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Showing 1–19 of 19 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: zileuton Clear all
Completed No phase listed Observational Results available

Association Between Increased Oxidative Stress, Anti-Inflammatory Fatty Acid Formation, and Airway Infection in People With Asthma and Chronic Obstructive Pulmonary Disease

NCT00595114
View directory record Official record
Conditions
Asthma, Pulmonary Disease, Chronic Obstructive
Interventions
Not listed
Lead sponsor
Brigham and Women's Hospital
Other
Eligibility
18 Years and older
Enrollment
43 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2009
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Oct 18, 2016 · Synced Sep 3, 2026, 1:33 AM EDT
Not listed Phase 2 Interventional

Study of Oral Zileuton in the Treatment of Moderate to Severe Facial Acne Vulgaris

NCT00098358
View directory record Official record
Conditions
Acne Vulgaris
Interventions
Zileuton
Drug
Lead sponsor
Critical Therapeutics
Industry
Eligibility
12 Years and older
Enrollment
90 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2005
U.S. locations
12
States / cities
San Diego, California • Newnan, Georgia • Louisville, Kentucky + 9 more
Source: ClinicalTrials.gov public record
Updated Feb 6, 2007 · Synced Sep 3, 2026, 1:33 AM EDT
Completed Phase 4 Interventional Results available

Single Dose Bronchodilatory Study in Asthma

NCT01805687
View directory record Official record
Conditions
Asthma
Interventions
Zileuton extended release
Drug
Lead sponsor
Cornerstone Therapeutics Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2013
U.S. locations
1
States / cities
North Dartmouth, Massachusetts
Source: ClinicalTrials.gov public record
Updated Sep 2, 2014 · Synced Sep 3, 2026, 1:33 AM EDT
Terminated Phase 4 Interventional

Zileuton CR vs Placebo in Poorly Controlled Asthma Patients on Moderate Dose ICS

NCT00486343
View directory record Official record
Conditions
Asthma
Interventions
Zileuton CR, Placebo
Drug
Lead sponsor
Critical Therapeutics
Industry
Eligibility
12 Years to 70 Years
Enrollment
400 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2008
U.S. locations
1
States / cities
Lexington, Massachusetts
Source: ClinicalTrials.gov public record
Updated Apr 2, 2008 · Synced Sep 3, 2026, 1:33 AM EDT
Terminated Phase 1Phase 2 Interventional Results available

Pilot Study of a Multi-Drug Regimen for Severe Pulmonary Fibrosis in Hermansky-Pudlak Syndrome

NCT00467831
View directory record Official record
Conditions
Hermansky-Pudlak Syndrome (HPS), Pulmonary Fibrosis, Oculocutaneous Albinism, Platelet Storage Pool Deficiency, Metabolic Disease
Interventions
Losartan, Zileuton, N-Acetylcysteine, Pravastatin, Erythromycin
Drug
Lead sponsor
National Human Genome Research Institute (NHGRI)
NIH
Eligibility
18 Years to 70 Years
Enrollment
3 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2012
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Aug 1, 2013 · Synced Sep 3, 2026, 1:33 AM EDT
Completed Early Phase 1 Interventional Accepts healthy volunteers

Evaluation of Rosiglitazone Anti-inflammatory Effect With FDG-PET Imaging

NCT01174056
View directory record Official record
Conditions
Lung Inflammation
Interventions
Zileuton, Pioglitazone placebo, Zileuton placebo, Pioglitazone
Drug
Lead sponsor
Washington University School of Medicine
Other
Eligibility
19 Years to 44 Years
Enrollment
39 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2011 – 2014
U.S. locations
1
States / cities
St Louis, Missouri
Source: ClinicalTrials.gov public record
Updated Apr 22, 2014 · Synced Sep 3, 2026, 1:33 AM EDT
Terminated Phase 1 Interventional

Evaluating the Safety of Zileuton (Zyflo®) in Combination With Dasatinib (Sprycel®) in Chronic Myelogenous Leukemia

NCT02047149
View directory record Official record
Conditions
Chronic Myelogenous Leukemia
Interventions
Zileuton (Zyflo®) Dasatinib (Sprycel®), Dosing with Zileuton/Dasatinib in CML, Daily dosing of Zileuton/Dasatinib, Daily dosing with Zileuton/Dasatinib for CML
Drug
Lead sponsor
University of Massachusetts, Worcester
Other
Eligibility
18 Years to 70 Years
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
1
States / cities
Worcester, Massachusetts
Source: ClinicalTrials.gov public record
Updated Sep 29, 2016 · Synced Sep 3, 2026, 1:33 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Zileuton With or Without Celecoxib As Chemopreventive Agents in Smokers

NCT01021215
View directory record Official record
Conditions
Tobacco Use Disorder
Interventions
Zileuton, Celecoxib, laboratory biomarker analysis
Drug · Other
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
84 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2013
U.S. locations
2
States / cities
New York, New York • Houston, Texas
Source: ClinicalTrials.gov public record
Updated Apr 1, 2015 · Synced Sep 3, 2026, 1:33 AM EDT
Completed Phase 2 Interventional Results available

PF-04191834 Single Dose Bronchodilatory Study In Asthma.

NCT00723021
View directory record Official record
Conditions
Asthma
Interventions
PF-04191834, zileuton, Placebo
Drug
Lead sponsor
Pfizer
Industry
Eligibility
18 Years to 60 Years
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
4
States / cities
Baltimore, Maryland • North Dartmouth, Massachusetts • Kalamazoo, Michigan + 1 more
Source: ClinicalTrials.gov public record
Updated Jan 31, 2013 · Synced Sep 3, 2026, 1:33 AM EDT
Completed Phase 2 Interventional

Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis

NCT00262405
View directory record Official record
Conditions
Idiopathic Pulmonary Fibrosis
Interventions
zileuton, azathioprine/prednisone
Drug
Lead sponsor
University of Michigan
Other
Eligibility
35 Years to 80 Years
Enrollment
44 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2001 – 2007
U.S. locations
1
States / cities
Ann Arbor, Michigan
Source: ClinicalTrials.gov public record
Updated Dec 2, 2015 · Synced Sep 3, 2026, 1:33 AM EDT
Terminated Phase 1 Interventional

Safety of Zileuton (Zyflo) in Combination With Imatinib Mesylate (Gleevec) in CML.

NCT01130688
View directory record Official record
Conditions
Chronic Myelogenous Leukemia
Interventions
Zileuton
Drug
Lead sponsor
University of Massachusetts, Worcester
Other
Eligibility
18 Years and older
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2014
U.S. locations
1
States / cities
Worcester, Massachusetts
Source: ClinicalTrials.gov public record
Updated May 26, 2015 · Synced Sep 3, 2026, 1:33 AM EDT
Completed Phase 1 Interventional

Trial of Zileuton CR in Children and Adults With Sickle Cell Disease

NCT01136941
View directory record Official record
Conditions
Sickle Cell Disease
Interventions
Zileuton
Drug
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Other
Eligibility
12 Years and older
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2013
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Jun 17, 2014 · Synced Sep 3, 2026, 1:33 AM EDT
Completed Phase 4 Interventional Results available

A Study Evaluating the Persistency of Response With or Without Xolair (Omalizumab) After Long-term Therapy

NCT01125748
View directory record Official record
Conditions
Allergic Asthma
Interventions
Omalizumab, Placebo, Asthma therapies
Drug
Lead sponsor
Genentech, Inc.
Industry
Eligibility
17 Years to 70 Years
Enrollment
176 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2013
U.S. locations
100
States / cities
Huntsville, Alabama • Little Rock, Arkansas • Bakersfield, California + 87 more
Source: ClinicalTrials.gov public record
Updated Oct 14, 2014 · Synced Sep 3, 2026, 1:33 AM EDT
Terminated Phase 3 Interventional Results available

Zileuton to Treat Adults With Chronic Obstructive Pulmonary Disease (The LEUKO Study)

NCT00493974
View directory record Official record
Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
Zileuton, Placebo
Drug
Lead sponsor
University of Minnesota
Other
Eligibility
45 Years and older
Enrollment
119 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2008
U.S. locations
18
States / cities
Birmingham, Alabama • Los Angeles, California • San Francisco, California + 8 more
Source: ClinicalTrials.gov public record
Updated Nov 17, 2019 · Synced Sep 3, 2026, 1:33 AM EDT
Completed Phase 4 Interventional

Zileuton and Exhaled Nitric Oxide in Asthmatics

NCT00575861
View directory record Official record
Conditions
Asthma
Interventions
zileuton
Drug
Lead sponsor
Gelb, Arthur F., M.D.
Individual
Eligibility
21 Years to 80 Years
Enrollment
19 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2007
U.S. locations
1
States / cities
Lakewood, California
Source: ClinicalTrials.gov public record
Updated Dec 19, 2007 · Synced Sep 3, 2026, 1:33 AM EDT
Completed Phase 2 Interventional

Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer

NCT00070486
View directory record Official record
Conditions
Lung Cancer
Interventions
carboplatin, celecoxib, gemcitabine hydrochloride, zileuton
Drug
Lead sponsor
Alliance for Clinical Trials in Oncology
Other
Eligibility
18 Years to 120 Years
Enrollment
140 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2011
U.S. locations
75
States / cities
Anniston, Alabama • La Jolla, California • Los Angeles, California + 55 more
Source: ClinicalTrials.gov public record
Updated Jun 29, 2016 · Synced Sep 3, 2026, 1:33 AM EDT
Completed Phase 1Phase 2 Interventional

Safety Study of Zileuton Injection in Patients With Asthma

NCT00299065
View directory record Official record
Conditions
Asthma
Interventions
Zileuton injection
Drug
Lead sponsor
Critical Therapeutics
Industry
Eligibility
12 Years and older
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006
U.S. locations
10
States / cities
Huntington Beach, California • San Diego, California • Englewood, Colorado + 7 more
Source: ClinicalTrials.gov public record
Updated Sep 25, 2007 · Synced Sep 3, 2026, 1:33 AM EDT
Completed Phase 2 Interventional

Zileuton in Preventing Lung Cancer in Patients With Bronchial Dysplasia

NCT00056004
View directory record Official record
Conditions
Head and Neck Cancer, Lung Cancer
Interventions
zileuton
Drug
Lead sponsor
Barbara Ann Karmanos Cancer Institute
Other
Eligibility
18 Years and older
Enrollment
38 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2009
U.S. locations
1
States / cities
Detroit, Michigan
Source: ClinicalTrials.gov public record
Updated Apr 28, 2013 · Synced Sep 3, 2026, 1:33 AM EDT
Completed Phase 2 Interventional Accepts healthy volunteers Results available

Aspirin and Zileuton and Biomarker Expression in Nasal Tissue of Current Smokers

NCT02348203
View directory record Official record
Conditions
Tobacco Use Disorder
Interventions
Aspirin, Laboratory Biomarker Analysis, Placebo Administration, Zileuton
Drug · Other
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
63 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016 – 2021
U.S. locations
2
States / cities
Tucson, Arizona • Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jun 1, 2022 · Synced Sep 3, 2026, 1:33 AM EDT