Overview
Zileuton to Treat Adults With Chronic Obstructive Pulmonary Disease (The LEUKO Study)
Status:
Terminated
Terminated
Trial end date:
2008-12-01
2008-12-01
Target enrollment:
0
0
Participant gender:
All
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 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of MinnesotaUniversity of Minnesota - Clinical and Translational Science Institute
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)Treatments:
HydroxyureaZileuton
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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