Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 14 December 2015
• Main ID: NCT00262405
• Date of registration: 12/09/2005
• Prospective Registration: No
• Primary sponsor: University of Michigan
• Public title: Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis
• Scientific title: Phase II Trial of Zileuton Compared to Azathioprine/Prednisone for the Treatment of Idiopathic Pulmonary Fibrosis
• Date of first enrolment: January 2001
• Target sample size: 44
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00262405
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Galen B Toews, MD
• Affiliation: University of Michigan

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 35 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: azathioprine/prednisone

Drug: zileuton

Primary Outcome(s)

LTB4 level in BAL [Time Frame: 6 months]

Secondary Outcome(s)

CRP score [Time Frame: 6 months]

Secondary ID(s)

P50HL056402-06

1995-0304

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institutes of Health (NIH)