Pulmonary Disease, Chronic ObstructivePhase 3LEUKONCT00493974
Zileuton to Treat Adults With Chronic Obstructive Pulmonary Disease (The LEUKO Study)
A Phase 3 study testing Zileuton in people with Pulmonary Disease, Chronic Obstructive, run by University of Minnesota at 18 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Zileuton
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 18 sitesUnited States
- Study dates
- Mar 2007to Dec 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to the hospital for a COPD exacerbation
- FEV1 less than 60% of predicted level
- At least 10 pack years of smoking
Who cannot join
- 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
Show all 16Show fewer
- 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
- '
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Veteran's Administration Medical Center
Ann Arbor, Michigan, 48105
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
University of Maryland Hospital
Baltimore, Maryland, 21201
University of Alabama Lung Health Center
Birmingham, Alabama, 35249
Veteran's Administration Medical Center
Birmingham, Alabama, 35294
Fallon Clinic
Boston, Massachusetts, 01605
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Veteran's Administration Medical Center
Boston, Massachusetts, 02132
Denver Health Medical Center
Denver, Colorado, 80204
National Jewish Medical and Research Center
Denver, Colorado, 80206
Veteran's Administration Medical Center
Denver, Colorado, 80220
LA BioMed at Harbor, University of California
Los Angeles, California, 90502
Veteran's Administration Medical Center
Minneapolis, Minnesota, 55417
HealthPartners Research Foundation
Minneapolis, Minnesota, 55440
Temple University Lung Center
Philadelphia, Pennsylvania, 19140
University of Pittsburgh Emphysema Research Center
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
University of California San Francisco-Airway Clinical Research Center
San Francisco, California, 94143
About this study
Official title: Antileukotriene Therapy for COPD Exacerbations
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.
Read the detailed 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Zileuton, Placebo
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Exacerbation, Anti-leukotriene, Length of Stay, LOS
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZileutonDrug
Also called Zyflo
Zyflo tablets, 600 mg, 4 times a day
PlaceboDrug
Also called Inactive Matching Placebo
Placebo 4 x daily
| Study group | Role | What they receive |
|---|---|---|
| Zileuton | Active comparator | Zileuton (Zyflo, 600 mg 4 times a day) Receives: Drug: Zileuton |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at Day 30
Secondary outcomes (6)
Change in FEV1% Predicted
Change in Post-bronchodilator FEV1% predicted comparing data at 30 day visit with baseline.
Measured: Measured at Baseline and Day 30
Change in FEV1/FEV6 Levels
Change in Post-bronchodilator FEV1/FEV6 ratio comparing data at discharge visit with baseline.
Measured: from baseline to day of discharge
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.
Measured: Baseline to day 30 visit
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.
Measured: Change from Baseline and 1 Month
Change in Urinary Leukotriene (LTE4) Levels
Change in natural log-transformed LTE4 (ng/mg Cr.) from Baseline to 24 Hours
Measured: Baseline and 24 hours
Change in Urinary Leukotriene (LTE4) Levels
Change in natural log-transformed LTE4 (ng/mg Cr.) from Baseline to 72 Hours
Measured: Baseline and 72 hours later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Lack of feasibility due to low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Prescott Woodruff, MD, Study chair, University of California at San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493974
- Sponsor's protocol ID
- 0701M00621
- Other IDs
- U10HL074424
- Acronym
- LEUKO
- Status last verified
- Oct 2019
- First submitted
- 28 Jun 2007
- Last updated
- 18 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Woodruff PG, Albert RK, Bailey WC, Casaburi R, Connett JE, Cooper JA Jr, Criner GJ, Curtis JL, Dransfield MT, Han MK, Harnden SM, Kim V, Marchetti N, Martinez FJ, McEvoy CE, Niewoehner DE, Reilly JJ, Rice K, Scanlon PD, Scharf SM, Sciurba FC, Washko GR, Lazarus SC; Copd Clinical Research Network. Randomized trial of zileuton for treatment of COPD exacerbations requiring hospitalization. COPD. 2011 Feb;8(1):21-9. doi: 10.3109/15412555.2010.540273.
PubMed 21299475
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antileukotriene Therapy for COPD Exacerbations
- ClinicalTrials.gov ID
- NCT00493974
- Acronym / sponsor ID
- LEUKO / 0701M00621
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Exacerbation, Anti-leukotriene, Length of Stay, LOS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of feasibility due to low recruitment
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 29 Jun 2007 (estimated)
- Results
- Posted 3 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zileuton | Active comparator | Drug: ZileutonZileuton (Zyflo, 600 mg 4 times a day) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admitted to the hospital for a COPD exacerbation
- FEV1 less than 60% of predicted level
- At least 10 pack years of smoking
Key exclusion criteria (16 listed)
- Any uncontrolled systemic disease
- Known hypersensitivity to zileuton
- Asthma
- Lobar pneumonia or pulmonary edema
- Interstitial lung disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZileutonAlso: ZyfloZyflo tablets, 600 mg, 4 times a day | Drug | Zileuton |
| PlaceboAlso: Inactive Matching PlaceboPlacebo 4 x daily | Drug | Placebo |
Primary outcome
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.
6 secondary outcomes
Change in FEV1% Predicted
Time frame: Measured at Baseline and Day 30
Change in FEV1/FEV6 Levels
Time frame: from baseline to day of discharge
Treatment Failure
Time frame: Baseline to day 30 visit
Health-related Quality of Life
Time frame: Change from Baseline and 1 Month
Change in Urinary Leukotriene (LTE4) Levels
Time frame: Baseline and 24 hours
Change in Urinary Leukotriene (LTE4) Levels
Time frame: Baseline and 72 hours later
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21299475Woodruff PG, Albert RK, Bailey WC, Casaburi R, Connett JE, Cooper JA Jr, Criner GJ, Curtis JL, Dransfield MT, Han MK, Harnden SM, Kim V, Marchetti N, Martinez FJ, McEvoy CE, Niewoehner DE, Reilly JJ, Rice K, Scanlon PD, Scharf SM, Sciurba FC, Washko GR, Lazarus SC; Copd Clinical Research Network. Randomized trial of zileuton for treatment of COPD exacerbations requiring hospitalization. COPD. 2011 Feb;8(1):21-9. doi: 10.3109/15412555.2010.540273.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prescott Woodruff, MD study chair
University of California at San Francisco
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zileuton in people with Pulmonary Disease, Chronic Obstructive, run by University of Minnesota at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Hospital Stay (time frame: Measured at Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00493974, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.