Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD III/IV, Oxygen Supply, Six-Minute-Walking-Test, Oxygen Responder
Brief summary
The aim of this study is to investigate the six-minute-walking-distance of COPD-patients with breathing oxygen in comparison to breathing normal air. Patients, who increase their walking-distance about more than 15% or 35m only because of breathing oxygen, are so-called Oxygen Responders. The study is aimed to find attributes of Oxygen Responder and to investigate, if a patient can change the respond with higher performance and endurance.
Interventions
OTHER6MWT with oxygen
2 liter per minute as continuous-flow
OTHER6MWT with medical air
2 liters as continuous-flow
Sponsors
ROX Medical, Inc.
Schön Klinik Berchtesgadener Land
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic obstructive pulmonary disease III/IV
Exclusion criteria
* Severe exacerbations in the last 4 weeks prior to begin of study (definition of exacerbation: symptoms on more than 3 days with a relevant change in drug therapy (cortisone, antibiotics)) * Severe exacerbation during rehabilitation * Cardiac insufficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Response | day 1 and day 2; day 21 and day 22 | Change in oxygen response (6-minute-walking distance on oxygen minus 6-minute-walking distance on medical air) from baseline to 3 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Saturation | day 1: minute 0 and 6 | Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air |
| Oxygen Partial Pressure (paO2) | day 1: minute 0 and 6 | change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air |
| Diffusion Capacity | day 1 and 21 | change in diffusion capacity from baseline to 3 weeks |
| Lung Function | day 1 and 21 | change in lung function from baseline to 3 weeks |
| BORG-Score | day 1: minute 0 and minute 6 | change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air |
Countries
Germany
Participant flow
Recruitment details
inpatient rehabilitation programme, recruitment directly after admission.
Participants by arm
| Arm | Count |
|---|---|
| 6MWT With Different Gas Mixtures | 127 |
| Total | 127 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | acute exacerbation | 14 |
| Overall Study | non-compliance | 2 |
Baseline characteristics
| Characteristic | 6MWT With Different Gas Mixtures |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 67 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants |
| Age Continuous | 63.7 years STANDARD_DEVIATION 8.74 |
| Forced expiratory volume in 1 second (FEV1%pred.) | 35.5 percentage of predicted value STANDARD_DEVIATION 11.5 |
| Region of Enrollment Germany | 127 participants |
| Sex: Female, Male Female | 54 Participants |
| Sex: Female, Male Male | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Oxygen Response
Change in oxygen response (6-minute-walking distance on oxygen minus 6-minute-walking distance on medical air) from baseline to 3 weeks
Time frame: day 1 and day 2; day 21 and day 22
Population: per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxygen Response | Oxygen Response | 26.9 Meter | Standard Deviation 41.9 |
Secondary
BORG-Score
change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air
Time frame: day 2: minute 0 and minute 6
Secondary
BORG-Score
change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air
Time frame: day 1: minute 0 and minute 6
Secondary
BORG-Score
change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air
Time frame: day 22: minute 0 and minute 6
Secondary
BORG-Score
change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air
Time frame: day 21: minute 0 and minute 6
Secondary
Diffusion Capacity
change in diffusion capacity from baseline to 3 weeks
Time frame: day 1 and 21
Secondary
Lung Function
change in lung function from baseline to 3 weeks
Time frame: day 1 and 21
Secondary
Oxygen Partial Pressure (paO2)
change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air
Time frame: day 2: minute 0 and 6
Secondary
Oxygen Partial Pressure (paO2)
change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air
Time frame: day 21: minute 0 and minute 6
Secondary
Oxygen Partial Pressure (paO2)
change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air
Time frame: day 1: minute 0 and 6
Secondary
Oxygen Partial Pressure (paO2)
change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air
Time frame: day 20: minute 0 and minute 6
Secondary
Oxygen Saturation
Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air
Time frame: day 2: minute 0 and 6
Secondary
Oxygen Saturation
Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air
Time frame: day 21: minute 0 and 6
Secondary
Oxygen Saturation
Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air
Time frame: day 22: minute 0 and 6
Secondary
Oxygen Saturation
Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air
Time frame: day 1: minute 0 and 6