Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis - Full Text View

Sponsored by:	University of Michigan
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00262405

Purpose

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
Idiopathic Pulmonary Fibrosis	Drug: zileuton Drug: azathioprine/prednisone	Phase II

MedlinePlus related topics: Pulmonary Fibrosis

Drug Information available for: Prednisone Azathioprine Azathioprine sodium salt Zileuton

U.S. FDA Resources

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

Further study details as provided by University of Michigan:

Estimated Enrollment:	140
Study Start Date:	January 2001

Eligibility

Ages Eligible for Study:	35 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262405

Locations

United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan

Investigators

Principal Investigator:

Galen B Toews, MD

University of Michigan

More Information

Study ID Numbers:	1995-0304
Study First Received:	September 12, 2005
Last Updated:	September 11, 2006
ClinicalTrials.gov Identifier:	NCT00262405
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Prednisone
Lung Diseases, Interstitial
Azathioprine
Respiratory Tract Diseases
Fibrosis

Zileuton
Hamman-Rich syndrome
Lung Diseases
Pulmonary Fibrosis
Leukotriene Antagonists

Additional relevant MeSH terms:

Antimetabolites
Anti-Inflammatory Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pathologic Processes
Sensory System Agents
Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Antineoplastic Agents, Hormonal
Enzyme Inhibitors
Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions
Lipoxygenase Inhibitors
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009