Overview

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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