Table 6.
Statistical analysis of pharmacodynamic parameters in adolescents - plasma potassium, plasma glucose, pulse rate and forced expiratory volume in 1 s (FEV1)
| BDP/FF pMDI vs.BDP pMDI+FF pMDI | BDP/FF pMDI with VHC vs.BDP pMDI+FF pMDI | BDP/FF pMDI with VHC vs.BDP/FF pMDI | |
|---|---|---|---|
| Plasma potassium | PE (95% CI) | PE (95% CI) | PE (95% CI) |
| Cmin | 1.00 (0.98, 1.02) | 0.99 (0.97, 1.02) | 0.99 (0.97, 1.02) |
| AUC(0,t) | 1.00 (0.97, 1.03) | 1.00 (0.97, 1.02) | 1.00 (0.97, 1.02) |
| Plasma glucose | PE (95% CI) | PE (95% CI) | PE (95% CI) |
| Cmax | 1.00 (0.94, 1.07) | 1.02 (0.95, 1.09) | 1.02 (0.95, 1.09) |
| AUC(0,t) | 0.99 (0.95, 1.03) | 1.01 (0.98, 1.05) | 1.02 (0.99, 1.07) |
| AUC(0,2 h) | 0.99 (0.96, 1.03) | 1.00 (0.97, 1.03) | 1.01 (0.98, 1.04) |
| Pulse rate | PE (95% CI) | PE (95% CI) | PE (95% CI) |
| AUC(0,t)/8 h | 1.01 (0.97, 1.06) | 1.02 (0.98, 1.07) | 1.01 (0.97, 1.05) |
| FEV1 | PE (95% CI) | PE (95% CI) | PE (95% CI) |
| AUC(0,t)/8 h | 0.99 (0.97, 1.02) | 0.98 (0.96, 1.01) | 0.99 (0.96, 1.02) |
| Peak FEV1 | 0.98 (0.95, 1.01) | 0.98 (0.95, 1.01) | 1.00 (0.97, 1.03) |
PE, Point estimate calculated as ratio of the adjusted geometric means for the different PD parameters between treatments