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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) (POC-STEP)

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ClinicalTrials.gov Identifier: NCT03513068
Recruitment Status : Recruiting
First Posted : May 1, 2018
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
Inogen, Inc
Information provided by (Responsible Party):
ResMed

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.

Condition or disease Intervention/treatment Phase
COPD Device: Portable Oxygen Concentrator (POC) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : July 24, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard Of Care (SOC)
Standard of care long-term oxygen therapy
Experimental: SOC + POC (Portable Oxygen Concentrator)
Standard of care long-term oxygen therapy + POC
Device: Portable Oxygen Concentrator (POC)
COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)




Primary Outcome Measures :
  1. Physical Activity [ Time Frame: 12 weeks ]
    Change in physical activity measured through actigraphy, from baseline to 12 weeks.


Secondary Outcome Measures :
  1. St. George Respiratory Questionnaire (SGRQ) [ Time Frame: 12 weeks ]
    SGRQ measures quality of life in patients with airway obstruction.

  2. Oxygen Usage [ Time Frame: 12 weeks ]
    Hours of Use

  3. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 12 weeks ]
    HADS questionnaire measures anxiety and depression. A patient can score between 0-21, scores of less than 7 indicate non-cases.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patient's condition is contraindicated for the use of a POC.
  2. Patient has uncontrolled or untreated sleep-disordered breathing that is uncontrolled or untreated.
  3. Patient is unable to complete the 6-minute walk test.
  4. 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.
  5. Patient has had thoracic surgery or another procedure in the six months prior to enrollment that is likely to cause instability of pulmonary status.
  6. Patient has an open skin ulcer or rash where the activity monitor will be worn on the body.
  7. Patient has a life expectancy < 1 year.
  8. Patient has non-COPD lung disease that may affect oxygenation or survival.
  9. Patient has a planned intervention(s) requiring hospitalization within the three months of study participation.
  10. Patient is pregnant or planning to become pregnant.
  11. Patient is participating in a clinical study of a medical product and has not completed the required follow-up period.
  12. Patient, in the opinion of the investigator, should be excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03513068


Contacts
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Contact: Maureen E Crocker 8588366653 maureen.crocker@resmed.com

Locations
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United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Jennifer Underwood       underwoodj@njhealth.com   
Principal Investigator: Russell Bowler, MD         
United States, Illinois
University of Illinois, Chicago Recruiting
Chicago, Illinois, United States, 60608
Contact: Julia Luo       luo22@UIC.EDU   
Principal Investigator: Valentin Prieto-Centurion, MD         
United States, Indiana
St. Vincent Airways Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Ellen Looney       jloon002@ascension.org   
Principal Investigator: Michael Busk, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Thomas Sardone       thomas-sardone@uiowa.edu   
Principal Investigator: Spyridon Fortis, MD         
United States, Kentucky
Kentucky Research Group Recruiting
Louisville, Kentucky, United States, 40218
Contact: Jackie Bourke       jbourke@kyresearchgroup.com   
Principal Investigator: David Winslow, MD         
United States, Michigan
ClinSite LLC Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Sarah Yuhasz       Sarah_Yuhasz@ihacares.com   
Principal Investigator: Gary Peppin, MD         
United States, Minnesota
Minnesota Lung Center Recruiting
Edina, Minnesota, United States, 55435
Contact: Erik Wood    952-567-7412    erikw@mnlungresearch.com   
Principal Investigator: Kevin Grullon, MD         
Minnesota Lung Center Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Susan MacKinnon    952-567-7412    SueM@mnlungresearch.com   
Principal Investigator: Mitchell Kaye, MD         
Minnesota Lung Center Recruiting
Woodbury, Minnesota, United States, 55125
Contact: Kate Somers       kates@mnlungresearch.com   
Principal Investigator: Patrick Wright, MD         
United States, Pennsylvania
UPMC Emphysema/COPD Research Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Paula Consolaro       consolaropj@upmc.edu   
Principal Investigator: Frank Sciurba, MD         
Sponsors and Collaborators
ResMed
Inogen, Inc
Investigators
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Study Chair: MaryKay Sobcinski RCRI

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Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT03513068     History of Changes
Other Study ID Numbers: MA-16-05-02
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by ResMed:
COPD
POC
Oxygen
QoL

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases