Phase 2
N=18
Clinical Trial of Low Dose Oral Interferon Alpha in Idiopathic Pulmonary Fibrosis
Respiratory Tract Diseases · Lung Diseases · Lung Diseases, Interstitial · Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT01442779 ↗Enrolled (actual)
18
Serious AEs
22.2%
Results posted
Sep 2011
Primary outcome: Primary: Minimal/no Progression (1 yr) by High Resolution Computed Tomography (HRCT) & Pulmonary Function — 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Interferon alpha oral lozenge (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Texas Tech University Health Sciences Center
- Primary completion
- May 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Minimal/no Progression (1 yr) by High Resolution Computed Tomography (HRCT) & Pulmonary Function |
12 | — |
| PRIMARY Minimal/no Change in Quality of Life |
12 | — |
| SECONDARY Participants With Change in Cough |
5 | — |
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).
Eligibility Criteria
Inclusion Criteria
- 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.
- Exclusion of other known causes of interstitial lung disease.
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01442779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.