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

This study has been terminated.
(Lack of feasibility due to low recruitment)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00493974
First received: June 28, 2007
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Zileuton
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Antileukotriene Therapy for COPD Exacerbations

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Length of Hospital Stay [ Time Frame: Measured at Day 30 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in FEV1% Predicted [ Time Frame: Measured at Baseline and Day 30 ] [ Designated as safety issue: No ]
    Change in Post-bronchodilator FEV1% predicted comparing data at 30 day visit with baseline.

  • Change in FEV1/FEV6 Levels [ Time Frame: from baseline to day of discharge ] [ Designated as safety issue: No ]
    Change in Post-bronchodilator FEV1/FEV6 ratio comparing data at discharge visit with baseline.

  • Treatment Failure [ Time Frame: Baseline to day 30 visit ] [ Designated as safety issue: No ]
    Treatment failure is defined as death, intubation, readmission to a hospital for COPD, urgent visit to an outpatient or ED provider for symptoms of COPD or intensification of therapy [including second course of antibiotics for COPD, and second course of systemic steroids for COPD]) in the first 30 days after randomization.

  • Health-related Quality of Life [ Time Frame: Change from Baseline and 1 Month ] [ Designated as safety issue: No ]

    St. George's Respiratory Questionnaire - Total Score

    The SGRQ was asked with respect to the last one month as validated for acute exacerbations of COPD by Doll et al.

    Scale from 0 (no disability) to 100 (maximum disability).

    The SGRQ total score summarizes the impact of airway specific disease on overall health status. Scores range from zero (no impairment) to 100 (maximum impairment). Scores were calculated using the SGRQ scoring Algorithm.


  • Change in Urinary Leukotriene (LTE4) Levels [ Time Frame: Baseline and 24 hours ] [ Designated as safety issue: No ]
    Change in natural log-transformed LTE4 (ng/mg Cr.) from Baseline to 24 Hours

  • Change in Urinary Leukotriene (LTE4) Levels [ Time Frame: Baseline and 72 hours later ] [ Designated as safety issue: No ]
    Change in natural log-transformed LTE4 (ng/mg Cr.) from Baseline to 72 Hours


Enrollment: 119
Study Start Date: March 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Zileuton
Zileuton (Zyflo, 600 mg 4 times a day)
Drug: Zileuton
Zyflo tablets, 600 mg, 4 times a day
Other Name: Zyflo
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo 4 x daily
Other Name: Inactive Matching Placebo

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

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493974

Locations
United States, Alabama
University of Alabama Lung Health Center
Birmingham, Alabama, United States, 35249
Veteran's Administration Medical Center
Birmingham, Alabama, United States, 35294
United States, California
LA BioMed at Harbor, University of California
Los Angeles, California, United States, 90502
University of California San Francisco-Airway Clinical Research Center
San Francisco, California, United States, 94143
United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
Veteran's Administration Medical Center
Denver, Colorado, United States, 80220
United States, Maryland
University of Maryland Hospital
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Fallon Clinic
Boston, Massachusetts, United States, 01605
Veteran's Administration Medical Center
Boston, Massachusetts, United States, 02132
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
Veteran's Administration Medical Center
Ann Arbor, Michigan, United States, 48105
United States, Minnesota
Veteran's Administration Medical Center
Minneapolis, Minnesota, United States, 55417
HealthPartners Research Foundation
Minneapolis, Minnesota, United States, 55440
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Pennsylvania
Temple University Lung Center
Philadelphia, Pennsylvania, United States, 19140
University of Pittsburgh Emphysema Research Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Study Chair: Prescott Woodruff, MD University of California at San Francisco
  More Information

No publications provided by University of Minnesota - Clinical and Translational Science Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00493974     History of Changes
Other Study ID Numbers: 476, U10HL074424
Study First Received: June 28, 2007
Results First Received: December 18, 2009
Last Updated: April 12, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Chronic Obstructive Pulmonary Disease
COPD
Exacerbation
Anti-leukotriene
Length of Stay
LOS

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Zileuton
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Lipoxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014