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Clinical Trial of Low Dose Oral Interferon Alpha in Idiopathic Pulmonary Fibrosis

This study has been completed.
Sponsor:
Collaborator:
Amarillo Biosciences, Inc.
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01442779
First received: September 23, 2009
Last updated: April 18, 2012
Last verified: April 2012
History of Changes
Results First Received: September 23, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Respiratory Tract Diseases
Lung Diseases
Lung Diseases, Interstitial
Pulmonary Fibrosis
Intervention: Drug: Interferon alpha oral lozenge

  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
Medical clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Interferon Alpha Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.

Participant Flow:   Overall Study
    Interferon Alpha  
STARTED     18  
COMPLETED     11  
NOT COMPLETED     7  
Withdrawal by Subject                 3  
Death                 3  
Non-compliance                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Interferon Alpha Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.

Baseline Measures
    Interferon Alpha  
Number of Participants  
[units: participants]
 		  18  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     7  
>=65 years     11  
Age  
[units: years]
Mean ± Standard Deviation 		  67  ± 8.8  
Gender  
[units: participants]
 		 
Female     9  
Male     9  
Region of Enrollment  
[units: participants]
 		 
United States     18  



  Outcome Measures
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1.  Primary:   Minimal/no Progression (1 yr) by High Resolution Computed Tomography (HRCT) & Pulmonary Function   [ Time Frame: 1 yr ]
  Show Outcome Measure 1

2.  Primary:   Minimal/no Change in Quality of Life   [ Time Frame: 12 months ]
  Show Outcome Measure 2

3.  Secondary:   Participants With Change in Cough   [ Time Frame: 1 month ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Lorenz Lutherer, MD, PhD
Organization: Texas Tech University Health Sciences Center
phone: 806-743-2532
e-mail: Lorenz.Lutherer@ttuhsc.edu


No publications provided


Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01442779     History of Changes
Other Study ID Numbers: 00190
Study First Received: September 23, 2009
Results First Received: September 23, 2009
Last Updated: April 18, 2012
Health Authority: United States: Food and Drug Administration