Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis

This study has been completed.

Sponsor:

Collaborator:

National Institutes of Health (NIH)

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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

March 5, 2013

Start Date ^ICMJE

January 2001

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

LTB4 level in BAL [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00262405 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

CRP score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis

Official Title ^ICMJE

Phase II Trial of Zileuton Compared to Azathioprine/Prednisone for the Treatment of Idiopathic Pulmonary Fibrosis

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Idiopathic Pulmonary Fibrosis

Intervention ^ICMJE

Drug: zileuton
Drug: azathioprine/prednisone

Study Arm (s)

Experimental: zileuton
Zileuton

Intervention: Drug: zileuton
Active Comparator: azathioprine/prednisone
azathioprine/prednisone

Intervention: Drug: azathioprine/prednisone

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

35 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00262405

Other Study ID Numbers ^ICMJE

1995-0304

Has Data Monitoring Committee

Not Provided

Responsible Party

Kevin R. Flaherty, University of Michigan

Study Sponsor ^ICMJE

University of Michigan

Collaborators ^ICMJE

National Institutes of Health (NIH)

Investigators ^ICMJE

Principal Investigator:

Galen B Toews, MD

University of Michigan

Information Provided By

University of Michigan

Verification Date

March 2013

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

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