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OpenTrials
Completed

NCT Number: NCT04107493

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SleepData

San Diego, California, 92123, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Portable oxygen cylinder

Device

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

Other names: POC

Mobi

Device

ResMed's variant of POC

Other names: Mobi POC

Primary outcomes

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

    Time frame: Mean Sp02, measured during 6 minute walk test

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

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 27, 2019
Registry last updated
May 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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