Clinical trial NCT03513068: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: COPD
Keywords: COPD
POC
Oxygen
QoL
Lead sponsor: ResMed
Sponsor class: INDUSTRY
Collaborators: name: Inogen Inc.
First posted: 2018-05-01
Enrollment: 108
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Physical Activity Level
timeFrame: 12 weeks
Secondary outcomes:
measure: St. George Respiratory Questionnaire (SGRQ)
timeFrame: 12 weeks
measure: Oxygen Usage
timeFrame: 12 weeks
measure: Hospital Anxiety and Depression Scale (HADS): Anxiety
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Chicago
country: United States
facility: University of Illinois, Chicago
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Airways
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Louisville
country: United States
facility: Kentucky Research Group
state: Kentucky
city: Ann Arbor
country: United States
facility: ClinSite LLC
state: Michigan
city: Edina
country: United States
facility: Minnesota Lung Center
state: Minnesota
city: Minneapolis
country: United States
facility: Minnesota Lung Center
state: Minnesota
city: Woodbury
country: United States
facility: Minnesota Lung Center
state: Minnesota
city: Las Vegas
country: United States
facility: Sierra Clinical Research
state: Nevada
city: Pittsburgh
country: United States
facility: UPMC Emphysema/COPD Research Center
state: Pennsylvania
Study officials:
affiliation: RCRI
name: MaryKay Sobcinski
role: STUDY_CHAIR
References: