Clinical Trial of Low Dose Oral Interferon Alpha in Idiopathic Pulmonary Fibrosis
1 other identifier
interventional
18
1 country
1
Brief Summary
The purpose of this study is to determine the possible efficacy of low dose, orally administered interferon alpha in subjects with Idiopathic Pulmonary Fibrosis (IPF).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2000
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 23, 2009
CompletedFirst Posted
Study publicly available on registry
September 29, 2011
CompletedResults Posted
Study results publicly available
September 29, 2011
CompletedApril 20, 2012
April 1, 2012
6.7 years
September 23, 2009
September 23, 2009
April 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Minimal/no Progression (1 yr) by High Resolution Computed Tomography (HRCT) & Pulmonary Function
Disease progression was determined by comparing results of the High Resolution Computed Tomography(HRCT) and pulmonary function at one year to the baseline HRCT \& pulmonary function. The same radiologist did the comparsion for all subjects.
1 yr
Minimal/no Change in Quality of Life
12 months
Secondary Outcomes (1)
Participants With Change in Cough
1 month
Interventions
dose form - oral lozenge dose - 150 International Units (IU) frequency - 3 times a day duration - at least 1 year
Eligibility Criteria
You may qualify if:
- The only subjects to be included in this study are those diagnosed with Idiopathic Pulmonary Fibrosis with diagnosis based on the criteria published by the American Thoracic Society in the International Consensus Statement.
- Abnormal pulmonary function studies.
- Bibasilar reticular abnormalities with minimal ground glass opacities on HRCT scan.
- Biopsy or lavage showing no features supporting alternative diagnosis.
- Patient older than 50 years of age.
- Insidious onset of otherwise unexplained dyspnea on exertion.
- Duration greater than 3 months.
- Bibasilar, inspiratory crackles.
You may not qualify if:
- under the age of 50
- history of hypersensitivity to interferons
- history of hypersensitivity to biological products such as vaccines
- pregnant or lactating women
- women of child bearing age not pregnancy protected during the study
- unresolved serious cardiovascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lorenz Lutherer, MD, PhD
- Organization
- Texas Tech University Health Sciences Center
Study Officials
- PRINCIPAL INVESTIGATOR
Cynthia Jumper, MD
Texas Tech University Health Sciences Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2009
First Posted
September 29, 2011
Study Start
September 1, 2000
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
April 20, 2012
Results First Posted
September 29, 2011
Record last verified: 2012-04