- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00325754
Benefits of Lightweight Ambulatory Oxygen Systems for Individuals With Chronic Obstructive Pulmonary Disease
October 30, 2019 updated by: University of Minnesota
Benefits of Ambulatory Oxygen in Hypoxemic COPD Patients
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35249
- University of Alabama at Birmingham
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California
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San Francisco, California, United States, 94143
- University of California at San Francisco
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Torrance, California, United States, 90502
- Harbor-UCLA Research & Education Institution
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Colorado
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Denver, Colorado, United States, 80262
- Denver City-County Health/Hospitals Department
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland Baltimore
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Minnesota
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Minneapolis, Minnesota, United States, 55440
- Minnesota Veterans Research Institute
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140
- Temple University
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: E-Cylinder
22-lb E-cylinder towed on a cart
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Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart
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Active Comparator: Lightweight Cylinder
3.6-lb lightweight cylinder that can be carried
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Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Stationary Oxygen Use Daily
Time Frame: 6 Months
|
6 Months
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Ambulatory/Portable Oxygen Use Daily
Time Frame: 6 months
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6 months
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Stationary Oxygen Use Daily
Time Frame: Baseline
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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3 Months
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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.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Frank Sciurba, University of Pittsburgh
- 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: 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, College Park
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Primary Completion (Actual)
June 1, 2006
Study Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
May 11, 2006
First Submitted That Met QC Criteria
May 11, 2006
First Posted (Estimate)
May 15, 2006
Study Record Updates
Last Update Posted (Actual)
November 18, 2019
Last Update Submitted That Met QC Criteria
October 30, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0405S60010
- U10HL074424 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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