Table 1. Baseline patient characteristics.
| FBT N=9 (%)a | Placebo N=11 (%)a | All patients N=20 (%)a | |
|---|---|---|---|
| Average age (range) | 52 (31-67) | 57 (45-72) | 55 (31-72) |
| Female sex | 6 (66.7) | 6 (54.5) | 12 (60) |
| Race | |||
| Caucasian | 7 (77.8) | 6 (54.5) | 13 (65) |
| Black | 2 (22.2) | 3 (27.3) | 5 (25) |
| Hispanic | 0 | 2 (18.2) | 2 (10) |
| Education | |||
| High school or less | 7 () | 9 () | 16 () |
| College | 0 | 2 (18.2) | 2 (10) |
| Advanced degree | 2 (22.2) | 0 | 2 (10) |
| Cancer type | |||
| Breast | 1 (11.1) | 2 (18.2) | 3 (15) |
| Gastrointestinal | 2 (22.2) | 1 (9.1) | 3 (15) |
| Genitourinary | 2 (22.2) | 1 (9.1) | 3 (15) |
| Gynecologic | 0 | 1 (9.1) | 1 (5) |
| Lung | 3 (33.3) | 5 (45.5) | 8 (40) |
| Others | 1 (11.1) | 1 (9.1) | 2 (10) |
| Cancer stage | |||
| Metastatic/recurrent | 9 (100) | 10 (91) | 18 (90) |
| Locally advanced | 0 | 1 (9.1) | 1 (5) |
| Average dyspnea NRS during breakthrough episodes over the last week, mean (SD) | 4.8 (1.5) | 5.5 (1.9) | 5.2 (1.7) |
| Co-morbidities | |||
| COPD | 2 (22.2) | 1 (9.1) | 3 (15) |
| Heart failure | 0 | 1 (9.1) | 1 (5) |
| Asthma | 1 (11.1) | 0 | 1 (5) |
| Bronchiectasis | 0 | 0 | 0 |
| Concurrent therapies (Scheduled) | |||
| Opioids | 9 (100) | 11 (100) | 20 (100) |
| Bronchodilators | 1 (11.1) | 1 (9.1) | 2 (10) |
| Steroids | 3 (33.3) | 1 (9.1) | 4 (20) |
| Supplemental oxygen | 0 | 0 | 0 |
| Bedside spirometry measures | |||
| FEV1 | 2 (1) | 1.5 (0.8) | 1.7 (0.9) |
| FEV1 % predicted | 66.4 (27.9) | 50.2 (23.9) | 57.9 (26.5) |
| FVC | 2.8 (1) | 2 (0.8) | 2.4 (1.0) |
| FVC % predicted | 73.3 (23.8) | 55.4 (20.2) | 63.9 (23.3) |
| FEV1 / FVC ratio (%) | 83.9 (16.9) | 90.7 (28.2) | 87.3 (22.8) |
| Morphine equivalent daily doses, median (interquartile range) in mg | 118 (85, 120) | 100 (70, 110) | 103 (73, 120) |
| Karnofsky performance status, mean (SD) | 72.2 (6.7) | 70 (8.9) | 71 (7.9) |
| Morphine equivalent daily dose (mg) | |||
| 60-65 | 0 | 2 (18) | 2 (10) |
| 66-130 | 9 (100) | 9 (82) | 18 (90) |
Abbreviations: COPD, chronic obstructive pulmonary disease; NRS, numeric rating scale; SD, standard deviation
a
unless otherwise specified