Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis
Status:
Completed
Trial end date:
2007-05-01
Target enrollment:
Participant gender:
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 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.