NCT01021215

Zileuton With or Without Celecoxib As Chemopreventive Agents in Smokers

Modulation of Arachidonic Acid Metabolism by Chemopreventive Agents in Smokers

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical research study is to learn how zileuton alone or the combination of zileuton and celecoxib may affect certain chemicals in the body that may be linked with a risk for smoking-related lung disease. These effects will be measured by a urine test

Detailed description

PRIMARY OBJECTIVES: I. To determine whether short-term administration of zileuton, a 5-lipoxygenase (5-LO) inhibitor, in current smokers will suppress the formation of urinary leukotriene E4 (LTE4) and shunt arachidonic acid into the cyclooxygenase (COX) pathway, resulting in elevated urinary prostaglandin E-metabolite (PGE-M). SECONDARY OBJECTIVES: I. To determine whether short-term co-administration of celecoxib, a selective COX-2 inhibitor, and zileuton suppresses levels of both urinary LTE4 and PGE-M in current smokers. II. To evaluate the association between baseline levels of urinary LTE4 and magnitude of the arachidonic acid shunt induced by zileuton. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive zileuton orally (PO) twice daily (BID) on days 1-6. ARM II: Patients receive zileuton as in Arm I and celecoxib PO BID on days 1-6.

Conditions

• Tobacco Use Disorder

Interventions

Type	Name	Description
DRUG	Zileuton	1200 mg twice daily given orally (PO) for 6 days
DRUG	Celecoxib	200 mg twice daily given orally for 6 days
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-08-01
• Completion: 2013-03-01
• First posted: 2009-11-26
• Last updated: 2015-04-02
• Results posted: 2015-04-02

Locations

2 sites across 1 country: United States