COPDPOC-STEPNCT03513068
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)
A study testing Portable Oxygen Concentrator (POC) in people with COPD, run by ResMed at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Portable Oxygen Concentrator (POC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 11 sitesUnited States
- Study dates
- 24 Jul 2018to 2 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
ClinSite LLC
Ann Arbor, Michigan, 48106
University of Illinois, Chicago
Chicago, Illinois, 60608
National Jewish Health
Denver, Colorado, 80206
Minnesota Lung Center
Edina, Minnesota, 55435
St. Vincent Airways
Indianapolis, Indiana, 46260
University of Iowa
Iowa City, Iowa, 52242
Sierra Clinical Research
Las Vegas, Nevada, 89106
Kentucky Research Group
Louisville, Kentucky, 40218
Minnesota Lung Center
Minneapolis, Minnesota, 55407
UPMC Emphysema/COPD Research Center
Pittsburgh, Pennsylvania, 15213
Minnesota Lung Center
Woodbury, Minnesota, 55125
About this study
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.
- Conditions
- COPD
- Being tested
- Portable Oxygen Concentrator (POC)
- Keywords
- COPD, POC, Oxygen, QoL
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable Oxygen Concentrator (POC)Device
COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)
| Study group | Role | What they receive |
|---|---|---|
| Standard Of Care (SOC) | No intervention | Standard of care long-term oxygen therapy |
| SOC + POC (Portable Oxygen Concentrator) | Experimental | Standard of care long-term oxygen therapy + POC Receives: Device: Portable Oxygen Concentrator (POC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (3)
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.
Measured: 12 weeks
Oxygen Usage
Change in Total Hours of Use
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start24 Jul 2018
- Primary completion2 Sep 2020
- Study completion2 Sep 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by ResMedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Inogen Inc.
- Responsible party
- Sponsor
- Investigators
- MaryKay Sobcinski, Study chair, RCRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513068
- Sponsor's protocol ID
- MA-16-05-02
- Acronym
- POC-STEP
- Status last verified
- Sep 2021
- First submitted
- 11 Apr 2018
- Last updated
- 16 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03513068
- Acronym / sponsor ID
- POC-STEP / MA-16-05-02
- Conditions
- COPD
- Keywords
- COPD, POC, Oxygen, QoL
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 108 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Collaborators
- Inogen Inc.
- Study start
- 24 Jul 2018 (actual)
- Primary completion
- 2 Sep 2020 (actual)
- Study completion
- 2 Sep 2020 (actual)
- First posted
- 1 May 2018 (actual)
- Results
- Posted 16 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Of Care (SOC) | No intervention | –Standard of care long-term oxygen therapy |
| SOC + POC (Portable Oxygen Concentrator) | Experimental | Device: Portable Oxygen Concentrator (POC)Standard of care long-term oxygen therapy + POC |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portable Oxygen Concentrator (POC)COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC) | Device | SOC + POC (Portable Oxygen Concentrator) |
Primary outcome
Physical Activity Level
Time frame: 12 weeks
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.
3 secondary outcomes
St. George Respiratory Questionnaire (SGRQ)
Time frame: 12 weeks
Oxygen Usage
Time frame: 12 weeks
Hospital Anxiety and Depression Scale (HADS): Anxiety
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MaryKay Sobcinski study chair
RCRI
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portable Oxygen Concentrator (POC) in people with COPD, run by ResMed at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Level (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022; AzTrials last refreshed its copy on 6 Nov 2026.