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

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Chronic obstructive pulmonary disease (COPD) is a long-term lung disease that is caused by cigarette smoking or by breathing in other lung irritants, including pollution, dust, or chemicals. The purpose of this study is to evaluate the effectiveness of zileuton, a medication that is used to control asthma symptoms, at reducing the length of a hospital stay for adults who are hospitalized for a COPD exacerbation, or worsening of COPD symptoms.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Hydroxyurea; Zileuton

Criteria

Inclusion Criteria:

• Admitted to the hospital for a COPD exacerbation

• FEV1 less than 60% of predicted level

• At least 10 pack years of smoking

Exclusion Criteria:

• Any uncontrolled systemic disease

• Known hypersensitivity to zileuton

• Asthma

• Lobar pneumonia or pulmonary edema

• Interstitial lung disease

• Medical condition that is likely to limit survival to less than 30 days at the time of study entry

• History of liver disease

• Current use of theophylline

• Participation in another clinical trial in the COPD Clinical Research Network

• Incarceration

• Institutionalization

• Pregnant

• History of a suicide attempt

• Prior inpatient admission for a psychiatric disorder

• Bipolar disorder

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