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

Pulmonary Disease, Chronic Obstructive Clinical Trial

— LEUKO  

Official title:

Antileukotriene Therapy for COPD Exacerbations

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00493974
• Other study ID #: 0701M00621
• Secondary ID: U10HL074424
• Status: Terminated
• Phase: Phase 3
• Start date: March 2007
• Est. completion date: December 2008

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 119
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Zileuton
Zyflo tablets, 600 mg, 4 times a day
• Placebo
Placebo 4 x daily

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	Veteran's Administration Medical Center	Ann Arbor	Michigan
United States	University of Maryland Hospital	Baltimore	Maryland
United States	University of Alabama Lung Health Center	Birmingham	Alabama
United States	Veteran's Administration Medical Center	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Fallon Clinic	Boston	Massachusetts
United States	Veteran's Administration Medical Center	Boston	Massachusetts
United States	Denver Health Medical Center	Denver	Colorado
United States	National Jewish Medical and Research Center	Denver	Colorado
United States	Veteran's Administration Medical Center	Denver	Colorado
United States	LA BioMed at Harbor, University of California	Los Angeles	California
United States	HealthPartners Research Foundation	Minneapolis	Minnesota
United States	Veteran's Administration Medical Center	Minneapolis	Minnesota
United States	Temple University Lung Center	Philadelphia	Pennsylvania
United States	University of Pittsburgh Emphysema Research Center	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California San Francisco-Airway Clinical Research Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in FEV1% Predicted	Change in Post-bronchodilator FEV1% predicted comparing data at 30 day visit with baseline.	Measured at Baseline and Day 30
Secondary	Change in FEV1/FEV6 Levels	Change in Post-bronchodilator FEV1/FEV6 ratio comparing data at discharge visit with baseline.	from baseline to day of discharge
Secondary	Treatment Failure	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.	Baseline to day 30 visit
Secondary	Health-related Quality of Life	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 from Baseline and 1 Month
Secondary	Change in Urinary Leukotriene (LTE4) Levels	Change in natural log-transformed LTE4 (ng/mg Cr.) from Baseline to 24 Hours	Baseline and 24 hours
Secondary	Change in Urinary Leukotriene (LTE4) Levels	Change in natural log-transformed LTE4 (ng/mg Cr.) from Baseline to 72 Hours	Baseline and 72 hours later