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Benefits of Lightweight Ambulatory Oxygen Systems for Individuals With Chronic Obstructive Pulmonary Disease

This study has been terminated.
(low recruitment)
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Chronic Obstructive Pulmonary Disease Clinical Research Network
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00325754
First received: May 11, 2006
Last updated: October 17, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention
Pulmonary Disease, Chronic Obstructive
Device: E-Cylinder
Device: Lightweight Cylinder

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Benefits of Ambulatory Oxygen in Hypoxemic COPD Patients

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Stationary Oxygen Use Daily [ Time Frame: 6 Months ]
  • Ambulatory/Portable Oxygen Use Daily [ Time Frame: 6 months ]
  • Stationary Oxygen Use Daily [ Time Frame: Baseline ]

Secondary Outcome Measures:
  • Average Mid-day Activity Monitoring at 3 Months [ Time Frame: 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.

  • Mid-day Activity Monitoring at 6 Months [ Time Frame: 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.


Enrollment: 22
Study Start Date: March 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: E-Cylinder
22-lb E-cylinder towed on a cart
Device: E-Cylinder
Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart
Active Comparator: Lightweight Cylinder
3.6-lb lightweight cylinder that can be carried
Device: Lightweight Cylinder
Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder

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 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.
  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 long-term oxygen therapy (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 4 liter/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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of Minnesota - Clinical and Translational Science Institute
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, MN
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: Steven M. Scharf University of Maryland
Principal Investigator: Frank Sciurba University of Pittsburgh
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00325754     History of Changes
Obsolete Identifiers: NCT00119860
Other Study ID Numbers: 396
U10HL074424 ( US NIH Grant/Contract Award Number )
Study First Received: May 11, 2006
Results First Received: May 20, 2016
Last Updated: October 17, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Chronic Obstructive Pulmonary Disease
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2017