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

University of Minnesota (UMN)

Status and phase

Terminated

Phase 3

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Drug: Placebo

Drug: Zileuton

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00493974

0701M00621

U10HL074424 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

119 patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

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