Zileuton to Treat Adults With Chronic Obstructive Pulmonary Disease (The LEUKO Study)
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Pulmonary Disease, Chronic Obstructive
In brief
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.
Key facts
- Study ID
- NCT00493974
- Run by
- University of Minnesota
- People needed
- 119
- Starts
- 2007-03-01
- Expected to finish
- 2008-12-01
- Last updated by the study team
- 2019-11-18
Who can join
Age: 45 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Admitted to the hospital for a COPD exacerbation
- FEV1 less than 60% of predicted level
- At least 10 pack years of smoking
You may not qualify if…
- 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
Where it is running
- University of Alabama Lung Health Center — Birmingham, Alabama, United States
- Veteran's Administration Medical Center — Birmingham, Alabama, United States
- LA BioMed at Harbor, University of California — Los Angeles, California, United States
- University of California San Francisco-Airway Clinical Research Center — San Francisco, California, United States
- Denver Health Medical Center — Denver, Colorado, United States
- National Jewish Medical and Research Center — Denver, Colorado, United States
- Veteran's Administration Medical Center — Denver, Colorado, United States
- University of Maryland Hospital — Baltimore, Maryland, United States
- Fallon Clinic — Boston, Massachusetts, United States
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- Veteran's Administration Medical Center — Boston, Massachusetts, United States
- Veteran's Administration Medical Center — Ann Arbor, Michigan, United States
- University of Michigan Medical Center — Ann Arbor, Michigan, United States
- Veteran's Administration Medical Center — Minneapolis, Minnesota, United States
- HealthPartners Research Foundation — Minneapolis, Minnesota, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Temple University Lung Center — Philadelphia, Pennsylvania, United States
- University of Pittsburgh Emphysema Research Center — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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