Clinical trial NCT04107493: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2019-09-27
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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).

Primary outcomes:
measure: Mean SpO2 (Oxygen Saturation) During Six Minute Walk Tests (6MWTs)
timeFrame: Mean Sp02, measured during 6 minute walk test
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: SleepData
state: California
Study officials:
affiliation: SleepData
name: Samuel Clark, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.