COPD
Conditions
Keywords
COPD, POC, Oxygen, QoL
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.
Interventions
COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)
Sponsors
Inogen Inc.
ResMed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity Level | 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
| Measure | Time frame | Description |
|---|---|---|
| St. George Respiratory Questionnaire (SGRQ) | 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. |
| Oxygen Usage | 12 weeks | Change in Total Hours of Use |
| Hospital Anxiety and Depression Scale (HADS): Anxiety | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Of Care (SOC) Standard of care long-term oxygen therapy | 50 |
| 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) | 46 |
| Total | 96 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 6 |
Baseline characteristics
| Characteristic | Standard Of Care (SOC) | SOC + POC (Portable Oxygen Concentrator) | Total |
|---|---|---|---|
| Age, Continuous | 67.3 years STANDARD_DEVIATION 7.9 | 70.2 years STANDARD_DEVIATION 9.7 | 68.8 years STANDARD_DEVIATION 8.8 |
| BMI | 29.7 kg/m^2 STANDARD_DEVIATION 7.8 | 30.7 kg/m^2 STANDARD_DEVIATION 7.4 | 30.2 kg/m^2 STANDARD_DEVIATION 7.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 44 Participants | 43 Participants | 87 Participants |
| Region of Enrollment United States | 50 participants | 46 participants | 96 participants |
| Sex: Female, Male Female | 31 Participants | 25 Participants | 56 Participants |
| Sex: Female, Male Male | 19 Participants | 21 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 54 | 0 / 54 |
| other Total, other adverse events | 21 / 54 | 16 / 54 |
| serious Total, serious adverse events | 6 / 54 | 1 / 54 |
Outcome results
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.
Time frame: 12 weeks
Population: Includes only patients that had evaluable PAL data (via ActiGraph watch) at both baseline and 12 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Of Care (SOC) | Physical Activity Level | 14.6 Ratio | Standard Deviation 232.1 |
| SOC + POC (Portable Oxygen Concentrator) | Physical Activity Level | -84.6 Ratio | Standard Deviation 1949.7 |
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.
Time frame: 12 weeks
Population: Only includes patients with complete HADS data at both Baseline and Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Of Care (SOC) | Hospital Anxiety and Depression Scale (HADS): Anxiety | 0.8 score on a scale HADS | Standard Deviation 4.1 |
| SOC + POC (Portable Oxygen Concentrator) | Hospital Anxiety and Depression Scale (HADS): Anxiety | -0.5 score on a scale HADS | Standard Deviation 3 |
Secondary
Oxygen Usage
Change in Total Hours of Use
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Of Care (SOC) | Oxygen Usage | 0.4 hours | Standard Deviation 2.5 |
| SOC + POC (Portable Oxygen Concentrator) | Oxygen Usage | -0.1 hours | Standard Deviation 3.1 |
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.
Time frame: 12 weeks
Population: Includes only patients with evaluable and complete SGRQ data at both Baseline and Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Of Care (SOC) | St. George Respiratory Questionnaire (SGRQ) | 1.1 score on a scale SGRQ | Standard Deviation 12.4 |
| SOC + POC (Portable Oxygen Concentrator) | St. George Respiratory Questionnaire (SGRQ) | -1.3 score on a scale SGRQ | Standard Deviation 9.1 |