Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis

This study has been completed.
Sponsor:
Collaborator:
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

September 12, 2005
March 5, 2013
January 2001
January 2008   (final data collection date for primary outcome measure)
LTB4 level in BAL [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00262405 on ClinicalTrials.gov Archive Site
CRP score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Idiopathic Pulmonary Fibrosis
  • Drug: zileuton
  • Drug: azathioprine/prednisone
  • Experimental: zileuton
    Zileuton
    Intervention: Drug: zileuton
  • Active Comparator: azathioprine/prednisone
    azathioprine/prednisone
    Intervention: Drug: azathioprine/prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
January 2008
January 2008   (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
Both
35 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00262405
1995-0304
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
March 2013

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