Status:
COMPLETED
Evaluation of a Portable Oxygen Concentrator During Ambulation for Patients Who Require Supplemental Oxygen (POC-LEAN)
Lead Sponsor:
ResMed
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 o...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
November 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2020
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04107493
Start Date
November 21 2019
End Date
March 9 2020
Last Update
May 26 2021
Active Locations (1)
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1
SleepData
San Diego, California, United States, 92123