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Trial record 1 of 2 for:    poc lean
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Evaluation of a Portable Oxygen Concentrator During Ambulation for Patients Who Require Supplemental Oxygen (POC-LEAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04107493
Recruitment Status : Recruiting
First Posted : September 27, 2019
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
ResMed

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 Other: Six Minutes Walk Tests Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 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.
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 : November 20, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Active Comparator: Portable oxygen cylinder
Continuous flow oxygen cylinders will be used as a comparison.
Other: Six Minutes Walk Tests

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.

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
Other: Six Minutes Walk Tests

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 Outcome Measures :
  1. Difference in mean SpO2 (oxygen saturation) during Six Minute Walk Tests (6MWTs) between Mobi™ and oxygen cylinder [ Time Frame: through study assessment completion, an average of 12 minutes (two six minutes walk) ]
    Each subject's SpO2 will be measured when each subject takes six minutes walk. Each subject take two six minutes walk at one visit. Each subject attends one visit.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04107493


Contacts
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Contact: Kimber Lee, MBA +6593719199 kimber.lee@resmed.com.sg

Locations
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United States, California
SleepData Recruiting
San Diego, California, United States, 92123
Contact: Samuel Clark, MD         
Sponsors and Collaborators
ResMed
Investigators
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Principal Investigator: Samuel Clark, M.D SleepData

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Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT04107493    
Other Study ID Numbers: MA-19-03-02
First Posted: September 27, 2019    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases