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

Completed · Not applicable

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT04107493

Run by

ResMed

People needed

33

Starts

2019-11-21

Expected to finish

2020-03-09

Last updated by the study team

2021-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• SleepData — San Diego, California, United States

Full record on ClinicalTrials.gov

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