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Sponsors and Collaborators: |
National Heart, Lung, and Blood Institute (NHLBI) COPD Clinical Research Network |
Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00325754 |
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.
Condition | Intervention |
Pulmonary Disease, Chronic Obstructive |
Device: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder Device: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart |
MedlinePlus related topics: | COPD (Chronic Obstructive Pulmonary Disease) |
ChemIDplus related topics: | Aluminum |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Benefits of Ambulatory Oxygen in Hypoxemic COPD Patients |
Estimated Enrollment: | 100 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | June 2006 |
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 approximatley 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.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |||||
University of Alabama at Birmingham | |||||
Birmingham, Alabama, United States, 35249 | |||||
United States, California | |||||
University of California at San Francisco | |||||
San Francisco, California, United States, 94143 | |||||
Harbor-UCLA Research & Education Institution | |||||
Torrance, California, United States, 90502 | |||||
United States, Colorado | |||||
Denver City-County Health/Hospitals Department | |||||
Denver, Colorado, United States, 80262 | |||||
United States, Maryland | |||||
University of Maryland Baltimore | |||||
Baltimore, Maryland, United States, 21201 | |||||
United States, Massachusetts | |||||
Brigham and Women's Hospital | |||||
Boston, Massachusetts, United States, 02115 | |||||
United States, Michigan | |||||
University of Michigan | |||||
Ann Arbor, Michigan, United States, 48109 | |||||
United States, Minnesota | |||||
Minnesota Veterans Research Institute | |||||
Minneapolis, Minnesota, United States, 55440 | |||||
United States, Pennsylvania | |||||
Temple University | |||||
Philadelphia, Pennsylvania, United States, 19140 | |||||
University of Pittsburgh | |||||
Pittsburgh, Pennsylvania, United States, 15213 |
National Heart, Lung, and Blood Institute (NHLBI) |
COPD Clinical Research Network |
Principal Investigator: | 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 Research Institute |
Principal Investigator: | John J. Reilly | Brigham and Women's Hospital |
Principal Investigator: | Steven M. Scharf | University of Maryland |
Principal Investigator: | Frank Sciurba | University of Pittsburgh |
Study ID Numbers: | 396, U10 HL074424 |
First Received: | May 11, 2006 |
Last Updated: | October 20, 2006 |
ClinicalTrials.gov Identifier: | NCT00325754 |
Health Authority: | United States: Federal Government |
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