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)

COPD Clinical Trial

— POC-STEP  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03513068
• Other study ID #: MA-16-05-02
• Status: Terminated
• Phase: N/A
• Start date: July 24, 2018
• Est. completion date: September 2, 2020

Study information

• Verified date: September 2021
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 108
• Est. completion date: September 2, 2020
• Est. primary completion date: September 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Portable Oxygen Concentrator (POC)
COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)

Locations

Country	Name	City	State
United States	ClinSite LLC	Ann Arbor	Michigan
United States	University of Illinois, Chicago	Chicago	Illinois
United States	National Jewish Health	Denver	Colorado
United States	Minnesota Lung Center	Edina	Minnesota
United States	St. Vincent Airways	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	Sierra Clinical Research	Las Vegas	Nevada
United States	Kentucky Research Group	Louisville	Kentucky
United States	Minnesota Lung Center	Minneapolis	Minnesota
United States	UPMC Emphysema/COPD Research Center	Pittsburgh	Pennsylvania
United States	Minnesota Lung Center	Woodbury	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
ResMed	Inogen Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	St. George Respiratory Questionnaire (SGRQ)	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.	12 weeks
Secondary	Oxygen Usage	Change in Total Hours of Use	12 weeks
Secondary	Hospital Anxiety and Depression Scale (HADS): Anxiety	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.	12 weeks