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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-21

Study Completion Date

2020-03-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Oxygen Portable Concentrator During Exercises in Patients With COPD

NCT00875719

Chronic Obstructive Pulmonary Disease

COMPLETED NA

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)

NCT03513068

COPD

TERMINATED NA

Portable Oxygen Concentrator to Improve Quality of Life in Chronic Obstructive Pulmonary Disease

NCT01948544

COPD

COMPLETED

Effects of Supplemental Oxygen Delivered by a Portable Oxygen Concentrator Compared to a Liquid Oxygen Device in COPD

NCT03174210

Chronic Obstructive Pulmonary Disease

COMPLETED NA

Portable Oxygen Concentrator in Non-hospitalized Patients With Chronic Heart Failure

NCT05719363

Heart Failure

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Portable oxygen cylinder

Continuous flow oxygen cylinders will be used as a comparison.

Group Type ACTIVE_COMPARATOR

Portable Oxygen Cylinder

Intervention Type DEVICE

A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients

Mobi™ Portable Oxygen Concentrator

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

Group Type EXPERIMENTAL

Mobi

Intervention Type DEVICE

ResMed's variant of POC

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Portable Oxygen Cylinder

A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients

Intervention Type DEVICE

Mobi

ResMed's variant of POC

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

POC Mobi POC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 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.
2. Male or female, age ≥ 18 years at the time of signing informed consent.
3. Diagnosed with COPD and currently in a stable state (at least 4 weeks since last exacerbation episode22).
4. Current prescription for long-term oxygen therapy.
5. 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.
6. Participants who can read and comprehend English.

Exclusion Criteria

1. Clinically unstable, in the investigator's opinion, which might jeopardize the participant's safety or compliance with the protocol.
2. Current oxygen therapy prescription for \>5 L/min continuous flow.
3. Known or suspected contraindication for pulse-dose oxygen.
4. Unable to complete 6MWTs, e.g., unstable angina and myocardial infarction during the previous month
5. 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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No