Patient baseline demographics and concomitant drug use: treated set
| Placebo twice daily | BI 20 μg twice daily | BI 50 μg twice daily | BI 100 μg twice daily | BI 200 μg twice daily | |
| Patients, n (%) | 18 (100.0) | 6 (100.0) | 5 (100.0) | 5 (100.0) | 18 (100.0) |
| Gender, n (%) | |||||
| Male | 16 (88.9) | 5 (83.3) | 2 (40.0) | 4 (80.0) | 15 (83.3) |
| Female | 2 (11.1) | 1 (16.7) | 3 (60.0) | 1 (20.0) | 3 (16.7) |
| Race, n (%) | |||||
| Asian | 1 (5.6) | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 1 (20.0) | 0 |
| White | 17 (94.4) | 6 (100.0) | 5 (100.0) | 4 (80.0) | 18 (100.0) |
| Region, n (%) | |||||
| North America | 3 (16.7) | 2 (33.3) | 0 | 2 (40.0) | 4 (22.2) |
| Europe | 15 (83.3) | 4 (66.7) | 5 (100.0) | 3 (60.0) | 14 (77.8) |
| Age, years | |||||
| Mean±sd | 29.3±10.1 | 26.8±5.8 | 31.2±8.6 | 36.8±4.2 | 33.4±10.2 |
| Range (min to max) | 18–48 | 21–34 | 25–42 | 32–42 | 22–50 |
| Height, cm | |||||
| Mean±sd | 175.6±10.4 | 173.8±7.9 | 165.0±11.2 | 171.2±12.4 | 171.9±9.5 |
| Range (min to max) | 148–197 | 165–184 | 153–177 | 155–187 | 154–189 |
| Weight, kg | |||||
| Mean±sd | 68.72±12.17 | 73.35±12.18 | 60.92±9.71 | 66.76±9.93 | 65.95±9.06 |
| Range (min to max) | 50.8–90.0 | 53.0–90.0 | 50.1–74.0 | 55.3–80.1 | 46.0–87.8 |
| BMI, kg·m−2 | |||||
| Mean±sd | 22.19±2.55 | 24.15±2.71 | 22.42±3.20 | 22.74±1.94 | 22.37±3.08 |
| Range (min to max) | 17.0–26.9 | 19.5–26.8 | 18.3–26.3 | 20.8–25.4 | 17.2–30.0 |
| CFTR modulator, n (%) | |||||
| No | 11 (61.1) | 3 (50.0) | 3 (60.0) | 5 (100.0) | 11 (61.1) |
| Yes | 7 (38.9) | 3 (50.0) | 2 (40.0) | 0 | 7 (38.9) |
| Highly effective | 1 (5.6) | 2 (33.3) | 0 | 0 | 2 (11.1) |
| Ivacaftor | 1 (5.6) | 0 | 0 | 0 | 0 |
| Elexacaftor/ivacaftor/tezacaftor | 0 | 2 (33.3) | 0 | 0 | 2 (11.1) |
| Not highly effective | 6 (33.3) | 1 (16.7) | 2 (40.0) | 0 | 5 (27.8) |
| Ivacaftor/tezacaftor | 3 (16.7) | 0 | 2 (40.0) | 0 | 2 (11.1) |
| Ivacaftor/lumacaftor | 3 (16.7) | 1 (16.7) | 0 | 0 | 3 (16.7) |
| Hypertonic saline solution, n (%) | |||||
| No | 5 (27.8) | 1 (16.7) | 1 (20.0) | 2 (40.0) | 4 (22.2) |
| Yes | 13 (72.2) | 5 (83.3) | 4 (80.0) | 3 (60.0) | 14 (77.8) |
| Dornase alfa, n (%) | |||||
| No | 5 (27.8) | 2 (33.3) | 2 (40.0) | 3 (60.0) | 7 (38.9) |
| Yes | 13 (72.2) | 4 (66.7) | 3 (60.0) | 2 (40.0) | 11 (61.1) |
| Mannitol, n (%) | |||||
| No | 18 (100.0) | 6 (100.0) | 4 (80.0) | 3 (60.0) | 18 (100.0) |
| Yes | 0 | 0 | 1 (20.0) | 2 (40.0) | 0 |
| Inhaled mucolytic therapy, n (%) | |||||
| No | 5 (27.8) | 1 (16.7) | 1 (20.0) | 1 (20.0) | 4 (22.2) |
| Yes | 13 (72.2) | 5 (83.3) | 4 (80.0) | 4 (80.0) | 14 (77.8) |
| Inhaled antibiotics, n (%) | |||||
| No | 11 (61.1) | 2 (33.3) | 2 (40.0) | 2 (40.0) | 9 (50.0) |
| Yes | 7 (38.9) | 4 (66.7) | 3 (60.0) | 3 (60.0) | 9 (50.0) |
| Inhaled bronchodilators, n (%) | |||||
| No | 2 (11.1) | 0 | 0 | 0 | 2 (11.1) |
| Yes | 16 (88.9) | 6 (100.0) | 5 (100.0) | 5 (100.0) | 16 (88.9) |
| Inhaled corticosteroids, n (%) | |||||
| No | 5 (27.8) | 3 (50.0) | 0 | 2 (40.0) | 6 (33.3) |
| Yes | 13 (72.2) | 3 (50.0) | 5 (100.0) | 3 (60.0) | 12 (66.7) |
BI: BI 1265162; min: minimum; max: maximum; BMI: body mass index; CFTR: cystic fibrosis transmembrane conductance regulator.