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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03513068
Recruitment Status : Terminated (COVID-19)
First Posted : May 1, 2018
Results First Posted : February 16, 2022
Last Update Posted : February 16, 2022
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) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 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
Actual Primary Completion Date : September 2, 2020
Actual Study Completion Date : September 2, 2020

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 Level [ Time Frame: 12 weeks ]
    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.


Secondary Outcome Measures :
  1. St. George Respiratory Questionnaire (SGRQ) [ Time Frame: 12 weeks ]
    Change in total SGRQ score between Week 12 and Baseline (Day1 ). Measures quality of life in patients with airway obstruction. Scores range from 0 to 100, with higher scores indicating more limitations.

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

  3. Hospital Anxiety and Depression Scale (HADS): Anxiety [ Time Frame: 12 weeks ]
    Outcome measure is the change from Baseline (Day 1) and Week 12. HADS questionnaire measures anxiety and depression. A patient can score between 0-21, scores of less than 7 indicate non-cases.



Information from the National Library of Medicine

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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


Locations
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United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
United States, Illinois
University of Illinois, Chicago
Chicago, Illinois, United States, 60608
United States, Indiana
St. Vincent Airways
Indianapolis, Indiana, United States, 46260
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kentucky
Kentucky Research Group
Louisville, Kentucky, United States, 40218
United States, Michigan
ClinSite LLC
Ann Arbor, Michigan, United States, 48106
United States, Minnesota
Minnesota Lung Center
Edina, Minnesota, United States, 55435
Minnesota Lung Center
Minneapolis, Minnesota, United States, 55407
Minnesota Lung Center
Woodbury, Minnesota, United States, 55125
United States, Nevada
Sierra Clinical Research
Las Vegas, Nevada, United States, 89106
United States, Pennsylvania
UPMC Emphysema/COPD Research Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
ResMed
Inogen Inc.
Investigators
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Study Chair: MaryKay Sobcinski RCRI
  Study Documents (Full-Text)

Documents provided by ResMed:
Study Protocol  [PDF] January 29, 2018
Statistical Analysis Plan  [PDF] August 18, 2020

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Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT03513068    
Other Study ID Numbers: MA-16-05-02
First Posted: May 1, 2018    Key Record Dates
Results First Posted: February 16, 2022
Last Update Posted: February 16, 2022
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
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, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases