Benefits of Lightweight Ambulatory Oxygen Systems for Individuals With Chronic Obstructive Pulmonary Disease (COPD) Who Need Supplemental Oxygen - Full Text View

Sponsors and Collaborators:	National Heart, Lung, and Blood Institute (NHLBI) Chronic Obstructive Pulmonary Disease Clinical Research Network
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00325754

Purpose

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)

Drug Information available for: Aluminum

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Benefits of Ambulatory Oxygen in Hypoxemic COPD Patients

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

Measured at Month 6: total number of hours of stationary oxygen use
total number of hours of ambulatory/portable oxygen use

Secondary Outcome Measures:

Measured at Months 3 and 5: activity
Measured at Months 3 and 6: spirometric lung function testing
hemoglobin level
functional exercise capacity
body weight
health status
ambulatory status
survival
number of exacerbations, physician office visits, and hospitalizations
exercise endurance (measured at selected sites)

Estimated Enrollment:	100
Study Start Date:	March 2005
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Currently in a stable phase of COPD, defined as having had no disease exacerbation within the 4 weeks prior to study entry
Ambulatory
Forced expiratory volume in one second (FEV1) less than or equal to 60% of predicted value at screening
Ratio of FEV1 and forced vital capacity (FEV1/FVC) less than or equal to 65% of predicted value at screening
Currently receiving LTOT
Partial pressure of oxygen in arterial blood (PaO2) less than 60 torr

Exclusion Criteria:

Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, left-sided heart failure, peripheral vascular disease, exertional angina, complex arrhythmias, severe dependent edema, ischemic changes on stress electrocardiogram that would be contraindications for unrestricted ambulation or the 6-minute walk test)
Orthopedic impairments that would limit ambulation
Participation in the active phase of pulmonary rehabilitation within the 3 months prior to study entry
Neurologic impairments (e.g., Parkinson's disease or a stroke) or mental states (e.g., senile dementia) that would limit independent ambulation
Neoplastic disease that is anticipated to influence survival
Currently receiving lightweight ambulatory oxygen therapy
Inability to maintain an oxygen saturation of 92% at rest with 4L/minute of continuous oxygen flow and during exercise with an oxygen conserver setting of 6 utilizing a nasal cannula
Currently a smoker
Sleep apnea if it is characterized primarily as central sleep apnea syndrome (whether being treated or not) OR if it is known or suspected obstructive sleep apnea that has existed for at least 2 months and has not received stable treatment (stable treatment modes include positive airway pressure therapies or dental orthotic/mandibular positioning devices); individuals with diagnosed obstructive sleep apnea must have a body mass index less than or equal to 30 kg/m2 to be eligible for this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325754

Locations

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

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Chronic Obstructive Pulmonary Disease Clinical Research Network

Investigators

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

More Information

Study ID Numbers:	396, U10 HL074424
Study First Received:	May 11, 2006
Last Updated:	October 7, 2008
ClinicalTrials.gov Identifier:	NCT00325754
Health Authority:	United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):

Chronic Obstructive Pulmonary Disease
COPD

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Respiration Disorders
Chronic Disease
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009