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

This study is ongoing, but not recruiting participants.

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
  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)   

ChemIDplus related topics:   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
Estimated Study Completion Date:   June 2006

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)
COPD 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
First Received:   May 11, 2006
Last Updated:   October 20, 2006
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
Chronic Disease
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 03, 2008




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