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| ID | Type | Description | Link |
|---|---|---|---|
| U10HL074424 | U.S. NIH Grant/Contract | View source |
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Lack of feasibility due to low recruitment
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zileuton | Active Comparator | Zileuton (Zyflo, 600 mg 4 times a day) |
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| Placebo | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zileuton | Drug | Zyflo tablets, 600 mg, 4 times a day |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 at Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FEV1% Predicted | Change in Post-bronchodilator FEV1% predicted comparing data at 30 day visit with baseline. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
'
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| Name | Affiliation | Role |
|---|---|---|
| Prescott Woodruff, MD | University of California at San Francisco | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Lung Health Center | Birmingham | Alabama | 35249 | United States | ||
| Veteran's Administration Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21299475 | Derived | 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. |
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Participants were screened using the eligibility criteria before randomization.
Participants were recruited from ER's and inpatient units from 10 main clinical sites (and their affiliated hospitals) between September 2007 and October 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Zileuton | Zileuton (Zyflo, 600 mg 4 times a day) |
| FG001 | Placebo | Matching placebo 4 times a day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Placebo 4 x daily |
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| 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. | 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. | 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 | Baseline and 24 hours |
| Change in Urinary Leukotriene (LTE4) Levels | Change in natural log-transformed LTE4 (ng/mg Cr.) from Baseline to 72 Hours | Baseline and 72 hours later |
| Birmingham |
| Alabama |
| 35294 |
| United States |
| LA BioMed at Harbor, University of California | Los Angeles | California | 90502 | United States |
| University of California San Francisco-Airway Clinical Research Center | San Francisco | California | 94143 | United States |
| Denver Health Medical Center | Denver | Colorado | 80204 | United States |
| National Jewish Medical and Research Center | Denver | Colorado | 80206 | United States |
| Veteran's Administration Medical Center | Denver | Colorado | 80220 | United States |
| University of Maryland Hospital | Baltimore | Maryland | 21201 | United States |
| Fallon Clinic | Boston | Massachusetts | 01605 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Veteran's Administration Medical Center | Boston | Massachusetts | 02132 | United States |
| Veteran's Administration Medical Center | Ann Arbor | Michigan | 48105 | United States |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109 | United States |
| Veteran's Administration Medical Center | Minneapolis | Minnesota | 55417 | United States |
| HealthPartners Research Foundation | Minneapolis | Minnesota | 55440 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Temple University Lung Center | Philadelphia | Pennsylvania | 19140 | United States |
| University of Pittsburgh Emphysema Research Center | Pittsburgh | Pennsylvania | 15213 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Zileuton | Zileuton (Zyflo, 600 mg 4 times a day) |
| BG001 | Placebo | Matching placebo 4 times a day |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | All applicable categories were checked for each participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Median | Standard Deviation | Days | Measured at Day 30 |
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| Secondary | Change in FEV1% Predicted | Change in Post-bronchodilator FEV1% predicted comparing data at 30 day visit with baseline. | 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. | Posted | Mean | Standard Error | percent predicted | Measured at Baseline and Day 30 |
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| Secondary | Change in FEV1/FEV6 Levels | Change in Post-bronchodilator FEV1/FEV6 ratio comparing data at discharge visit with baseline. | 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. | Posted | Mean | Standard Error | ratio | from baseline to day of discharge |
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| Secondary | 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. | Participants were analyzed following intention to treat (ITT) method. | Posted | Number | Participants | Baseline to day 30 visit |
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| Secondary | 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. | Participants were analyzed using the intent to treat method and included those that had SGRQ data at baseline and 1 month. | Posted | Mean | Standard Deviation | Units on a scale | Change from Baseline and 1 Month |
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| Secondary | Change in Urinary Leukotriene (LTE4) Levels | Change in natural log-transformed LTE4 (ng/mg Cr.) from Baseline to 24 Hours | Intent to Treat. Participants with urine sample at both visits. | Posted | Log Mean | Standard Error | (ng/mg Cr.) | Baseline and 24 hours |
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| Secondary | Change in Urinary Leukotriene (LTE4) Levels | Change in natural log-transformed LTE4 (ng/mg Cr.) from Baseline to 72 Hours | Intent to Treat. Participants with urine sample at both visits. | Posted | Log Mean | Standard Error | (ng/mg Cr.) | Baseline and 72 hours later |
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Participants were followed for adverse events from randomization to the 30 day follow-up visit. AEs that continued past the end of the study period were followed until the Investigator believed it reached a stable clinical endpoint or resolved.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zileuton | Zileuton (Zyflo, 600 mg 4 times a day) | 17 | 60 | 13 | 60 | ||
| EG001 | Placebo | Matching placebo 4 times a day | 20 | 59 | 12 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic Reaction( to amiodarone) | Immune system disorders | Systematic Assessment |
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| COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Chest Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | Systematic Assessment |
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| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
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| Depressive disorder | Psychiatric disorders | Systematic Assessment |
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| Heart Failure | Cardiac disorders | Systematic Assessment |
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| Lung Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| MRSA bursitis | Infections and infestations | Systematic Assessment |
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| Mycobacterium Avium Intracellular Complex | Infections and infestations | Systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Rectal bleeding | Gastrointestinal disorders | Systematic Assessment |
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| Renal Mass | Renal and urinary disorders | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Stroke | Vascular disorders | Systematic Assessment |
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| Urinary Tract Infection | Gastrointestinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| COPD worsening | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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Early termination leading to small numbers of subjects recruited
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Lindberg | University of Minnesota | 612-626-9011 | slindberg@umn.edu |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C063449 | zileuton |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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