Zileuton to Treat Adults With Chronic Obstructive Pulmonary Disease (The LEUKO Study)

NCT ID: NCT00493974

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2008-12-31

Brief 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.

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Zileuton

Zileuton (Zyflo, 600 mg 4 times a day)

Group Type: ACTIVE_COMPARATOR

Zileuton

Intervention Type: DRUG

Zyflo tablets, 600 mg, 4 times a day

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo 4 x daily

Interventions

Zileuton

Zyflo tablets, 600 mg, 4 times a day

Intervention Type: DRUG

Placebo

Placebo 4 x daily

Intervention Type: DRUG

Other Intervention Names

Zyflo; Inactive Matching Placebo

Eligibility 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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• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prescott Woodruff, MD

Role: STUDY_CHAIR

University of California at San Francisco

Locations

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

Countries

United States

References

Woodruff PG, Albert RK, Bailey WC, Casaburi R, Connett JE, Cooper JA Jr, Criner GJ, Curtis JL, Dransfield MT, Han MK, Harnden SM, Kim V, Marchetti N, Martinez FJ, McEvoy CE, Niewoehner DE, Reilly JJ, Rice K, Scanlon PD, Scharf SM, Sciurba FC, Washko GR, Lazarus SC; Copd Clinical Research Network. Randomized trial of zileuton for treatment of COPD exacerbations requiring hospitalization. COPD. 2011 Feb;8(1):21-9. doi: 10.3109/15412555.2010.540273.

Reference Type: DERIVED

PMID: 21299475 (View on PubMed)

Other Identifiers

U10HL074424

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0701M00621

Identifier Type: -

Identifier Source: org_study_id