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NCT00493974 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by University of Minnesota.

Terminated
Registry status
Phase 3
Development phase
119
Enrollment target

NCT00493974: Clinical Trial Phase 3 study, sponsored by University of Minnesota.

NCT00493974 is a Phase 3 study that was terminated before completion, run by University of Minnesota. The registered enrollment target is 119 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00493974, a Phase 3 study, was terminated before completion, sponsored by University of Minnesota.

TERMINATED
Registry status
Phase 3
Development phase
119 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • DRUG Placebo
  • DRUG Zileuton

Trial Details

FieldValue
Enrollment Target 119 participants
Start Date 2007-03
Est. Completion 2008-12
Phase Phase 3
University of Minnesota

966 total trials

Why NCT00493974 stopped before completion

NCT00493974 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00493974 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00493974 about?

NCT00493974 is a clinical study titled "Zileuton to Treat Adults With Chronic Obstructive Pulmonary Disease (The LEUKO Study)". 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 ...

What is the current status of trial NCT00493974?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 119 participants. The study started on 2007-03. Estimated completion is 2008-12.

What interventions are being tested in trial NCT00493974?

The interventions under investigation include: Placebo (DRUG), Zileuton (DRUG).

Who is sponsoring clinical trial NCT00493974?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00493974's enrollment target sits among peer trials

119 1640th of 2000 higher than 360 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00493974, the US trial registry maintained by the National Library of Medicine. NCT00493974 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.