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

• Sponsor: ResMed (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04107493
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.6
• Patients Per Site Per Month: 9.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Device: Portable Oxygen Cylinder; Device: Mobi	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention 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.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)
• Primary Purpose: Supportive Care
• Official Title: Evaluation of a Portable Oxygen Concentrator During Ambulation for Patients Who Require Supplemental Oxygen (POC-LEAN)
• Actual Study Start Date: Nov 21, 2019
• Actual Primary Completion Date: Mar 9, 2020
• Actual Study Completion Date: Mar 9, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Portable oxygen cylinder Continuous flow oxygen cylinders will be used as a comparison.	Device: Portable Oxygen Cylinder; A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients; Other Names: POC
Experimental: 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	Device: Mobi; ResMed's variant of POC; Other Names: Mobi POC

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SleepData	San Diego	California	United States	92123

Sponsors and Collaborators

• ResMed

Investigators

• Principal Investigator: Samuel Clark, M.D, SleepData

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 15, 2020

More Information

Publications

• 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.
• Güell Rous R. Long-term oxygen therapy: are we prescribing appropriately? Int J Chron Obstruct Pulmon Dis. 2008;3(2):231-7. Review.

• Responsible Party: ResMed
• ClinicalTrials.gov Identifier: NCT04107493
• Other Study ID Numbers: MA-19-03-02
• First Posted: Sep 27, 2019
• Last Update Posted: May 26, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Study Results

Participant Flow

Pre-assignment Detail	Participants acted as their own controls. Participants were randomised as to the order they used the devices during the 6-minute walking test. There was a one hour wash out period between tests

Arm/Group Title	Portable Oxygen Cylinder, Then Mobi	Mobi, Then Portable Oxygen Cylinder
Arm/Group Description	Participants acted as their own control in this study. Participants used two portable oxygen cylinders during a 6 minute walk test. One was a standard POC, and one was the trial device, the Mobi POC Portable Oxygen Cylinder: A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients	Participants acted as their own control in this study. Participants used two portable oxygen cylinders during a 6 minute walk test. One was a standard POC, and one was the trial device, the Mobi POC Portable Oxygen Cylinder: A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients
Period Title: First Intervention (1 Hour)
STARTED	16	17
COMPLETED	16	17
NOT COMPLETED	0	0
Period Title: First Intervention (1 Hour)
STARTED	16	17
COMPLETED	16	17
NOT COMPLETED	0	0
Period Title: First Intervention (1 Hour)
STARTED	16	17
COMPLETED	16	17
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	Participants acted as their own control during this study. Participants used a portable oxygen cylinder whilst doing a 6 minute walking test. After a wash out period the participants completed the 6 minute walking test with the second portable oxygen cylinder. The order of the oxygen cylinders (mobi or standard) was randomised
Overall Participants	33
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.86 (8.82)
Sex: Female, Male (Count of Participants)
Female	21 63.6%
Male	12 36.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 9.1%
Not Hispanic or Latino	30 90.9%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 3%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 3%
White	29 87.9%
More than one race	0 0%
Unknown or Not Reported	2 6.1%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Portable Oxygen Cylinder	Mobi™ Portable Oxygen Concentrator
Arm/Group Description	Continuous flow oxygen cylinders will be used as a comparison. Portable Oxygen Cylinder: A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients	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 Mobi: ResMed's variant of POC
Measure Participants	33	33
Mean (Standard Error) [percentage of oxygen saturation]	91.2 (0.7)	90.0 (0.7)

Adverse Events

Time Frame	Adverse events were collected during the one study visit. After completion of this visit, the participants involvement in the study was completed
Arm/Group Title	Standard Oxygen Cylinder		Mobi
Arm/Group Description	Participants acted as their own control in this study. Participants used two portable oxygen cylinders during a 6 minute walk test. One was a standard POC, and one was the trial device, the Mobi POC Portable Oxygen Cylinder: A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients		Participants acted as their own control in this study. Participants used two portable oxygen cylinders during a 6 minute walk test. One was a standard POC, and one was the trial device, the Mobi POC Portable Oxygen Cylinder: A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients
All Cause Mortality
	Standard Oxygen Cylinder		Mobi
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/33 (0%)
Serious Adverse Events
	Standard Oxygen Cylinder		Mobi
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/33 (0%)
Other (Not Including Serious) Adverse Events
	Standard Oxygen Cylinder		Mobi
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/33 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.