Study Stopped
Lack of feasibility due to low recruitment
Zileuton to Treat Adults With Chronic Obstructive Pulmonary Disease (The LEUKO Study)
LEUKO
Antileukotriene Therapy for COPD Exacerbations
2 other identifiers
interventional
119
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2007
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 28, 2007
CompletedFirst Posted
Study publicly available on registry
June 29, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
March 3, 2010
CompletedNovember 18, 2019
October 1, 2019
1.8 years
June 28, 2007
December 18, 2009
October 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Length of Hospital Stay
Admission will begin at the time the subject has been admitted to an inpatient service. Length of Stay (LOS) will be recorded in days. The LOS will be based on the number of days spent in an acute medical ward or in the ICU. Subjects that are admitted and discharged in the same 24 hour period will be recorded as a LOS of 1 day, as will subjects discharged in the ensuing 24 hour period. LOS's greater than 10 days will be truncated to 10 days.
Measured at Day 30
Secondary Outcomes (6)
Change in FEV1% Predicted
Measured at Baseline and Day 30
Change in FEV1/FEV6 Levels
from baseline to day of discharge
Treatment Failure
Baseline to day 30 visit
Health-related Quality of Life
Change from Baseline and 1 Month
Change in Urinary Leukotriene (LTE4) Levels
Baseline and 24 hours
- +1 more secondary outcomes
Study Arms (2)
Zileuton
ACTIVE COMPARATORZileuton (Zyflo, 600 mg 4 times a day)
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Admitted to the hospital for a COPD exacerbation
- FEV1 less than 60% of predicted level
- At least 10 pack years of smoking
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
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
Fallon Clinic
Boston, Massachusetts, 01605, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Veteran's Administration Medical Center
Boston, Massachusetts, 02132, United States
Veteran's Administration Medical Center
Ann Arbor, Michigan, 48105, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
Veteran's Administration Medical Center
Minneapolis, Minnesota, 55417, United States
HealthPartners Research Foundation
Minneapolis, Minnesota, 55440, 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
Related Publications (1)
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.
PMID: 21299475DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Early termination leading to small numbers of subjects recruited
Results Point of Contact
- Title
- Sarah Lindberg
- Organization
- University of Minnesota
Study Officials
- STUDY CHAIR
Prescott Woodruff, MD
University of California at San Francisco
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2007
First Posted
June 29, 2007
Study Start
March 1, 2007
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
November 18, 2019
Results First Posted
March 3, 2010
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share