Table 1. Characteristics of the study population.
Oxygen (N,%) | Medical Air (N,%) | Overall (N,%) | |||||
---|---|---|---|---|---|---|---|
N | 120 | 119 | 239 | ||||
Male | 76 | 63 | 71 | 60 | 147 | 62 | |
Etiology | |||||||
COPD | 71 | 59 | 81 | 68 | 152 | 63 | |
Restrictive lung disease | 5 | 4 | 9 | 8 | 14 | 6 | |
Bronchiectasis | 4 | 3 | 3 | 2 | 7 | 3 | |
Primary pulmonary hypertension | 0 | 0 | 3 | 2 | 3 | 1 | |
Primary lung cancer | 18 | 15 | 15 | 13 | 33 | 14 | |
Known secondary lung cancer | 2 | 2 | 3 | 3 | 5 | 2 | |
Pleural effusion | 2 | 2 | 0 | 0 | 2 | 1 | |
End stage cardiomyopathy | 2 | 2 | 5 | 4 | 7 | 3 | |
Other | 16 | 13 | 0 | 0 | 16 | 7 | |
Age | Mean (SD) | 73 (11) | 74 (10) | 73 (10) | |||
Baseline morning dyspnea (Day -1; 0-10 NRS) | Mean (SD) | 4.5 (2.2) | 4. 6 (2.4) | 4.5 (2.3) | |||
Baseline evening dyspnea (Day -1; 0-10 NRS) | Mean (SD) | 4.7 (2.2) | 4.7 (2.3) | 4.7 (2.2) | |||
Baseline global QOL (Day 0; 0-10 NRS) | Mean (SD) | 6.2 (2.2) | 5.9 (2.0) | 6.0 (2.1) | |||
MRC dyspnea functional scale | |||||||
Breathless when walking at own pace* | 0 | 0 | 1 | 1 | 1 | 1 | |
Breathless when walking 100 yards | 54 | 45 | 59 | 50 | 113 | 47 | |
Breathless when dressing or undressing | 66 | 55 | 59 | 49 | 125 | 52 | |
Dyspnea Exertion Scale | |||||||
1: Able to walk at own pace on the level without getting out of breath | 11 | 9 | 9 | 8 | 20 | 9 | |
2: Becomes breathless when walking around the house or on the hospital ward on the level at own pace | 54 | 46 | 50 | 44 | 104 | 45 | |
3: Becomes breathless if moves around in bed or get out of bed | 26 | 22 | 29 | 26 | 55 | 24 | |
4: Becomes breathless when talking | 24 | 20 | 23 | 20 | 47 | 20 | |
5: Is breathless at rest | 4 | 3 | 2 | 2 | 6 | 2 | |
ECOG Performance Status | |||||||
0: Fully active, able to carry on all pre-disease performance without restriction | 0 | 0 | 1 | 1 | 1 | 0 | |
1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light of sedentary nature, e.g., light house work, office work | 40 | 34 | 29 | 26 | 69 | 30 | |
2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours | 48 | 40 | 61 | 54 | 109 | 47 | |
3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours | 31 | 26 | 22 | 19 | 53 | 23 | |
Regular oxygen previously prescribed | 56 | 48 | 59 | 50 | 115 | 48 | |
PaO2 | Mean (SD) | 77 (12) | 76 (12) | 77 (12) | |||
Range | 56-122 | 58-132 | 56-132 | ||||
PaCO2 | Mean (SD) | 39 (4) | 38 (5) | 39 (5) | |||
Range | 28-51 | 27-51 | 27-51 | ||||
Strata for randomization: | |||||||
PaO2<=70.5 | 40 | 33 | 44 | 37 | 84 | 35 | |
70.6<=PaO2<=80.5 | 37 | 31 | 38 | 32 | 75 | 31 | |
80.6<=PaO2<=90.5 | 27 | 23 | 22 | 18 | 49 | 21 | |
PaO2>=90.6 | 16 | 13 | 15 | 13 | 31 | 13 | |
Total hours of concentrator use** | Mean(SD) | 93 (36) | 98 (44) | 96 (40) |
This individual met the MRC eligibility criteria during enrollment.
NOTE: 15 hours/day, per protocol = 105 total hours