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)

Stopped early · Not applicable

Conditions studied: COPD

In brief

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.

Key facts

Study ID

NCT03513068

Run by

ResMed

People needed

108

Starts

2018-07-24

Expected to finish

2020-09-02

Last updated by the study team

2022-02-16

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is 40 years or older.
• Patient has a documented diagnosis of COPD.
• Patient qualifies for continuous (24/7) long-term oxygen therapy.
• Patient is prescribed oxygen at ≤ 5 L/min.
• Patient is POC-naïve, i.e., has not used a POC prior to enrolling in this study.
• Patient is able to tolerate pulsed oxygen therapy, i.e., oxygen delivered via a POC.
• Patient is able to fully understand study information and provide signed informed consent and HIPAA authorization.

You may not qualify if…

• Patient's condition is contraindicated for the use of a POC.
• Patient has uncontrolled or untreated sleep-disordered breathing that is uncontrolled or untreated.
• Patient is unable to complete the 6-minute walk test.
• 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.
• Patient has had thoracic surgery or another procedure in the six months prior to enrollment that is likely to cause instability of pulmonary status.
• Patient has an open skin ulcer or rash where the activity monitor will be worn on the body.
• Patient has a life expectancy < 1 year.
• Patient has non-COPD lung disease that may affect oxygenation or survival.
• Patient has a planned intervention(s) requiring hospitalization within the three months of study participation.
• Patient is pregnant or planning to become pregnant.
• Patient is participating in a clinical study of a medical product and has not completed the required follow-up period.
• Patient, in the opinion of the investigator, should be excluded from the study.

Where it is running

• National Jewish Health — Denver, Colorado, United States
• University of Illinois, Chicago — Chicago, Illinois, United States
• St. Vincent Airways — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• Kentucky Research Group — Louisville, Kentucky, United States
• ClinSite LLC — Ann Arbor, Michigan, United States
• Minnesota Lung Center — Edina, Minnesota, United States
• Minnesota Lung Center — Minneapolis, Minnesota, United States
• Minnesota Lung Center — Woodbury, Minnesota, United States
• Sierra Clinical Research — Las Vegas, Nevada, United States
• UPMC Emphysema/COPD Research Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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