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Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00262405
First Posted: December 6, 2005
Last Update Posted: December 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Kevin R. Flaherty, University of Michigan
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Zileuton Compared to Azathioprine/Prednisone for the Treatment of Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:


Further study details as provided by Kevin R. Flaherty, University of Michigan:

Primary Outcome Measures:
  • LTB4 level in BAL [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • CRP score [ Time Frame: 6 months ]

Enrollment: 44
Study Start Date: January 2001
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: zileuton
Zileuton
Drug: zileuton
Active Comparator: azathioprine/prednisone
azathioprine/prednisone
Drug: azathioprine/prednisone

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00262405


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institutes of Health (NIH)
Investigators
Principal Investigator: Galen B Toews, MD University of Michigan
  More Information

Responsible Party: Kevin R. Flaherty, Professor of Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT00262405     History of Changes
Other Study ID Numbers: 1995-0304
P50HL056402-06 ( U.S. NIH Grant/Contract )
First Submitted: September 12, 2005
First Posted: December 6, 2005
Last Update Posted: December 3, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Zileuton
Prednisone
Azathioprine
Hydroxyurea
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents