Trial Outcomes & Findings for 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) (NCT NCT03513068)

Last Updated: 2022-02-16

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

108 participants

Primary outcome timeframe

12 weeks

Results posted on

2022-02-16

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Of Care (SOC) Standard of care long-term oxygen therapy	SOC + POC (Portable Oxygen Concentrator) Standard of care long-term oxygen therapy + POC Portable Oxygen Concentrator (POC): COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)
Overall Study STARTED	54	54
Overall Study COMPLETED	49	48
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard Of Care (SOC) Standard of care long-term oxygen therapy	SOC + POC (Portable Oxygen Concentrator) Standard of care long-term oxygen therapy + POC Portable Oxygen Concentrator (POC): COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)
Overall Study Death	1	0
Overall Study Withdrawal by Subject	4	6

Baseline Characteristics

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)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Of Care (SOC) n=50 Participants Standard of care long-term oxygen therapy	SOC + POC (Portable Oxygen Concentrator) n=46 Participants Standard of care long-term oxygen therapy + POC Portable Oxygen Concentrator (POC): COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)	Total n=96 Participants Total of all reporting groups
Age, Continuous	67.3 years STANDARD_DEVIATION 7.9 • n=5 Participants	70.2 years STANDARD_DEVIATION 9.7 • n=7 Participants	68.8 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	25 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	44 Participants n=5 Participants	43 Participants n=7 Participants	87 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	46 participants n=7 Participants	96 participants n=5 Participants
BMI	29.7 kg/m^2 STANDARD_DEVIATION 7.8 • n=5 Participants	30.7 kg/m^2 STANDARD_DEVIATION 7.4 • n=7 Participants	30.2 kg/m^2 STANDARD_DEVIATION 7.6 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Includes only patients that had evaluable PAL data (via ActiGraph watch) at both baseline and 12 weeks.

Outcome measures

Outcome measures
Measure	Standard Of Care (SOC) n=40 Participants Standard of care long-term oxygen therapy	SOC + POC (Portable Oxygen Concentrator) n=31 Participants Standard of care long-term oxygen therapy + POC Portable Oxygen Concentrator (POC): COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)
Physical Activity Level	14.6 Ratio Standard Deviation 232.1	-84.6 Ratio Standard Deviation 1949.7

SECONDARY outcome

Timeframe: 12 weeks

Population: Includes only patients with evaluable and complete SGRQ data at both Baseline and Week 12.

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.

Outcome measures

Outcome measures
Measure	Standard Of Care (SOC) n=48 Participants Standard of care long-term oxygen therapy	SOC + POC (Portable Oxygen Concentrator) n=45 Participants Standard of care long-term oxygen therapy + POC Portable Oxygen Concentrator (POC): COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)
St. George Respiratory Questionnaire (SGRQ)	1.1 score on a scale SGRQ Standard Deviation 12.4	-1.3 score on a scale SGRQ Standard Deviation 9.1

SECONDARY outcome

Timeframe: 12 weeks

Change in Total Hours of Use

Outcome measures

Outcome measures
Measure	Standard Of Care (SOC) n=46 Participants Standard of care long-term oxygen therapy	SOC + POC (Portable Oxygen Concentrator) n=43 Participants Standard of care long-term oxygen therapy + POC Portable Oxygen Concentrator (POC): COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)
Oxygen Usage	0.4 hours Standard Deviation 2.5	-0.1 hours Standard Deviation 3.1

SECONDARY outcome

Timeframe: 12 weeks

Population: Only includes patients with complete HADS data at both Baseline and Week 12.

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.

Outcome measures

Outcome measures
Measure	Standard Of Care (SOC) n=48 Participants Standard of care long-term oxygen therapy	SOC + POC (Portable Oxygen Concentrator) n=45 Participants Standard of care long-term oxygen therapy + POC Portable Oxygen Concentrator (POC): COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)
Hospital Anxiety and Depression Scale (HADS): Anxiety	0.8 score on a scale HADS Standard Deviation 4.1	-0.5 score on a scale HADS Standard Deviation 3.0

Adverse Events

Standard Of Care (SOC)

Serious events: 6 serious events

Other events: 21 other events

Deaths: 1 deaths

SOC + POC (Portable Oxygen Concentrator)

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Standard Of Care (SOC) n=54 participants at risk Standard of care long-term oxygen therapy	SOC + POC (Portable Oxygen Concentrator) n=54 participants at risk Standard of care long-term oxygen therapy + POC Portable Oxygen Concentrator (POC): COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)
Respiratory, thoracic and mediastinal disorders COPD Exacerbation	7.4% 4/54 • Number of events 4 • Duration of the study = 12 weeks. All AEs were collected during the course of the study. Events were categorized as hospitalizations or exacerbations of COPD, respiratory-related event, or Other. Trial sites and Investigators were allowed to capture non-categorized events as "Other".	1.9% 1/54 • Number of events 3 • Duration of the study = 12 weeks. All AEs were collected during the course of the study. Events were categorized as hospitalizations or exacerbations of COPD, respiratory-related event, or Other. Trial sites and Investigators were allowed to capture non-categorized events as "Other".
Respiratory, thoracic and mediastinal disorders Other respiratory-related condition	1.9% 1/54 • Number of events 1 • Duration of the study = 12 weeks. All AEs were collected during the course of the study. Events were categorized as hospitalizations or exacerbations of COPD, respiratory-related event, or Other. Trial sites and Investigators were allowed to capture non-categorized events as "Other".	1.9% 1/54 • Number of events 2 • Duration of the study = 12 weeks. All AEs were collected during the course of the study. Events were categorized as hospitalizations or exacerbations of COPD, respiratory-related event, or Other. Trial sites and Investigators were allowed to capture non-categorized events as "Other".
General disorders Other	1.9% 1/54 • Number of events 1 • Duration of the study = 12 weeks. All AEs were collected during the course of the study. Events were categorized as hospitalizations or exacerbations of COPD, respiratory-related event, or Other. Trial sites and Investigators were allowed to capture non-categorized events as "Other".	1.9% 1/54 • Number of events 7 • Duration of the study = 12 weeks. All AEs were collected during the course of the study. Events were categorized as hospitalizations or exacerbations of COPD, respiratory-related event, or Other. Trial sites and Investigators were allowed to capture non-categorized events as "Other".

Other adverse events

Other adverse events
Measure	Standard Of Care (SOC) n=54 participants at risk Standard of care long-term oxygen therapy	SOC + POC (Portable Oxygen Concentrator) n=54 participants at risk Standard of care long-term oxygen therapy + POC Portable Oxygen Concentrator (POC): COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)
Respiratory, thoracic and mediastinal disorders COPD Exacerbation	25.9% 14/54 • Number of events 15 • Duration of the study = 12 weeks. All AEs were collected during the course of the study. Events were categorized as hospitalizations or exacerbations of COPD, respiratory-related event, or Other. Trial sites and Investigators were allowed to capture non-categorized events as "Other".	18.5% 10/54 • Number of events 12 • Duration of the study = 12 weeks. All AEs were collected during the course of the study. Events were categorized as hospitalizations or exacerbations of COPD, respiratory-related event, or Other. Trial sites and Investigators were allowed to capture non-categorized events as "Other".
Respiratory, thoracic and mediastinal disorders Other respiratory-related condition	9.3% 5/54 • Number of events 5 • Duration of the study = 12 weeks. All AEs were collected during the course of the study. Events were categorized as hospitalizations or exacerbations of COPD, respiratory-related event, or Other. Trial sites and Investigators were allowed to capture non-categorized events as "Other".	3.7% 2/54 • Number of events 3 • Duration of the study = 12 weeks. All AEs were collected during the course of the study. Events were categorized as hospitalizations or exacerbations of COPD, respiratory-related event, or Other. Trial sites and Investigators were allowed to capture non-categorized events as "Other".
General disorders Other	13.0% 7/54 • Number of events 9 • Duration of the study = 12 weeks. All AEs were collected during the course of the study. Events were categorized as hospitalizations or exacerbations of COPD, respiratory-related event, or Other. Trial sites and Investigators were allowed to capture non-categorized events as "Other".	16.7% 9/54 • Number of events 17 • Duration of the study = 12 weeks. All AEs were collected during the course of the study. Events were categorized as hospitalizations or exacerbations of COPD, respiratory-related event, or Other. Trial sites and Investigators were allowed to capture non-categorized events as "Other".

Additional Information

Maureen Crocker, Sr. Manager Market Access

ResMed

Phone: +65 9815 2195

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place