Status:
COMPLETED
Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
35-80 years
Phase:
PHASE2
Brief Summary
Open label trial of zileuton compared to azathioprine/prednisone for patients with idiopathic pulmonary fibrosis. Study subjects will undergo a detailed clinical, radiographic, and physiologic assessm...
Eligibility Criteria
Inclusion
- Diagnosis of idiopathic pulmonary fibrosis
- Taking \< 15 mg prednisone for at least 30 days prior to screening
- Age 35-80, inclusive
- Able to understand a written informed consent and comply with the study protocol
Exclusion
- Significant environmental exposure
- Diagnosis of collagen vascular disease
- Evidence of active infection
- Clinically significant cardiac disease Myocardial infarction, coronary artery bypass or angioplasty within 6mo Unstable angina pectoris Congestive heart failure requiring hospitalization within 6 months Uncontrolled arrhythmia
- Poorly controlled or severe diabetes mellitus
- Pregnancy or lactation
- Women of childbearing potential not using a medically approved means of contraception (i.e. oral contraceptives, intrauterine devices, diaphragm, Norplant)
- Current enrollment in another experimental protocol
- Physiologic Criteria:
- FEV1/FVC \< 0.60
- Laboratory Criteria:
- Total bilirubin \> 1.5 X upper limit normal
- AST or ALT \> 3X upper limit normal
- Alkaline phosphatase \> 3X upper limit normal
- White blood cell count \< 2,500/mm3
- Hematocrit \< 30%
- Platelets \< 100,000/mm3
- Prothrombin time INR \> 1.5
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00262405
Start Date
January 1 2001
End Date
May 1 2007
Last Update
December 3 2015
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109