Table 1. Baseline characteristics of participants and completion rates in a multi-site, placebo-controlled, parallel-arm study of 20 mg morphine daily for chronic breathlessness by study arm (n=284).
| Intention-to-treat—whole population | |||||
| Morphine n=145 | Placebo n=139 | ||||
| Clinico-demographic data | |||||
| Age (years) | Mean (SD) | 74.0 (9.6) | 74.5 (9.1) | ||
| Range | 44.8, 94.1 | 44.3, 89.4 | |||
| Sex n (%) | Female | 52 (35.9%) | 52 (37.4%) | ||
| Functional status (Australia-modified Karnofsky Performance Score: 0–100) | Mean (SD) | 61 (12) | 62 (10) | ||
| Range | 30, 90 | 40, 80 | |||
| Body mass index (kg/m2) | Mean (SD) | 25.2 (7.6) | 25.9 (7.0) | ||
| Range | 13.0, 66.1 | 12.3, 47.8 | |||
| Charlson Co-morbidity Index (CCI) | Mean (SD) | 3.3 (2.5) | 3.2 (2.5) | ||
| Range | 0, 12 | 1, 13 | |||
| Baseline chronic breathlessness assessments | |||||
| Primary clinician-assessed cause for chronic breathlessness n (%) | COPD | 82 (56.6%) | 82 (59.0%) | ||
| Mixed/Other | 37 (25.5%) | 35 (25.2%) | |||
| Cancer | 26 (17.9%) | 22 (15.8%) | |||
| Self-rated modified Medical Research Council (mMRC) score at baseline (0–4)* n (%) | 1 | 18 (14.1%) | 12 (10.3%) | ||
| 2 | 22 (17.2%) | 25 (21.6%) | |||
| 3 | 33 (25.8%) | 33 (28.4%) | |||
| 4 | 55 (43.0%) | 46 (39.7%) | |||
| Baseline mean (SD) breathlessness scores0–100 mm visual analogue scale (VAS) | Intensity/severity† | In the previous 24 hours | Worst | 58.5 (23.8) | 60.7 (24.9) |
| Best | 28.3 (21.3) | 30.1 (20.5) | |||
| Average | 41.2 (18.5) | 43.8 (20.6) | |||
| Now | Now | 40.9 (22.0) | 42.9 (23.1) | ||
| Affective‡ | Unpleasantness | 37.5 (22.0) | 37.4 (23.7) | ||
| Oxygen use n (%) | Yes | 87 (60.0%) | 75 (54.0%) | ||
| Completion of all 7 days of therapy in the allocated arm n (%) | 112 (77.2%) | 121 (87.1%) | |||
*
This is in contrast to clinician-rated mMRC at screening.
†
Anchored at ‘none’ and ‘worst’ possible.
‡
Anchored at ‘none’ and ‘the most unpleasant that I have ever felt.’.
COPDchronic obstructive pulmonary disease