Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis
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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.
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Ages Eligible for Study:
35 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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