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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Portable Oxygen Cylinder

Mobi

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

SleepData

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Portable oxygen cylinder

Mobi™ Portable Oxygen Concentrator

Arm Description

Continuous flow oxygen cylinders will be used as a comparison.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04107493

First Posted

September 24, 2019

Last Updated

May 24, 2021

Sponsor

ResMed

1. Study Identification

Unique Protocol Identification Number

NCT04107493

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

November 21, 2019 (Actual)

Primary Completion Date

March 9, 2020 (Actual)

Study Completion Date

March 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ResMed

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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)

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Portable oxygen cylinder

Arm Type

Active Comparator

Arm Description

Continuous flow oxygen cylinders will be used as a comparison.

Arm Title

Mobi™ Portable Oxygen Concentrator

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Portable Oxygen Cylinder

Other Intervention Name(s)

POC

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Mobi

Other Intervention Name(s)

Mobi POC

Intervention Description

ResMed's variant of POC

Primary Outcome Measure Information:

Title

Mean SpO2 (Oxygen Saturation) During Six Minute Walk Tests (6MWTs)

Description

Each subject's SpO2 will be measured when each subject takes six minutes walk test

Time Frame

Mean Sp02, measured during 6 minute walk test

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samuel Clark, M.D

Organizational Affiliation

SleepData

Official's Role

Principal Investigator

Facility Information:

Facility Name

SleepData

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31404750

Citation

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.

Results Reference

background

PubMed Identifier

18686732

Citation

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.

Results Reference

background

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

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