Chronic Obstructive Pulmonary DiseaseNCT04107493
Evaluation of a Portable Oxygen Concentrator During Ambulation for Patients Who Require Supplemental Oxygen (POC-LEAN)
A study testing Portable Oxygen Cylinder and Mobi in people with Chronic Obstructive Pulmonary Disease, run by ResMed at 1 site in United States.
Trial summary
Prospective randomized study with a cross-over design. Mobi™ is a relatively new POC in the market and thus it is valuable to collect data from COPD patients using supplemental oxygen, and their use on Mobi™. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Portable Oxygen Cylinder and Mobi
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2019to 9 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Male or female, age ≥ 18 years at the time of signing informed consent.
- Diagnosed with COPD and currently in a stable state (at least 4 weeks since last exacerbation episode22).
- Current prescription for long-term oxygen therapy.
- Participants meet the criteria for pulse-dose portable oxygen delivery, defined as being mobile within the home and the qualifying blood gas study was performed at rest/ awake or during exercise.
- Participants who can read and comprehend English.
Who cannot join
- Clinically unstable, in the investigator's opinion, which might jeopardize the participant's safety or compliance with the protocol.
- Current oxygen therapy prescription for >5 L/min continuous flow.
- Known or suspected contraindication for pulse-dose oxygen.
- Unable to complete 6MWTs, e.g., unstable angina and myocardial infarction during the previous month
- Female who is pregnant, breast-feeding, or intends to become pregnant, or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice).
Trial locations and contacts
1 site in 1 country.
About this study
Prospective randomized study with a cross-over design. Mobi™ is a relatively new POC in the market and thus it is valuable to collect data from COPD patients using supplemental oxygen, and their use on Mobi™. The purpose of the present study is to compare Mobi™ with a continuous flow oxygen cylinder, with SpO2 as the primary endpoint.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Portable Oxygen Cylinder, Mobi
- 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 CylinderDevice
Also called POC
A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients
MobiDevice
Also called Mobi POC
ResMed's variant of POC
| Study group | Role | What they receive |
|---|---|---|
| Portable oxygen cylinder | Active comparator | Continuous flow oxygen cylinders will be used as a comparison. Receives: Device: Portable Oxygen Cylinder |
| Mobi™ Portable Oxygen Concentrator | Experimental | Mobi™ is indicated for patients who require supplemental oxygen, including COPD patients. It provides supplemental, high oxygen concentration to these patients. It is available via prescription only and may be used in the home, institution, and hospital settings, as well as travel environments Receives: Device: Mobi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean SpO2 (Oxygen Saturation) During Six Minute Walk Tests (6MWTs)
Each subject's SpO2 will be measured when each subject takes six minutes walk test
Measured: Mean Sp02, measured during 6 minute walk test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start21 Nov 2019
- Primary completion9 Mar 2020
- Study completion9 Mar 2020
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a prospective, randomized, cross-over study design with participants serving as their own controls. A within- participants, repeated-measures design is used during 6MWT. Eligible participants will complete two 6MWTs: one with their usual portable oxygen cylinder, and one with Mobi™. All participants entered into the study will be randomized in a 1:1 ratio to the following order of device use: * Control device (portable oxygen cylinder) first; or * Study device (Mobi™, POC) first.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samuel Clark, M.D, Principal investigator, SleepData
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107493
- Sponsor's protocol ID
- MA-19-03-02
- Status last verified
- May 2021
- First submitted
- 24 Sep 2019
- Last updated
- 26 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gloeckl R, Jarosch I, Schneeberger T, Fiedler C, Lausen M, Weingaertner J, Hitzl W, Kenn K, Koczulla AR. Comparison of supplemental oxygen delivery by continuous versus demand based flow systems in hypoxemic COPD patients - A randomized, single-blinded cross-over study. Respir Med. 2019 Sep;156:26-32. doi: 10.1016/j.rmed.2019.08.001. Epub 2019 Aug 5.
PubMed 31404750Guell Rous R. Long-term oxygen therapy: are we prescribing appropriately? Int J Chron Obstruct Pulmon Dis. 2008;3(2):231-7. doi: 10.2147/copd.s1230.
PubMed 18686732
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Portable Oxygen Concentrator During Ambulation for Patients Who Require Supplemental Oxygen (POC-LEAN)
- ClinicalTrials.gov ID
- NCT04107493
- Acronym / sponsor ID
- MA-19-03-02
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 27 Sep 2019 (actual)
- Results
- Posted 26 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective randomized study with a cross-over design. Mobi™ is a relatively new POC in the market and thus it is valuable to collect data from COPD patients using supplemental oxygen, and their use on Mobi™. The purpose of the present study is to compare Mobi™ with a continuous flow oxygen cylinder, with SpO2 as the primary endpoint.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, cross-over study design with participants serving as their own controls. A within- participants, repeated-measures design is used during 6MWT. Eligible participants will complete two 6MWTs: one with their usual portable oxygen cylinder, and one with Mobi™. All participants entered into the study will be randomized in a 1:1 ratio to the following order of device use: * Control device (portable oxygen cylinder) first; or * Study device (Mobi™, POC) first.
| Arm | Type | Receives |
|---|---|---|
| Portable oxygen cylinder | Active comparator | Device: Portable Oxygen CylinderContinuous flow oxygen cylinders will be used as a comparison. |
| Mobi™ Portable Oxygen Concentrator | Experimental | Device: MobiMobi™ is indicated for patients who require supplemental oxygen, including COPD patients. It provides supplemental, high oxygen concentration to these patients. It is available via prescription only and may be used in the home, institution, and hospital settings, as well as travel environments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Male or female, age ≥ 18 years at the time of signing informed consent.
- Diagnosed with COPD and currently in a stable state (at least 4 weeks since last exacerbation episode22).
- Current prescription for long-term oxygen therapy.
- Participants meet the criteria for pulse-dose portable oxygen delivery, defined as being mobile within the home and the qualifying blood gas study was performed at rest/ awake or during exercise.
Key exclusion criteria (5 listed)
- Clinically unstable, in the investigator's opinion, which might jeopardize the participant's safety or compliance with the protocol.
- Current oxygen therapy prescription for >5 L/min continuous flow.
- Known or suspected contraindication for pulse-dose oxygen.
- Unable to complete 6MWTs, e.g., unstable angina and myocardial infarction during the previous month
- Female who is pregnant, breast-feeding, or intends to become pregnant, or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice).
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 CylinderAlso: POCA POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients | Device | Portable oxygen cylinder |
| MobiAlso: Mobi POCResMed's variant of POC | Device | Mobi™ Portable Oxygen Concentrator |
Primary outcome
Mean SpO2 (Oxygen Saturation) During Six Minute Walk Tests (6MWTs)
Time frame: Mean Sp02, measured during 6 minute walk test
Each subject's SpO2 will be measured when each subject takes six minutes walk test
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31404750Gloeckl R, Jarosch I, Schneeberger T, Fiedler C, Lausen M, Weingaertner J, Hitzl W, Kenn K, Koczulla AR. Comparison of supplemental oxygen delivery by continuous versus demand based flow systems in hypoxemic COPD patients - A randomized, single-blinded cross-over study. Respir Med. 2019 Sep;156:26-32. doi: 10.1016/j.rmed.2019.08.001. Epub 2019 Aug 5.
- Background: PubMed 18686732Guell Rous R. Long-term oxygen therapy: are we prescribing appropriately? Int J Chron Obstruct Pulmon Dis. 2008;3(2):231-7. doi: 10.2147/copd.s1230.
- Individual participant dataSharing planned: No
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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.
Samuel Clark, M.D principal investigator
SleepData
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portable Oxygen Cylinder and Mobi in people with Chronic Obstructive Pulmonary Disease, run by ResMed at 1 site 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 26 May 2021). 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?
Mean SpO2 (Oxygen Saturation) During Six Minute Walk Tests (6MWTs) (time frame: Mean Sp02, measured during 6 minute walk test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04107493, which also lists 2 linked publications.
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 26 May 2021.