Clinical trial NCT00493974: Zileuton to Treat Adults With Chronic Obstructive Pulmonary Disease (The LEUKO Study)
Official title: Antileukotriene Therapy for COPD Exacerbations
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease
COPD
Exacerbation
Anti-leukotriene
Length of Stay
LOS
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2007-06-29
Enrollment: 119
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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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Primary outcomes:
measure: Length of Hospital Stay
timeFrame: Measured at Day 30
Secondary outcomes:
measure: Change in FEV1% Predicted
timeFrame: Measured at Baseline and Day 30
measure: Change in FEV1/FEV6 Levels
timeFrame: from baseline to day of discharge
measure: Treatment Failure
timeFrame: Baseline to day 30 visit
measure: Health-related Quality of Life
timeFrame: Change from Baseline and 1 Month
measure: Change in Urinary Leukotriene (LTE4) Levels
timeFrame: Baseline and 24 hours
measure: Change in Urinary Leukotriene (LTE4) Levels
timeFrame: Baseline and 72 hours later
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Lung Health Center
state: Alabama
city: Birmingham
country: United States
facility: Veteran's Administration Medical Center
state: Alabama
city: Los Angeles
country: United States
facility: LA BioMed at Harbor, University of California
state: California
city: San Francisco
country: United States
facility: University of California San Francisco-Airway Clinical Research Center
state: California
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: Denver
country: United States
facility: National Jewish Medical and Research Center
state: Colorado
city: Denver
country: United States
facility: Veteran's Administration Medical Center
state: Colorado
city: Baltimore
country: United States
facility: University of Maryland Hospital
state: Maryland
city: Boston
country: United States
facility: Fallon Clinic
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Veteran's Administration Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: Veteran's Administration Medical Center
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Minneapolis
country: United States
facility: Veteran's Administration Medical Center
state: Minnesota
city: Minneapolis
country: United States
facility: HealthPartners Research Foundation
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Philadelphia
country: United States
facility: Temple University Lung Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Emphysema Research Center
state: Pennsylvania
Study officials:
affiliation: University of California at San Francisco
name: Prescott Woodruff, MD
role: STUDY_CHAIR
References:
citation: 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.