Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis

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. Identifier: NCT00262405
Recruitment Status : Completed
First Posted : December 6, 2005
Last Update Posted : December 3, 2015
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Kevin R. Flaherty, University of Michigan

September 12, 2005
December 6, 2005
December 3, 2015
January 2001
May 2007   (Final data collection date for primary outcome measure)
LTB4 level in BAL [ Time Frame: 6 months ]
Not Provided
Complete list of historical versions of study NCT00262405 on Archive Site
CRP score [ Time Frame: 6 months ]
Not Provided
Not Provided
Not Provided
Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis
Phase II Trial of Zileuton Compared to Azathioprine/Prednisone for the Treatment of Idiopathic Pulmonary Fibrosis
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.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Idiopathic Pulmonary Fibrosis
  • Drug: zileuton
  • Drug: azathioprine/prednisone
  • Experimental: zileuton
    Intervention: Drug: zileuton
  • Active Comparator: azathioprine/prednisone
    Intervention: Drug: azathioprine/prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
May 2007
May 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
35 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
P50HL056402-06 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Kevin R. Flaherty, University of Michigan
University of Michigan
National Institutes of Health (NIH)
Principal Investigator: Galen B Toews, MD University of Michigan
University of Michigan
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP