Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Chronic Obstructive Pulmonary Disease, COPD
Brief summary
Chronic Obstructive Pulmonary Disease (COPD) affects over 14 million people in the United States. It is the fourth leading cause of death and the only leading cause of death for which mortality rates are rising. Medical science has developed few effective therapies for COPD. In patients with advanced COPD and chronic hypoxemia, long-term oxygen therapy (LTOT) has been shown to be uniquely beneficial. It is the only available non-surgical therapy demonstrated to prolong survival in these patients. This study will compare the clinical and physiologic benefits of two different oxygen therapy devices among hypoxemic individuals with COPD: a lightweight ambulatory oxygen device versus the standard portable E-cylinder device.
Detailed description
Individuals with COPD who experience hypoxemia (reduction of oxygen concentration in arterial blood) have an especially poor prognosis. Provision of LTOT to hypoxemic COPD patients is considered to be the standard of care. The majority of hypoxemic patients that are ambulatory are supplied with pressurized oxygen in E-cylinders. This system weighs approximately 22 pounds, is mounted on a wheeled cart, and is towed by the patient. These cumbersome systems can be seen to impose a significant burden on weak and debilitated patients, discouraging them from being active. E-cylinders towed on a cart are referred to as 'portable', in contrast to lightweight 'ambulatory' oxygen systems, which weigh less than 10 pounds and are designed to be carried by the patient. It is unknown whether patients provided with lightweight ambulatory systems comply better with oxygen prescription and increase their daily level of activity. This study will compare the use and benefits of a lightweight ambulatory oxygen device versus the standard portable E-cylinder device among hypoxemic individuals with COPD. Specifically, the study will examine daily duration of oxygen therapy and activity levels amongst both groups.
Interventions
DEVICEE-Cylinder
Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart
DEVICELightweight Cylinder
Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Chronic Obstructive Pulmonary Disease Clinical Research Network
University of Minnesota
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
* Currently in a stable phase of COPD, defined as having had no disease exacerbation within the 4 weeks prior to study entry * Ambulatory * Forced expiratory volume in one second (FEV1) less than or equal to 60% of predicted value at screening * Ratio of FEV1 and forced vital capacity (FEV1/FVC) less than or equal to 65% of predicted value at screening * Currently receiving long-term oxygen therapy (LTOT) * Partial pressure of oxygen in arterial blood (PaO2) less than 60 torr
Exclusion criteria
* Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, left-sided heart failure, peripheral vascular disease, exertional angina, complex arrhythmias, severe dependent edema, ischemic changes on stress electrocardiogram that would be contraindications for unrestricted ambulation or the 6-minute walk test) * Orthopedic impairments that would limit ambulation * Participation in the active phase of pulmonary rehabilitation within the 3 months prior to study entry * Neurologic impairments (e.g., Parkinson's disease or a stroke) or mental states (e.g., senile dementia) that would limit independent ambulation * Neoplastic disease that is anticipated to influence survival * Currently receiving lightweight ambulatory oxygen therapy * Inability to maintain an oxygen saturation of 92% at rest with 4 liter/minute of continuous oxygen flow and during exercise with an oxygen conserver setting of 6 utilizing a nasal cannula * Currently a smoker * Sleep apnea if it is characterized primarily as central sleep apnea syndrome (whether being treated or not) OR if it is known or suspected obstructive sleep apnea that has existed for at least 2 months and has not received stable treatment (stable treatment modes include positive airway pressure therapies or dental orthotic/mandibular positioning devices); individuals with diagnosed obstructive sleep apnea must have a body mass index less than or equal to 30 kg/m2 to be eligible for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stationary Oxygen Use Daily | 6 Months |
| Ambulatory/Portable Oxygen Use Daily | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Mid-day Activity Monitoring at 3 Months | 3 Months | Physical activity was monitored for 3 weeks before the 3-month visit using tri-axial accelerometers worn on a waist belt. Activity is expressed in vector magnitude units (VMU, the vectorial sum of activity counts in three orthogonal directions) per minute. Mid-day defined as 10AM-4PM. |
| Mid-day Activity Monitoring at 6 Months | 6 months | Physical activity was monitored for 3 weeks before the 6-month visit using tri-axial accelerometers worn on a waist belt. Activity is expressed in vector magnitude units (VMU, the vectorial sum of activity counts in three orthogonal directions) per minute. Mid-day defined as 10AM-4PM.). Mid-day defined as 10AM-4PM. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| E-Cylinder 22-lb E-cylinder towed on a cart
E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart | 11 |
| Lightweight Cylinder 3.6-lb lightweight cylinder that can be carried
Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder | 11 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 1 |
Baseline characteristics
| Characteristic | Lightweight Cylinder | Total | E-Cylinder |
|---|---|---|---|
| Age, Continuous | 67.1 years STANDARD_DEVIATION 8.1 | 66.9 years STANDARD_DEVIATION 9.2 | 66.6 years STANDARD_DEVIATION 10 |
| Cigarette Pack Years | 50.2 pack-years STANDARD_DEVIATION 20.1 | 53.3 pack-years STANDARD_DEVIATION 26 | 56.5 pack-years STANDARD_DEVIATION 31.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 22 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Forced expiratory volume in 1 second (FEV1) % Predicted | 37.1 Percent predicted STANDARD_DEVIATION 13 | 31.3 Percent predicted STANDARD_DEVIATION 10 | 30.1 Percent predicted STANDARD_DEVIATION 7.7 |
| Negative logarithm of hydrogen Ion concentration in arterial blood (pHa) | 7.42 pH units STANDARD_DEVIATION 0.03 | 7.42 pH units STANDARD_DEVIATION 0.03 | 7.42 pH units STANDARD_DEVIATION 0.03 |
| Partial pressure of carbon dioxide (PaCO2) | 45.4 torr STANDARD_DEVIATION 7.5 | 46.5 torr STANDARD_DEVIATION 7.3 | 47.5 torr STANDARD_DEVIATION 7.2 |
| Partial pressure of O2 (PaO2) | 49.5 torr STANDARD_DEVIATION 6.5 | 51.7 torr STANDARD_DEVIATION 6.4 | 53.7 torr STANDARD_DEVIATION 6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 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 | 8 Participants | 14 Participants | 6 Participants |
| Sex: Female, Male Female | 5 Participants | 8 Participants | 3 Participants |
| Sex: Female, Male Male | 6 Participants | 14 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 11 | 8 / 11 |
| serious Total, serious adverse events | 5 / 11 | 4 / 11 |
Outcome results
Primary
Ambulatory/Portable Oxygen Use Daily
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E-Cylinder | Ambulatory/Portable Oxygen Use Daily | 1.4 Hours | Standard Deviation 1 |
| Lightweight Cylinder | Ambulatory/Portable Oxygen Use Daily | 1.9 Hours | Standard Deviation 2.4 |
Primary
Stationary Oxygen Use Daily
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E-Cylinder | Stationary Oxygen Use Daily | 15.5 Hours | Standard Deviation 5.5 |
| Lightweight Cylinder | Stationary Oxygen Use Daily | 17.0 Hours | Standard Deviation 4.9 |
Primary
Stationary Oxygen Use Daily
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E-Cylinder | Stationary Oxygen Use Daily | 17.6 Hours | Standard Deviation 4.2 |
| Lightweight Cylinder | Stationary Oxygen Use Daily | 16.9 Hours | Standard Deviation 5.4 |
Secondary
Average Mid-day Activity Monitoring at 3 Months
Physical activity was monitored for 3 weeks before the 3-month visit using tri-axial accelerometers worn on a waist belt. Activity is expressed in vector magnitude units (VMU, the vectorial sum of activity counts in three orthogonal directions) per minute. Mid-day defined as 10AM-4PM.
Time frame: 3 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E-Cylinder | Average Mid-day Activity Monitoring at 3 Months | 81.4 Vector magnitude units (VMU)/min | Standard Deviation 36 |
| Lightweight Cylinder | Average Mid-day Activity Monitoring at 3 Months | 133.6 Vector magnitude units (VMU)/min | Standard Deviation 75.3 |
Secondary
Mid-day Activity Monitoring at 6 Months
Physical activity was monitored for 3 weeks before the 6-month visit using tri-axial accelerometers worn on a waist belt. Activity is expressed in vector magnitude units (VMU, the vectorial sum of activity counts in three orthogonal directions) per minute. Mid-day defined as 10AM-4PM.). Mid-day defined as 10AM-4PM.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E-Cylinder | Mid-day Activity Monitoring at 6 Months | 90.4 Vector magnitude units (VMU)/min | Standard Deviation 45.1 |
| Lightweight Cylinder | Mid-day Activity Monitoring at 6 Months | 124.2 Vector magnitude units (VMU)/min | Standard Deviation 73.8 |