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

NCT04107493 | Completed Results FDA Device

• 1 other identifier: MA-19-03-02
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Portable oxygen cylinder

ACTIVE COMPARATOR

Continuous flow oxygen cylinders will be used as a comparison.

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

Device: Mobi

Interventions

Portable Oxygen Cylinder DEVICE

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

Also known as: POC

Portable oxygen cylinder

Mobi DEVICE

ResMed's variant of POC

Also known as: Mobi POC

Mobi™ Portable Oxygen Concentrator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• ResMed: lead

Study Sites (1)

SleepData

San Diego, California, 92123, United States

Location

Related Publications (2)

• 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.

  PMID: 31404750 BACKGROUND

• Guell 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.

  PMID: 18686732 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: maureen crocker
• Organization: ResMed

maureen.crocker@resmed.com

+1 8588366653

Study Officials

• Samuel Clark, M.D

  SleepData

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 27, 2019
• Study Start: November 21, 2019
• Primary Completion: March 9, 2020
• Study Completion: March 9, 2020
• Last Updated: May 26, 2021
• Results First Posted: May 26, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)