Table 5 Change in clinical safety parameters from pre-dose values following treatment: safety population
Placebo N = 59 | Salbutamol 400 μg N = 58 | Abediterol 0.313 μg N = 60 | Abediterol 0.625 μg N = 60 | Abediterol 1.25 μg N = 60 | Abediterol 2.5 μg N = 61 | |
|---|---|---|---|---|---|---|
Serum glucose (mmol/L) | ||||||
4 hours post-dose | -0.37 (0.56) | -0.24 (0.55) | -0.19 (0.71) | -0.27 (0.70) | -0.16 (0.94) | -0.23 (0.74) |
24 hours post-dose | 0.01 (0.38) | 0.00 (0.33) | 0.13 (0.51) | 0.06 (0.62) | 0.11 (0.45) | 0.15 (0.59) |
Serum potassium (mmol/L) | ||||||
4 hours post-dose | -0.01 (0.36) | -0.09 (0.38) | -0.01 (0.35) | 0.10 (0.37) | 0.02 (0.36) | -0.04 (0.35) |
24 hours post-dose | -0.02 (0.37) | 0.04 (0.34) | 0.05 (0.33) | 0.15 (0.32) | 0.04 (0.28) | 0.05 (0.38) |
Heart rate (bpm) | ||||||
0.75 h post-dose | -0.6 (9.1) | 2.0 (10.1) | -0.7 (6.1) | -0.8 (7.5) | -1.5 (9.0) | -0.8 (6.2) |
2 h post-dose | -3.4 (8.7) | -1.0 (8.0) | -2.0 (6.6) | -3.4 (8.1) | -4.3 (8.4) | -3.2 (6.7) |
6 h post-dose | 5.1 (10.2) | 7.2 (7.7) | 6.2 (7.1) | 6.2 (8.0) | 6.4 (9.8) | 5.3 (7.2) |
24 h post-dose | -2.1 (9.8) | -1.9 (8.0) | -1.6 (6.7) | -0.8 (8.4) | -0.9 (8.7) | -0.6 (7.6) |