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) (POC-STEP)
Primary Purpose
COPD
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Portable Oxygen Concentrator (POC)
Sponsored by
![ResMed](https://trials-media.s3.amazonaws.com/orgs/resmed.jpeg)
About this trial
This is an interventional treatment trial for COPD focused on measuring COPD, POC, Oxygen, QoL
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- National Jewish Health
- University of Illinois, Chicago
- St. Vincent Airways
- University of Iowa
- Kentucky Research Group
- ClinSite LLC
- Minnesota Lung Center
- Minnesota Lung Center
- Minnesota Lung Center
- Sierra Clinical Research
- UPMC Emphysema/COPD Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard Of Care (SOC)
SOC + POC (Portable Oxygen Concentrator)
Arm Description
Standard of care long-term oxygen therapy
Standard of care long-term oxygen therapy + POC
Outcomes
Primary Outcome Measures
Physical Activity Level
Change in physical activity level (PAL) as measured through actigraphy. Outcome measure is the change between the value at Week 12 and Day 1 (Baseline). Min = 0; Max = infinite. A large positive change would indicate the participant increased their activity level at 12 weeks in comparison to Day 1. Physical activity level (PAL) is the ratio of total energy expenditure (TEE) to sleep energy expenditure (SEE). TEE is the total number of wear-filtered kilocalories expended in a day and SEE is the total number of sleep- and wear-filtered kilocalories expended in a day.
Secondary Outcome Measures
St. George Respiratory Questionnaire (SGRQ)
Change in total SGRQ score between Week 12 and Baseline (Day1 ). Measures quality of life in patients with airway obstruction. Scores range from 0 to 100, with higher scores indicating more limitations.
Oxygen Usage
Change in Total Hours of Use
Hospital Anxiety and Depression Scale (HADS): Anxiety
Outcome measure is the change from Baseline (Day 1) and Week 12. HADS questionnaire measures anxiety and depression. A patient can score between 0-21, scores of less than 7 indicate non-cases.
Full Information
NCT ID
NCT03513068
First Posted
April 11, 2018
Last Updated
January 25, 2022
Sponsor
ResMed
Collaborators
Inogen Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03513068
Brief 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)
Acronym
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
COVID-19
Study Start Date
July 24, 2018 (Actual)
Primary Completion Date
September 2, 2020 (Actual)
Study Completion Date
September 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed
Collaborators
Inogen Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
COPD, POC, Oxygen, QoL
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Of Care (SOC)
Arm Type
No Intervention
Arm Description
Standard of care long-term oxygen therapy
Arm Title
SOC + POC (Portable Oxygen Concentrator)
Arm Type
Experimental
Arm Description
Standard of care long-term oxygen therapy + POC
Intervention Type
Device
Intervention Name(s)
Portable Oxygen Concentrator (POC)
Intervention Description
COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)
Primary Outcome Measure Information:
Title
Physical Activity Level
Description
Change in physical activity level (PAL) as measured through actigraphy. Outcome measure is the change between the value at Week 12 and Day 1 (Baseline). Min = 0; Max = infinite. A large positive change would indicate the participant increased their activity level at 12 weeks in comparison to Day 1. Physical activity level (PAL) is the ratio of total energy expenditure (TEE) to sleep energy expenditure (SEE). TEE is the total number of wear-filtered kilocalories expended in a day and SEE is the total number of sleep- and wear-filtered kilocalories expended in a day.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
St. George Respiratory Questionnaire (SGRQ)
Description
Change in total SGRQ score between Week 12 and Baseline (Day1 ). Measures quality of life in patients with airway obstruction. Scores range from 0 to 100, with higher scores indicating more limitations.
Time Frame
12 weeks
Title
Oxygen Usage
Description
Change in Total Hours of Use
Time Frame
12 weeks
Title
Hospital Anxiety and Depression Scale (HADS): Anxiety
Description
Outcome measure is the change from Baseline (Day 1) and Week 12. HADS questionnaire measures anxiety and depression. A patient can score between 0-21, scores of less than 7 indicate non-cases.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MaryKay Sobcinski
Organizational Affiliation
RCRI
Official's Role
Study Chair
Facility Information:
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
University of Illinois, Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Facility Name
St. Vincent Airways
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Kentucky Research Group
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40218
Country
United States
Facility Name
ClinSite LLC
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Minnesota Lung Center
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Minnesota Lung Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Minnesota Lung Center
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Sierra Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
UPMC Emphysema/COPD Research Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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)
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