Trial · NCT00493974

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

NCT00493974, Phase 3, Terminated, University of Minnesota; results first posted 2010-03-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Zileuton to Treat Adults With Chronic Obstructive Pulmonary Disease (The LEUKO Study). Trials, record NCT00493974. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00493974

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Zileuton to Treat Adults With Chronic Obstructive Pulmonary Disease (The LEUKO Study)
NCT number: NCT00493974
Status: Terminated
Phases: Phase 3
Enrollment: 119 participants, actual
Lead sponsor: University of Minnesota
Conditions: Pulmonary Disease, Chronic Obstructive
Interventions: Zileuton, Placebo
First posted: 2007-06-29
Last updated: 2019-11-18
Results first posted: 2010-03-03
Limitations and caveats: Early termination leading to small numbers of subjects recruited

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

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

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Length of Hospital Stay	Measured at Day 30	Participants were analyzed following intention to treat (ITT) method.~One participant randomized to Zileuton withdrew consent before hospital discharge.~Days to discharge are set at a maximum of 10 days.	Days	MEDIAN
SECONDARY	Change in FEV1% Predicted	Measured at Baseline and Day 30	Participants were analyzed using the intent to treat method. The N is lower than total randomized due to participants that were unable to perform spirometry at baseline.	percent predicted	MEAN
SECONDARY	Change in FEV1/FEV6 Levels	from baseline to day of discharge	Participants were analyzed using the intent to treat method. The N is lower than total randomized due to participants that were unable to perform spirometry at baseline and missing discharge data.	ratio	MEAN
SECONDARY	Treatment Failure	Baseline to day 30 visit	Participants were analyzed following intention to treat (ITT) method.	Participants	NUMBER
SECONDARY	Health-related Quality of Life	Change from Baseline and 1 Month	Participants were analyzed using the intent to treat method and included those that had SGRQ data at baseline and 1 month.	Units on a scale	MEAN
SECONDARY	Change in Urinary Leukotriene (LTE4) Levels	Baseline and 24 hours	Intent to Treat.~Participants with urine sample at both visits.	(ng/mg Cr.)	LOG_MEAN
SECONDARY	Change in Urinary Leukotriene (LTE4) Levels	Baseline and 72 hours later	Intent to Treat.~Participants with urine sample at both visits.	(ng/mg Cr.)	LOG_MEAN

Source ClinicalTrials.gov

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Length of Hospital Stay	Zileuton		3	Standard Deviation 2.19	Days
Length of Hospital Stay	Placebo		3	Standard Deviation 3.06	Days
Change in FEV1% Predicted	Zileuton		6.8	Standard Error 4.2	percent predicted
Change in FEV1% Predicted	Placebo		8.0	Standard Error 4.4	percent predicted
Change in FEV1/FEV6 Levels	Zileuton		0.02	Standard Error 0.03	ratio
Change in FEV1/FEV6 Levels	Placebo		0.03	Standard Error 0.02	ratio
Treatment Failure	Zileuton	Death	1		Participants
Treatment Failure	Placebo	Death	2		Participants
Treatment Failure	Zileuton	Intubation	1		Participants
Treatment Failure	Placebo	Intubation	1		Participants

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Zileuton	60
Overall Study	STARTED	Placebo	59
Overall Study	COMPLETED	Zileuton	47
Overall Study	COMPLETED	Placebo	45
Overall Study	NOT COMPLETED	Zileuton	13
Overall Study	NOT COMPLETED	Placebo	14

Source ClinicalTrials.gov

Adverse events40

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Dyspnea	Respiratory, thoracic and mediastinal disorders	Zileuton	9	60	19
other	Dyspnea	Respiratory, thoracic and mediastinal disorders	Placebo	6	59	14
other	COPD worsening	Respiratory, thoracic and mediastinal disorders	Zileuton	4	60	4
other	COPD worsening	Respiratory, thoracic and mediastinal disorders	Placebo	6	59	6
serious	Allergic Reaction( to amiodarone)	Immune system disorders	Zileuton	1	60	1
serious	Allergic Reaction( to amiodarone)	Immune system disorders	Placebo	0	59	0
serious	COPD Exacerbation	Respiratory, thoracic and mediastinal disorders	Zileuton	8	60	8
serious	COPD Exacerbation	Respiratory, thoracic and mediastinal disorders	Placebo	10	59	10
serious	Cellulitis	Skin and subcutaneous tissue disorders	Zileuton	0	60	0
serious	Cellulitis	Skin and subcutaneous tissue disorders	Placebo	1	59	1

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Zileuton
Total, all-cause mortality	Placebo
Total, other adverse events	Zileuton	13	60
Total, other adverse events	Placebo	12	59
Total, serious adverse events	Zileuton	17	60
Total, serious adverse events	Placebo	20	59

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21299475	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10HL074424	COPD Clinical Research Network - Data Coordinating Center	CONNETT, JOHN E	UNIVERSITY OF MINNESOTA	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2003 to 2011

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Zileuton vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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