NCT00493974: LEUKO

Antileukotriene Therapy for COPD Exacerbations

Terminated Phase 3 Results posted Last updated 30 October 2019

What this trial tests

Phase 3 trial testing Zileuton in Pulmonary Disease, Chronic Obstructive in 119 participants. Terminated before completion.

Timeline

1 March 2007

Primary endpoint
1 December 2008

1 December 2008

Quick facts

Lead sponsor	University of Minnesota
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	119
Start date	1 March 2007
Primary completion	1 December 2008
Estimated completion	1 December 2008
Sites	18 locations across United States

Drugs / interventions tested

• Zileuton — full drug profile →
• Placebo

Conditions studied

• Pulmonary Disease, Chronic Obstructive — all drugs for Pulmonary Disease, Chronic Obstructive →

Sponsor

University of Minnesota

Who can join

45 and older, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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 great

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Progress in the mechanism and targeted drug therapy for COPD.
   Wang C, Zhou J, Wang J, Li S, et al · · 2020 · cited 214× · PMID 33110061 · DOI 10.1038/s41392-020-00345-x
2. Emerging pharmaceutical therapies for COPD.
   Lakshmi SP, Reddy AT, Reddy RC. · · 2017 · cited 35× · PMID 28790817 · DOI 10.2147/copd.s121416
3. Randomized trial of zileuton for treatment of COPD exacerbations requiring hospitalization.
   Woodruff PG, Albert RK, Bailey WC, Casaburi R, et al · · 2011 · cited 29× · PMID 21299475 · DOI 10.3109/15412555.2010.540273
4. Inhaled RNA Therapeutics for Obstructive Airway Diseases: Recent Advances and Future Prospects.
   Xu Y, Thakur A, Zhang Y, Foged C. · · 2021 · cited 24× · PMID 33525500 · DOI 10.3390/pharmaceutics13020177
5. COPD Exacerbation Biomarkers Validated Using Multiple Reaction Monitoring Mass Spectrometry.
   Leung JM, Chen V, Hollander Z, Dai D, et al · · 2016 · cited 19× · PMID 27525416 · DOI 10.1371/journal.pone.0161129
6. Targeting neutrophils for cancer therapy.
   Kwak JW, Houghton AM. · · 2025 · cited 11× · PMID 40374764 · DOI 10.1038/s41573-025-01210-8
7. The Molecular Blueprint for Chronic Obstructive Pulmonary Disease (COPD): A New Paradigm for Diagnosis and Therapeutics.
   Shakeel I, Ashraf A, Afzal M, Sohal SS, et al · · 2023 · cited 10× · PMID 38155869 · DOI 10.1155/2023/2297559
8. High serum granulocyte-colony stimulating factor characterises neutrophilic COPD exacerbations associated with dysbiosis.
   Chakrabarti A, Mar JS, Choy DF, Cao Y, et al · · 2021 · cited 6× · PMID 34350278 · DOI 10.1183/23120541.00836-2020