Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis

Sponsor

University of Michigan (Other)

Overall Status

Completed

CT.gov ID

NCT00262405

Collaborator

National Institutes of Health (NIH) (NIH)

Enrollment

Location

Arms

75.9

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis	Drug: zileuton Drug: azathioprine/prednisone	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

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

Study Start Date :

Jan 1, 2001

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

May 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: zileuton Zileuton	Drug: zileuton
Active Comparator: azathioprine/prednisone azathioprine/prednisone	Drug: azathioprine/prednisone

Arm

Intervention/Treatment

Experimental: zileuton

Zileuton

Drug: zileuton

Active Comparator: azathioprine/prednisone

azathioprine/prednisone

Drug: azathioprine/prednisone

Outcome Measures

Primary Outcome Measures

LTB4 level in BAL [6 months]

Secondary Outcome Measures

CRP score [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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