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

Not Applicable

Completed

Brief 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™. The purpose of the present study is to compare Mobi™ with a continuous flow oxygen cylinder, with SpO2 as the primary endpoint.

Recruitment & Eligibility

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).

Arm && Interventions

Group	Intervention	Description
Mobi™ Portable Oxygen Concentrator	Mobi	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
Portable oxygen cylinder	Portable Oxygen Cylinder	Continuous flow oxygen cylinders will be used as a comparison.

Primary Outcome Measures

Name	Time	Method
Mean SpO2 (Oxygen Saturation) During Six Minute Walk Tests (6MWTs)	Mean Sp02, measured during 6 minute walk test	Each subject's SpO2 will be measured when each subject takes six minutes walk test

Secondary Outcome Measures