Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis

NCT00262405 | Completed Phase 2

• 2 other identifiers: 1995-0304P50HL056402-06
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• LTB4 level in BAL

  6 months

Secondary Outcomes (1)

• CRP score

  6 months

Study Arms (2)

zileuton

EXPERIMENTAL

Zileuton

Drug: zileuton

azathioprine/prednisone

ACTIVE COMPARATOR

azathioprine/prednisone

Drug: azathioprine/prednisone

Interventions

zileuton DRUG

zileuton

azathioprine/prednisone DRUG

azathioprine/prednisone

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

zileuton; Azathioprine; Prednisone

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thionucleosides; Sulfur Compounds; Organic Chemicals; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Galen B Toews, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: December 6, 2005
• Study Start: January 1, 2001
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

US (1)