interferon-alpha; a lozenge for oral dissolution containing 150 international units of human interferon-alpha taken once daily for 16 weeks; Other Name: IFN-alpha lozenge
Placebo Comparator: placebo; placebo lozenges	Other: placebo; placebo lozenges for oral dissolution taken once daily for 16 weeks; Other Name: Maltose lozenge

Outcome Measures

Primary Outcome Measures :

1. Frequency of Influenza-like Illness [ Time Frame: 16 weeks ]
   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).

Secondary Outcome Measures :

1. Symptom Incidence/Severity [ Time Frame: 16 weeks ]
   Number of subjects in each group reporting 13 different cold/flu symptoms assessed weekly
2. Impact of Cold/Flu Symptoms [ Time Frame: 16 weeks ]
   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.
3. Negative Events Related to Cold/Flu Symptoms [ Time Frame: 16 weeks ]
   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
4. Incidence/Severity of Viral Respiratory Infections [ Time Frame: 16 weeks ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Australia, Western Australia

University of Western Australia

Nedlands, Western Australia, Australia, 6009

Sponsors and Collaborators

Amarillo Biosciences, Inc.

Department of Health, Western Australia

Investigators

• Principal Investigator: David Smith, PhD; Path West Laboratory Medicine WA

More Information

• Responsible Party: Amarillo Biosciences, Inc.
• ClinicalTrials.gov Identifier: NCT00895947
• Other Study ID Numbers: 2008-113
• First Posted: May 8, 2009
• Results First Posted: January 13, 2011
• Last Update Posted: September 16, 2011
• Last Verified: September 2011

Keywords provided by Amarillo Biosciences, Inc.:

Prophylaxis; Treatment; Symptoms; Winter Colds and Flu

Additional relevant MeSH terms:

Respiratory Tract Infections; Infection; Respiratory Tract Diseases; Interferons; Interferon-alpha; Antineoplastic Agents; Antiviral Agents; Anti-Infective Agents; Immunologic Factors; Physiological Effects of Drugs