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 | Terminated Results FDA Device

• 1 other identifier: MA-16-05-02
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 11

Brief 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

COPD

Keywords

COPD; POC; Oxygen; QoL

Outcome Measures

Primary Outcomes (1)

• Physical Activity Level

  Change in physical activity level (PAL) as measured through actigraphy. Outcome measure is the change between the value at Week 12 and Day 1 (Baseline). Min = 0; Max = infinite. A large positive change would indicate the participant increased their activity level at 12 weeks in comparison to Day 1. Physical activity level (PAL) is the ratio of total energy expenditure (TEE) to sleep energy expenditure (SEE). TEE is the total number of wear-filtered kilocalories expended in a day and SEE is the total number of sleep- and wear-filtered kilocalories expended in a day.

  12 weeks

Secondary Outcomes (3)

• St. George Respiratory Questionnaire (SGRQ)

  12 weeks

• Oxygen Usage

  12 weeks

• Hospital Anxiety and Depression Scale (HADS): Anxiety

  12 weeks

Study Arms (2)

Standard Of Care (SOC)

NO INTERVENTION

Standard of care long-term oxygen therapy

SOC + POC (Portable Oxygen Concentrator)

EXPERIMENTAL

Standard of care long-term oxygen therapy + POC

Device: Portable Oxygen Concentrator (POC)

Interventions

Portable Oxygen Concentrator (POC) DEVICE

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

SOC + POC (Portable Oxygen Concentrator)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is 40 years or older.
• Patient has a documented diagnosis of COPD.
• Patient qualifies for continuous (24/7) long-term oxygen therapy.
• Patient is prescribed oxygen at ≤ 5 L/min.
• Patient is POC-naïve, i.e., has not used a POC prior to enrolling in this study.
• Patient is able to tolerate pulsed oxygen therapy, i.e., oxygen delivered via a POC.
• Patient is able to fully understand study information and provide signed informed consent and HIPAA authorization.

You may not qualify if:

• Patient's condition is contraindicated for the use of a POC.
• Patient has uncontrolled or untreated sleep-disordered breathing that is uncontrolled or untreated.
• Patient is unable to complete the 6-minute walk test.
• Patient has a diagnosis (within less than two weeks prior to study entry) of pneumonia or respiratory infection, and/or acute bronchitis requiring antibiotics, or new/increased dose of systemic corticosteroids.
• Patient has had thoracic surgery or another procedure in the six months prior to enrollment that is likely to cause instability of pulmonary status.
• Patient has an open skin ulcer or rash where the activity monitor will be worn on the body.
• Patient has a life expectancy \< 1 year.
• Patient has non-COPD lung disease that may affect oxygenation or survival.
• Patient has a planned intervention(s) requiring hospitalization within the three months of study participation.
• Patient is pregnant or planning to become pregnant.
• Patient is participating in a clinical study of a medical product and has not completed the required follow-up period.
• Patient, in the opinion of the investigator, should be excluded from the study.

Sponsors & Collaborators

• ResMed: lead
• Inogen Inc.: collaborator

Study Sites (11)

National Jewish Health

Denver, Colorado, 80206, United States

Location

University of Illinois, Chicago

Chicago, Illinois, 60608, United States

Location

St. Vincent Airways

Indianapolis, Indiana, 46260, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Kentucky Research Group

Louisville, Kentucky, 40218, United States

Location

ClinSite LLC

Ann Arbor, Michigan, 48106, United States

Location

Minnesota Lung Center

Edina, Minnesota, 55435, United States

Location

Minnesota Lung Center

Minneapolis, Minnesota, 55407, United States

Location

Minnesota Lung Center

Woodbury, Minnesota, 55125, United States

Location

Sierra Clinical Research

Las Vegas, Nevada, 89106, United States

Location

UPMC Emphysema/COPD Research Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Maureen Crocker, Sr. Manager Market Access
• Organization: ResMed

maureen.crocker@resmed.com

+65 9815 2195

Study Officials

• MaryKay Sobcinski

  RCRI

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: May 1, 2018
• Study Start: July 24, 2018
• Primary Completion: September 2, 2020
• Study Completion: September 2, 2020
• Last Updated: February 16, 2022
• Results First Posted: February 16, 2022

Record last verified: 2021-09

Locations

US (11)