Table 5.
Number (%) of subjects reporting AEs and SAEs following administration of single doses (safety population)
| Study 1 (SDDPI)
|
Study 2 (MDDPI)
|
|||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo (N=14) |
CHF6001
|
Placebo (N=9) |
CHF6001
|
|||||||||
| 20 µg (N=8) |
100 µg (N=8) |
200 µg (N=8) |
400 µg (N=7) |
800 µg (N=7) |
1,600 µg (N=7) |
2,000 µg (N=6) |
2,400 µg (N=9) |
4,000 µg (N=8) |
4,800 µg (N=8) |
|||
|
| ||||||||||||
| At least one AE | 3 (21.4) | 1 (12.5) | 0 | 3 (37.5) | 2 (28.6) | 3 (42.9) | 2 (28.6) | 0 | 2 (22.2) | 3 (33.3) | 1 (12.5) | 1 (12.5) |
| Severe AE | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (11.1) | 0 | 0 |
| At least one SAE | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| AE considered related to study medication | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (11.1) | 1 (12.5) | 0 |
| AE leading to withdrawal | 0 | 0 | 0 | 1 (12.5) | 0 | 0 | 0 | 0 | 0 | 1 (11.1) | 0 | 0 |
| AE leading to death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Note: Safety population is defined as all randomized subjects who had received at least one dose of study medication.
Abbreviations: AE, adverse event; MDDPI, study medication administered via multi-dose dry-powder inhaler; SAE, serious adverse event; SDDPI, study medication administered via single-dose dry-powder inhaler.