Table 1.
Demographic characteristics (safety population)
| Study 1 (SDDPI)
|
Study 2 (MDDPI)
|
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1
|
Part 2
|
Part 1
|
Part 2
|
||||||||||
| Overall (N=20) |
Placebo (N=13) |
CHF6001
|
Overall (N=12) |
Placebo (N=9) |
CHF6001
|
||||||||
| 100 µg OD (N=8) |
300 µg OD (N=8) |
600 µg OD (N=9) |
1,200 µg OD (N=9) |
1,600 µg OD (N=7) |
1,200 µg BID (N=9) |
2,000 µg BID (N=9) |
2,400 µg BID (N=9) |
||||||
|
| |||||||||||||
| Age, years | 35.5 (9.8) | 33.2 (10.8) | 42.5 (10.2) | 29.5 (10.3) | 29.8 (7.4) | 32.4 (11.8) | 33.4 (9.6) | 36.4 (13.3) | 31.1 (11.0) | 41.4 (12.6) | 31.1 (10.2) | 35.8 (7.3) | |
| Height, cm | 180.1 (9.2) | 175.5 (7.6) | 174.0 (7.8) | 178.6 (3.5) | 179.9 (9.7) | 179.7 (9.2) | 177.9 (6.8) | 174.4 (10.9) | 175.9 (8.2) | 171.1 (7.4) | 177.7 (10.2) | 177.3 (7.9) | |
| BMI, kg/m2 | 26.1 (3.0) | 25.6 (2.6) | 26.6 (2.3) | 25.1 (3.2) | 24.4 (3.3) | 25.1 (3.9) | 25.8 (2.5) | 25.6 (4.3) | 23.5 (2.4) | 27.3 (2.7) | 24.7 (4.0) | 27.2 (2.7) | |
| Race, n (%) | |||||||||||||
| Caucasian | 20 (100) | 13 (100) | 8 (100) | 8 (100) | 9 (100) | 9 (100) | 7 (100) | 12 (100) | 8 (88.9) | 9 (100) | 9 (100) | 9 (100) | |
| Othera | – | – | – | – | – | – | – | – | 1 (11.1) | – | – | – | |
| Sex, n (%) | |||||||||||||
| Male | 20 (100) | 13 (100) | 8 (100) | 8 (100) | 9 (100) | 9 (100) | 7 (100) | 7 (58.3) | 7 (77.8) | 6 (66.7) | 7 (77.8) | 9 (100) | |
| Female | – | – | – | – | – | – | – | 5 (41.7) | 2 (22.2) | 3 (33.3) | 2 (22.2) | – | |
Notes: Data are mean (SD) unless specified otherwise.
a
Mixed race (black and Caucasian). Safety population is defined as all randomized subjects who had received at least one dose of study medication.
Abbreviations: BID, twice daily; BMI, body mass index; MDDPI, study medication administered via multi-dose dry-powder inhaler; OD, once daily; SDDPI, study medication administered via single-dose dry-powder inhaler.