Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis

Study Overview
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Brief Summary
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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 assessment at baseline. Subjects will be monitored off treatment for three months for changes in symptoms and physiology. Subjects will then be randomized to six months of treatment with zileuton or azathioprine/prednisone. The primary endpoint of this trial is change in LTB4 levels in bronchoalveolar lavage fluid following six months of treatment. Secondary endpoints are progression free survival, change in dyspnea, change in quality of life, and change in physiology.

Official Title
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Phase II Trial of Zileuton Compared to Azathioprine/Prednisone for the Treatment of Idiopathic Pulmonary Fibrosis

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: zileuton
* Drug: azathioprine/prednisone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: zileuton<br>Zileuton | Drug: zileuton<br> <br> |
| Active Comparator: azathioprine/prednisone<br>azathioprine/prednisone | Drug: azathioprine/prednisone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LTB4 level in BAL |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRP score |  | 6 months |