| ID | Type | Description | Link |
|---|---|---|---|
| U10HL074424 | U.S. NIH Grant/Contract | View source |
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low recruitment
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Chronic Obstructive Pulmonary Disease Clinical Research Network | NETWORK |
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Chronic Obstructive Pulmonary Disease (COPD) affects over 14 million people in the United States. It is the fourth leading cause of death and the only leading cause of death for which mortality rates are rising. Medical science has developed few effective therapies for COPD. In patients with advanced COPD and chronic hypoxemia, long-term oxygen therapy (LTOT) has been shown to be uniquely beneficial. It is the only available non-surgical therapy demonstrated to prolong survival in these patients. This study will compare the clinical and physiologic benefits of two different oxygen therapy devices among hypoxemic individuals with COPD: a lightweight ambulatory oxygen device versus the standard portable E-cylinder device.
Individuals with COPD who experience hypoxemia (reduction of oxygen concentration in arterial blood) have an especially poor prognosis. Provision of LTOT to hypoxemic COPD patients is considered to be the standard of care. The majority of hypoxemic patients that are ambulatory are supplied with pressurized oxygen in E-cylinders. This system weighs approximately 22 pounds, is mounted on a wheeled cart, and is towed by the patient. These cumbersome systems can be seen to impose a significant burden on weak and debilitated patients, discouraging them from being active. E-cylinders towed on a cart are referred to as 'portable', in contrast to lightweight 'ambulatory' oxygen systems, which weigh less than 10 pounds and are designed to be carried by the patient. It is unknown whether patients provided with lightweight ambulatory systems comply better with oxygen prescription and increase their daily level of activity. This study will compare the use and benefits of a lightweight ambulatory oxygen device versus the standard portable E-cylinder device among hypoxemic individuals with COPD. Specifically, the study will examine daily duration of oxygen therapy and activity levels amongst both groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E-Cylinder | Active Comparator | 22-lb E-cylinder towed on a cart |
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| Lightweight Cylinder | Active Comparator | 3.6-lb lightweight cylinder that can be carried |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-Cylinder | Device | Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stationary Oxygen Use Daily | 6 Months | |
| Ambulatory/Portable Oxygen Use Daily | 6 months | |
| Stationary Oxygen Use Daily | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Average Mid-day Activity Monitoring at 3 Months | Physical activity was monitored for 3 weeks before the 3-month visit using tri-axial accelerometers worn on a waist belt. Activity is expressed in vector magnitude units (VMU, the vectorial sum of activity counts in three orthogonal directions) per minute. Mid-day defined as 10AM-4PM. | 3 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard K. Albert | Denver City-County Health/Hospitals Department | Principal Investigator |
| William Bailey | University of Alabama at Birmingham | Principal Investigator |
| Richard Casaburi | Harbor-UCLA Research & Education Institution | Principal Investigator |
| John Connett | University of Minnesota | Principal Investigator |
| Gerard J. Criner | Temple University | Principal Investigator |
| Stephen C. Lazarus | Univeristy of California at San Francisco | Principal Investigator |
| Fernando J. Martinez | University of Michigan | Principal Investigator |
| Dennis E. Niewoehner | Minnesota Veterans Medical Research and Education Foundation | Principal Investigator |
| John J. Reilly | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States | ||
| University of California at San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19378225 | Result | Hecht A, Ma S, Porszasz J, Casaburi R; COPD Clinical Research Network. Methodology for using long-term accelerometry monitoring to describe daily activity patterns in COPD. COPD. 2009 Apr;6(2):121-9. doi: 10.1080/15412550902755044. | |
| 22292592 | Result | Casaburi R, Porszasz J, Hecht A, Tiep B, Albert RK, Anthonisen NR, Bailey WC, Connett JE, Cooper JA Jr, Criner GJ, Curtis J, Dransfield M, Lazarus SC, Make B, Martinez FJ, McEvoy C, Niewoehner DE, Reilly JJ, Scanlon P, Scharf SM, Sciurba FC, Woodruff P; COPD Clinical Research Network. Influence of lightweight ambulatory oxygen on oxygen use and activity patterns of COPD patients receiving long-term oxygen therapy. COPD. 2012 Feb;9(1):3-11. doi: 10.3109/15412555.2011.630048. |
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| ID | Title | Description |
|---|---|---|
| FG000 | E-Cylinder | 22-lb E-cylinder towed on a cart E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart |
| FG001 | Lightweight Cylinder | 3.6-lb lightweight cylinder that can be carried Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Lightweight Cylinder | Device | Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder |
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| Mid-day Activity Monitoring at 6 Months | Physical activity was monitored for 3 weeks before the 6-month visit using tri-axial accelerometers worn on a waist belt. Activity is expressed in vector magnitude units (VMU, the vectorial sum of activity counts in three orthogonal directions) per minute. Mid-day defined as 10AM-4PM.). Mid-day defined as 10AM-4PM. | 6 months |
| Steven M. Scharf |
| University of Maryland, College Park |
| Principal Investigator |
| Frank Sciurba | University of Pittsburgh | Principal Investigator |
| San Francisco |
| California |
| 94143 |
| United States |
| Harbor-UCLA Research & Education Institution | Torrance | California | 90502 | United States |
| Denver City-County Health/Hospitals Department | Denver | Colorado | 80262 | United States |
| University of Maryland Baltimore | Baltimore | Maryland | 21201 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Minnesota Veterans Research Institute | Minneapolis | Minnesota | 55440 | United States |
| Temple University | Philadelphia | Pennsylvania | 19140 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| 22077070 | Derived | Kunisaki KM, Niewoehner DE, Connett JE; COPD Clinical Research Network. Vitamin D levels and risk of acute exacerbations of chronic obstructive pulmonary disease: a prospective cohort study. Am J Respir Crit Care Med. 2012 Feb 1;185(3):286-90. doi: 10.1164/rccm.201109-1644OC. Epub 2011 Nov 10. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | E-Cylinder | 22-lb E-cylinder towed on a cart E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart |
| BG001 | Lightweight Cylinder | 3.6-lb lightweight cylinder that can be carried Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder |
| 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) | Count of Participants | Participants |
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| Cigarette Pack Years | Mean | Standard Deviation | pack-years |
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| Forced expiratory volume in 1 second (FEV1) % Predicted | Mean | Standard Deviation | Percent predicted |
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| Partial pressure of O2 (PaO2) | Mean | Standard Deviation | torr |
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| Partial pressure of carbon dioxide (PaCO2) | Mean | Standard Deviation | torr |
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| Negative logarithm of hydrogen Ion concentration in arterial blood (pHa) | Mean | Standard Deviation | pH units |
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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 | Stationary Oxygen Use Daily | Posted | Mean | Standard Deviation | Hours | 6 Months |
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| Primary | Ambulatory/Portable Oxygen Use Daily | Posted | Mean | Standard Deviation | Hours | 6 months |
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| Primary | Stationary Oxygen Use Daily | Posted | Mean | Standard Deviation | Hours | Baseline |
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| Secondary | Average Mid-day Activity Monitoring at 3 Months | Physical activity was monitored for 3 weeks before the 3-month visit using tri-axial accelerometers worn on a waist belt. Activity is expressed in vector magnitude units (VMU, the vectorial sum of activity counts in three orthogonal directions) per minute. Mid-day defined as 10AM-4PM. | Posted | Mean | Standard Deviation | Vector magnitude units (VMU)/min | 3 Months |
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| Secondary | Mid-day Activity Monitoring at 6 Months | Physical activity was monitored for 3 weeks before the 6-month visit using tri-axial accelerometers worn on a waist belt. Activity is expressed in vector magnitude units (VMU, the vectorial sum of activity counts in three orthogonal directions) per minute. Mid-day defined as 10AM-4PM.). Mid-day defined as 10AM-4PM. | Posted | Mean | Standard Deviation | Vector magnitude units (VMU)/min | 6 months |
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6 months
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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 | E-Cylinder | 22-lb E-cylinder towed on a cart E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart | 5 | 11 | 8 | 11 | ||
| EG001 | Lightweight Cylinder | 3.6-lb lightweight cylinder that can be carried Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder | 4 | 11 | 8 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angioedema | Endocrine disorders | ICD9 | Systematic Assessment |
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| Confusion | Psychiatric disorders | ICD9 | Systematic Assessment |
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| COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | ICD9 | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | ICD9 | Systematic Assessment |
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| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | ICD9 | Systematic Assessment |
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| Inguinal Hernia | Gastrointestinal disorders | ICD9 | Systematic Assessment |
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| Chest Pain | General disorders | ICD9 | Systematic Assessment |
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| Shortness of Breath | General disorders | ICD9 | Systematic Assessment |
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| Sudden Death | General disorders | ICD9 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Respiratory Infection | Respiratory, thoracic and mediastinal disorders | ICD9 | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | ICD9 | Systematic Assessment |
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| Influenza | Respiratory, thoracic and mediastinal disorders | ICD9 | Systematic Assessment |
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| Bronchitis | Respiratory, thoracic and mediastinal disorders | ICD9 | Systematic Assessment |
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| COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | ICD9 | Systematic Assessment |
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| Other COPD | Respiratory, thoracic and mediastinal disorders | ICD-9 | Systematic Assessment |
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| Other Respiratory | Respiratory, thoracic and mediastinal disorders | ICD9 | Systematic Assessment |
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| Abdominal Hernia | Gastrointestinal disorders | ICD9 | Systematic Assessment |
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| Elevated Blood Urea Nitrogen (BUN) | Renal and urinary disorders | ICD9 | Systematic Assessment |
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| Cystitis | Renal and urinary disorders | ICD9 | Systematic Assessment |
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| Urinary Infection | Renal and urinary disorders | ICD9 | Systematic Assessment |
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| Joint Pain | Musculoskeletal and connective tissue disorders | ICD9 | Systematic Assessment |
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| Epistaxis | General disorders | ICD9 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | ICD9 | Systematic Assessment |
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| Chest Pain | Cardiac disorders | ICD9 | Systematic Assessment |
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| Sprain | Musculoskeletal and connective tissue disorders | ICD9 | Systematic Assessment |
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| Confusion | Psychiatric disorders | ICD9 | Systematic Assessment |
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The Data Safety and Monitoring Board requested termination of this study due to low recruitment. 22 participants were randomized out of a goal of 100.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Casaburi | Harbo-UCLA Research and Education Institute | 310-22-8249 | casaburi@ucla.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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| 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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