Evaluation of a Portable Oxygen Concentrator During Ambulation for Patients Who Require Supplemental Oxygen (POC-LEAN)

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of a Portable Oxygen Concentrator During Ambulation for Patients Who Require Supplemental Oxygen (POC-LEAN)

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: Portable Oxygen Cylinder
* Device: Mobi


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Portable oxygen cylinder<br>Continuous flow oxygen cylinders will be used as a comparison. | Device: Portable Oxygen Cylinder<br>* A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients<br>* Other names: POC;|
| Experimental: Mobi™ Portable Oxygen Concentrator<br>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 | Device: Mobi<br>* ResMed's variant of POC<br>* Other names: Mobi POC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Mean Sp02, measured during 6 minute walk test |