Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00262405
• Other study ID #: 1995-0304
• Secondary ID: P50HL056402-06
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: December 2, 2015
• Start date: January 2001
• Est. completion date: May 2007

Study information

• Verified date: December 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• zileuton

• azathioprine/prednisone

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LTB4 level in BAL		6 months	No
Secondary	CRP score		6 months	No