Portable Oxygen Concentrator Improvements to Physical Activity, Oxygen Usage, and Quality of Life in Chronic Obstructive Pulmonary Disease Patients Using Long-term Oxygen Therapy (POC-STEP)



Status:Recruiting
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:3/30/2019
Start Date:July 24, 2018
End Date:February 28, 2021
Contact:Maureen E Crocker
Email:maureen.crocker@resmed.com
Phone:8588366653

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To evaluate changes in activity based on the use of portable oxygen concentrators combined
with standard of care (SOC) long- term oxygen therapy versus SOC long-term oxygen therapy
alone at 12 weeks in patients with COPD who require continuous (24/7) long-term oxygen
therapy. The study will also assess oxygen usage, quality of life, hospitalizations and
death.


Inclusion Criteria:

1. Patient is 40 years or older.

2. Patient has a documented diagnosis of COPD.

3. Patient qualifies for continuous (24/7) long-term oxygen therapy.

4. Patient is prescribed oxygen at ≤ 5 L/min.

5. Patient is POC-naïve, i.e., has not used a POC prior to enrolling in this study.

6. Patient is able to tolerate pulsed oxygen therapy, i.e., oxygen delivered via a POC.

7. Patient is able to fully understand study information and provide signed informed
consent and HIPAA authorization.

Exclusion Criteria:

1. Patient's condition is contraindicated for the use of a POC.

2. Patient has uncontrolled or untreated sleep-disordered breathing that is uncontrolled
or untreated.

3. Patient is unable to complete the 6-minute walk test.

4. Patient has a diagnosis (within less than two weeks prior to study entry) of pneumonia
or respiratory infection, and/or acute bronchitis requiring antibiotics, or
new/increased dose of systemic corticosteroids.

5. Patient has had thoracic surgery or another procedure in the six months prior to
enrollment that is likely to cause instability of pulmonary status.

6. Patient has an open skin ulcer or rash where the activity monitor will be worn on the
body.

7. Patient has a life expectancy < 1 year.

8. Patient has non-COPD lung disease that may affect oxygenation or survival.

9. Patient has a planned intervention(s) requiring hospitalization within the three
months of study participation.

10. Patient is pregnant or planning to become pregnant.

11. Patient is participating in a clinical study of a medical product and has not
completed the required follow-up period.

12. Patient, in the opinion of the investigator, should be excluded from the study.
We found this trial at
10
sites
2035 W Taylor St
Chicago, Illinois
(312) 996-4350
Principal Investigator: Valentin Prieto-Centurion, MD
University of Illinois at Chicago A major research university in the heart of one of...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Spyridon Fortis, MD
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Ann Arbor, Michigan 48106
Principal Investigator: Gary Peppin, MD
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1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
Principal Investigator: Russell Bowler, MD
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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Edina, Minnesota 55435
Principal Investigator: Kevin Grullon, MD
Phone: 952-567-7412
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Indianapolis, Indiana 46260
Principal Investigator: Michael Busk, MD
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Indianapolis, IN
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Louisville, Kentucky 40217
Principal Investigator: David Winslow, MD
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Louisville, KY
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Minneapolis, Minnesota 55407
Principal Investigator: Mitchell Kaye, MD
Phone: 952-567-7412
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Frank Sciurba, MD
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Woodbury, Minnesota 55125
Principal Investigator: Patrick Wright, MD
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Woodbury, MN
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