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Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Kevin R. Flaherty, University of Michigan
ClinicalTrials.gov Identifier:
NCT00262405
First received: September 12, 2005
Last updated: March 5, 2013
Last verified: March 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • LTB4 level in BAL [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CRP score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: January 2001
Study Completion Date: January 2008
Primary Completion Date: January 2008 (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

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
National Institutes of Health (NIH)
Investigators
Principal Investigator: Galen B Toews, MD University of Michigan
  More Information

No publications provided

Responsible Party: Kevin R. Flaherty, Associate Professor of Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT00262405     History of Changes
Other Study ID Numbers: 1995-0304
Study First Received: September 12, 2005
Last Updated: March 5, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013