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Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu

This study has been completed.
Sponsor:
Collaborator:
Department of Health, Western Australia
Information provided by (Responsible Party):
Amarillo Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT00895947
First received: May 6, 2009
Last updated: September 12, 2011
Last verified: September 2011
Results First Received: November 16, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Upper Respiratory Tract Infections
Interventions: Drug: interferon-alpha
Other: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 200 healthy volunteers were enrolled at the University of Western Australia in Perth between April 17 and July 31, 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two of 200 randomized subjects (one in each group) decided not to begin study treatment after enrollment, so only 198 subjects were evaluable for response.

Reporting Groups
  Description
Interferon-alpha 150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
Placebo 200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge

Participant Flow:   Overall Study
    Interferon-alpha   Placebo
STARTED   100   100 
COMPLETED   88   90 
NOT COMPLETED   12   10 
Adverse Event                3                4 
Lost to Follow-up                3                4 
Protocol Violation                4                2 
Withdrawal by Subject                2                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Interferon-alpha 150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
Placebo 200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
Total Total of all reporting groups

Baseline Measures
   Interferon-alpha   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 100   100   200 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   95   91   186 
>=65 years   5   9   14 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.0  (14.4)   47.3  (13.2)   46.2  (14.2) 
Gender 
[Units: Participants]
     
Female   70   66   136 
Male   30   34   64 
Region of Enrollment 
[Units: Participants]
     
Australia   100   100   200 


  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Symptom Incidence/Severity   [ Time Frame: 16 weeks ]

3.  Secondary:   Impact of Cold/Flu Symptoms   [ Time Frame: 16 weeks ]

4.  Secondary:   Negative Events Related to Cold/Flu Symptoms   [ Time Frame: 16 weeks ]

5.  Secondary:   Incidence/Severity of Viral Respiratory Infections   [ Time Frame: 16 weeks ]

6.  Post-Hoc:   Acute Respiratory Illness   [ Time Frame: 16 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Martin J. Cummins
Organization: Amarillo Biosciences, Inc.
phone: 806-376-1741 ext 14
e-mail: mcummins@amarbio.com



Responsible Party: Amarillo Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00895947     History of Changes
Other Study ID Numbers: 2008-113
Study First Received: May 6, 2009
Results First Received: November 16, 2010
Last Updated: September 12, 2011
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration