Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis

Status Completed

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.

Clinical Trial Description

n/a

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

Clinical Trial Details

NCT number	NCT00262405
Study type	Interventional
Source	University of Michigan
Contact
Status	Completed
Phase	Phase 2
Start date	January 2001
Completion date	May 2007

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05984992` - The First-in-human Study of SRN-001 in Healthy Participants	Phase 1
Active, not recruiting	`NCT04312594` - Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis	Phase 2
Recruiting	`NCT03865927` - GKT137831 in IPF Patients With Idiopathic Pulmonary Fibrosis	Phase 2
Completed	`NCT03979430` - Early Detection of Acute Exacerbation in Patients With Idiopathic Lung Fibrosis - a Pilot Study	N/A
Enrolling by invitation	`NCT04905693` - Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis	Phase 3
Not yet recruiting	`NCT06241560` - A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood	Phase 2
Terminated	`NCT04419558` - Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)	Phase 3
Completed	`NCT03725852` - A Clinical Study to Test How Effective and Safe GLPG1205 is for Participants With Idiopathic Pulmonary Fibrosis (IPF)	Phase 2
Terminated	`NCT03573505` - An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis	Phase 2
Recruiting	`NCT04148157` - Quality of Life in IPF - Patient and Physician Perceptions
Completed	`NCT03222648` - Structured Exercise Training Programme in Idiopathic Pulmonary Fibrosis	N/A
Not yet recruiting	`NCT06422884` - A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial)	Phase 2
Completed	`NCT02257177` - RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF Patients	Phase 1/Phase 2
Completed	`NCT02268981` - Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF)	N/A
Withdrawn	`NCT01524068` - A MultiCenter Study of Combined PEX, Rituximab, and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations	Phase 2
Enrolling by invitation	`NCT01382368` - Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients	Phase 4
Completed	`NCT01110694` - Prospective Observation of Fibrosis in the Lung Clinical Endpoints Study
Completed	`NCT01199887` - Trial Of IW001 in Patients With Idiopathic Pulmonary Fibrosis	Phase 1
Active, not recruiting	`NCT02951416` - Clinical Course of Interstitial Lung Diseases: European IPF Registry and Biobank
Terminated	`NCT00981747` - Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis	Phase 2/Phase 3