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Sponsored by: |
University of Michigan |
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Information provided by: | University of Michigan |
ClinicalTrials.gov Identifier: | NCT00262405 |
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.
Condition | Intervention | Phase |
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Idiopathic Pulmonary Fibrosis |
Drug: zileuton Drug: azathioprine/prednisone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II Trial of Zileuton Compared to Azathioprine/Prednisone for the Treatment of Idiopathic Pulmonary Fibrosis |
Ages Eligible for Study: | 35 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Physiologic Criteria:
Laboratory Criteria:
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | Galen B Toews, MD | University of Michigan |
Study ID Numbers: | 1995-0304 |
Study First Received: | September 12, 2005 |
Last Updated: | September 11, 2006 |
ClinicalTrials.gov Identifier: | NCT00262405 History of Changes |
Health Authority: | United States: Institutional Review Board |
Antimetabolites Anti-Inflammatory Agents Prednisone Immunologic Factors Fibrosis Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Pulmonary Fibrosis Hormones Leukotriene Antagonists Azathioprine Respiratory Tract Diseases Idiopathic Pulmonary Fibrosis |
Anti-Inflammatory Agents, Non-Steroidal Analgesics Lung Diseases, Interstitial Antineoplastic Agents, Hormonal Immunosuppressive Agents Glucocorticoids Lipoxygenase Inhibitors Analgesics, Non-Narcotic Zileuton Lung Diseases Peripheral Nervous System Agents Antirheumatic Agents |
Antimetabolites Anti-Inflammatory Agents Prednisone Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Fibrosis Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Pulmonary Fibrosis Hormones Leukotriene Antagonists Azathioprine |
Pathologic Processes Respiratory Tract Diseases Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Lung Diseases, Interstitial Antineoplastic Agents, Hormonal Enzyme Inhibitors Immunosuppressive Agents Glucocorticoids Lipoxygenase Inhibitors Pharmacologic Actions Analgesics, Non-Narcotic Zileuton |