Zileuton to Treat Adults With Chronic Obstructive Pulmonary Disease (The LEUKO Study) (LEUKO)
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|ClinicalTrials.gov Identifier: NCT00493974|
Recruitment Status : Terminated (Lack of feasibility due to low recruitment)
First Posted : June 29, 2007
Results First Posted : March 3, 2010
Last Update Posted : November 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive||Drug: Zileuton Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||119 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Antileukotriene Therapy for COPD Exacerbations|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
Active Comparator: Zileuton
Zileuton (Zyflo, 600 mg 4 times a day)
Zyflo tablets, 600 mg, 4 times a day
Other Name: Zyflo
Placebo Comparator: Placebo
Placebo 4 x daily
Other Name: Inactive Matching Placebo
- Length of Hospital Stay [ Time Frame: Measured at Day 30 ]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.
- Change in FEV1% Predicted [ Time Frame: Measured at Baseline and Day 30 ]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 ]Change in Post-bronchodilator FEV1/FEV6 ratio comparing data at discharge visit with baseline.
- Treatment Failure [ Time Frame: Baseline to day 30 visit ]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 ]
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 ]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 ]Change in natural log-transformed LTE4 (ng/mg Cr.) from Baseline to 72 Hours
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00493974
|Study Chair:||Prescott Woodruff, MD||University of California at San Francisco|