Zileuton to Treat Adults With Chronic Obstructive Pulmonary Disease (The LEUKO Study)
Information source: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Disease, Chronic Obstructive
Intervention: Zileuton (Drug); Placebo (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: University of Minnesota - Clinical and Translational Science Institute Official(s) and/or principal investigator(s): Prescott Woodruff, MD, Study Chair, Affiliation: University of California at San Francisco
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.
Clinical Details
Official title: Antileukotriene Therapy for COPD Exacerbations
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Length of Hospital Stay
Secondary outcome: Change in FEV1% PredictedChange in FEV1/FEV6 Levels Treatment Failure Health-related Quality of Life Change in Urinary Leukotriene (LTE4) Levels Change in Urinary Leukotriene (LTE4) Levels
Detailed description:
COPD is a disease in which the lung airways are partly damaged and obstructed, making it
difficult to breathe. COPD is the fourth leading cause of death in the United States.
Symptoms include coughing, excess mucus production, shortness of breath, wheezing, and chest
tightness. Treatment usually includes inhaled bronchodilator or steroid medications that
work by relaxing the muscles around the lung airways and reducing inflammation. Zileuton, a
medication that is used to prevent asthma symptoms, may be beneficial in treating people who
experience COPD exacerbations. Zileuton works by blocking the formation of substances that
cause inflammation, fluid retention, and constriction in the lungs. The purpose of this
study is to evaluate the effectiveness of zileuton at reducing the length of a hospital stay
for adults who are hospitalized for a COPD exacerbation.
This study will enroll adults who are admitted to the hospital due to severe COPD symptoms.
Participants will be randomly assigned to receive either zileuton or placebo four times a
day for up to 14 days. While in the hospital, lung function testing and urine collection
will occur. Study visits will occur at Days 14 and 30, and will include lung function
testing, a medical history review, and a study drug adverse effects review.
Eligibility
Minimum age: 45 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
University of Alabama Lung Health Center, Birmingham, Alabama 35249, United States
Veteran's Administration Medical Center, Birmingham, Alabama 35294, United States
LA BioMed at Harbor, University of California, Los Angeles, California 90502, United States
University of California San Francisco-Airway Clinical Research Center, San Francisco, California 94143, United States
Denver Health Medical Center, Denver, Colorado 80204, United States
National Jewish Medical and Research Center, Denver, Colorado 80206, United States
Veteran's Administration Medical Center, Denver, Colorado 80220, United States
University of Maryland Hospital, Baltimore, Maryland 21201, United States
Brigham and Women's Hospital, Boston, Massachusetts 02115, United States
Fallon Clinic, Boston, Massachusetts 01605, United States
Veteran's Administration Medical Center, Boston, Massachusetts 02132, United States
University of Michigan Medical Center, Ann Arbor, Michigan 48109, United States
Veteran's Administration Medical Center, Ann Arbor, Michigan 48105, United States
HealthPartners Research Foundation, Minneapolis, Minnesota 55440, United States
Veteran's Administration Medical Center, Minneapolis, Minnesota 55417, United States
Mayo Clinic, Rochester, Minnesota 55905, United States
Temple University Lung Center, Philadelphia, Pennsylvania 19140, United States
University of Pittsburgh Emphysema Research Center, Pittsburgh, Pennsylvania 15213, United States
Additional Information
Starting date: March 2007
Last updated: April 12, 2013
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