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Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis

NCT ID: NCT00262405

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2007-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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zileuton

Zileuton

Group Type EXPERIMENTAL

zileuton

Intervention Type DRUG

azathioprine/prednisone

azathioprine/prednisone

Group Type ACTIVE_COMPARATOR

azathioprine/prednisone

Intervention Type DRUG

Interventions

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zileuton

Intervention Type DRUG

azathioprine/prednisone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Kevin R. Flaherty

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Galen B Toews, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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P50HL056402-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1995-0304

Identifier Type: -

Identifier Source: org_study_id