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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% Predicted

Change 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

Page last updated: August 23, 2015

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