Trial Outcomes & Findings for Benefits of Lightweight Ambulatory Oxygen Systems for Individuals With Chronic Obstructive Pulmonary Disease (NCT NCT00325754)
NCT ID: NCT00325754
Last Updated: 2019-11-18
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
6 Months
Results posted on
2019-11-18
Participant Flow
Participant milestones
| Measure |
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
|
Lightweight Cylinder
3.6-lb lightweight cylinder that can be carried
Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
7
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
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
|
Lightweight Cylinder
3.6-lb lightweight cylinder that can be carried
Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
1
|
Baseline Characteristics
Benefits of Lightweight Ambulatory Oxygen Systems for Individuals With Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
E-Cylinder
n=11 Participants
22-lb E-cylinder towed on a cart
E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart
|
Lightweight Cylinder
n=11 Participants
3.6-lb lightweight cylinder that can be carried
Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.6 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
67.1 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
66.9 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 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
|
|
Cigarette Pack Years
|
56.5 pack-years
STANDARD_DEVIATION 31.2 • n=5 Participants
|
50.2 pack-years
STANDARD_DEVIATION 20.1 • n=7 Participants
|
53.3 pack-years
STANDARD_DEVIATION 26.0 • n=5 Participants
|
|
Forced expiratory volume in 1 second (FEV1) % Predicted
|
30.1 Percent predicted
STANDARD_DEVIATION 7.7 • n=5 Participants
|
37.1 Percent predicted
STANDARD_DEVIATION 13.0 • n=7 Participants
|
31.3 Percent predicted
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Partial pressure of O2 (PaO2)
|
53.7 torr
STANDARD_DEVIATION 6.0 • n=5 Participants
|
49.5 torr
STANDARD_DEVIATION 6.5 • n=7 Participants
|
51.7 torr
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Partial pressure of carbon dioxide (PaCO2)
|
47.5 torr
STANDARD_DEVIATION 7.2 • n=5 Participants
|
45.4 torr
STANDARD_DEVIATION 7.5 • n=7 Participants
|
46.5 torr
STANDARD_DEVIATION 7.3 • n=5 Participants
|
|
Negative logarithm of hydrogen Ion concentration in arterial blood (pHa)
|
7.42 pH units
STANDARD_DEVIATION 0.03 • n=5 Participants
|
7.42 pH units
STANDARD_DEVIATION 0.03 • n=7 Participants
|
7.42 pH units
STANDARD_DEVIATION 0.03 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsOutcome measures
| Measure |
E-Cylinder
n=7 Participants
22-lb E-cylinder towed on a cart
E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart
|
Lightweight Cylinder
n=10 Participants
3.6-lb lightweight cylinder that can be carried
Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder
|
|---|---|---|
|
Stationary Oxygen Use Daily
|
15.5 Hours
Standard Deviation 5.5
|
17.0 Hours
Standard Deviation 4.9
|
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
E-Cylinder
n=7 Participants
22-lb E-cylinder towed on a cart
E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart
|
Lightweight Cylinder
n=10 Participants
3.6-lb lightweight cylinder that can be carried
Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder
|
|---|---|---|
|
Ambulatory/Portable Oxygen Use Daily
|
1.4 Hours
Standard Deviation 1.0
|
1.9 Hours
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: BaselineOutcome measures
| Measure |
E-Cylinder
n=7 Participants
22-lb E-cylinder towed on a cart
E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart
|
Lightweight Cylinder
n=10 Participants
3.6-lb lightweight cylinder that can be carried
Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder
|
|---|---|---|
|
Stationary Oxygen Use Daily
|
17.6 Hours
Standard Deviation 4.2
|
16.9 Hours
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: 3 MonthsPhysical 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.
Outcome measures
| Measure |
E-Cylinder
n=11 Participants
22-lb E-cylinder towed on a cart
E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart
|
Lightweight Cylinder
n=11 Participants
3.6-lb lightweight cylinder that can be carried
Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder
|
|---|---|---|
|
Average Mid-day Activity Monitoring at 3 Months
|
81.4 Vector magnitude units (VMU)/min
Standard Deviation 36.0
|
133.6 Vector magnitude units (VMU)/min
Standard Deviation 75.3
|
SECONDARY outcome
Timeframe: 6 monthsPhysical 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.
Outcome measures
| Measure |
E-Cylinder
n=7 Participants
22-lb E-cylinder towed on a cart
E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart
|
Lightweight Cylinder
n=10 Participants
3.6-lb lightweight cylinder that can be carried
Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder
|
|---|---|---|
|
Mid-day Activity Monitoring at 6 Months
|
90.4 Vector magnitude units (VMU)/min
Standard Deviation 45.1
|
124.2 Vector magnitude units (VMU)/min
Standard Deviation 73.8
|
Adverse Events
E-Cylinder
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Lightweight Cylinder
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
E-Cylinder
n=11 participants at risk
22-lb E-cylinder towed on a cart
E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart
|
Lightweight Cylinder
n=11 participants at risk
3.6-lb lightweight cylinder that can be carried
Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder
|
|---|---|---|
|
Endocrine disorders
Angioedema
|
0.00%
0/11 • 6 months
|
9.1%
1/11 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/11 • 6 months
|
9.1%
1/11 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/11 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/11 • 6 months
|
9.1%
1/11 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/11 • 6 months
|
|
Gastrointestinal disorders
Inguinal Hernia
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/11 • 6 months
|
|
General disorders
Chest Pain
|
0.00%
0/11 • 6 months
|
9.1%
1/11 • Number of events 1 • 6 months
|
|
General disorders
Shortness of Breath
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/11 • 6 months
|
|
General disorders
Sudden Death
|
9.1%
1/11 • Number of events 1 • 6 months
|
9.1%
1/11 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
E-Cylinder
n=11 participants at risk
22-lb E-cylinder towed on a cart
E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart
|
Lightweight Cylinder
n=11 participants at risk
3.6-lb lightweight cylinder that can be carried
Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Infection
|
18.2%
2/11 • Number of events 2 • 6 months
|
18.2%
2/11 • Number of events 5 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/11 • 6 months
|
9.1%
1/11 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/11 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/11 • 6 months
|
18.2%
2/11 • Number of events 4 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
18.2%
2/11 • Number of events 4 • 6 months
|
9.1%
1/11 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Other COPD
|
18.2%
2/11 • Number of events 2 • 6 months
|
27.3%
3/11 • Number of events 4 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Other Respiratory
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/11 • 6 months
|
|
Gastrointestinal disorders
Abdominal Hernia
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/11 • 6 months
|
|
Renal and urinary disorders
Elevated Blood Urea Nitrogen (BUN)
|
0.00%
0/11 • 6 months
|
9.1%
1/11 • Number of events 2 • 6 months
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/11 • 6 months
|
18.2%
2/11 • Number of events 2 • 6 months
|
|
Renal and urinary disorders
Urinary Infection
|
0.00%
0/11 • 6 months
|
9.1%
1/11 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/11 • 6 months
|
|
General disorders
Epistaxis
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/11 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/11 • 6 months
|
|
Cardiac disorders
Chest Pain
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/11 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Sprain
|
9.1%
1/11 • Number of events 1 • 6 months
|
0.00%
0/11 • 6 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/11 • 6 months
|
9.1%
1/11 • Number of events 1 • 6 months
|
Additional Information
Richard Casaburi
Harbo-UCLA Research and Education Institute
Phone: 310-22-8249
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place