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

Antileukotriene Therapy for COPD Exacerbations

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.

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.

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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