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Portable Oxygen Concentrator Improvements to Physical Activity, Oxygen Usage, and Quality of Life in Chronic Obstructive Pulmonary Disease Patients Using Long-term Oxygen Therapy (POC-STEP)

NCT03513068 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2022-02-16

Study results available
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Summary

To evaluate changes in activity based on the use of portable oxygen concentrators combined with standard of care (SOC) long- term oxygen therapy versus SOC long-term oxygen therapy alone at 12 weeks in patients with COPD who require continuous (24/7) long-term oxygen therapy. The study will also assess oxygen usage, quality of life, hospitalizations and death.

Conditions

Interventions

DEVICE

Portable Oxygen Concentrator (POC)

COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)

Sponsors & Collaborators

  • Inogen Inc.

    collaborator INDUSTRY

  • ResMed

    lead INDUSTRY

Principal Investigators

  • MaryKay Sobcinski · RCRI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-24
Primary Completion
2020-09-02
Completion
2020-09-02
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03513068 on ClinicalTrials.gov