Neonatal simulations of HFA-BDP and CFC-BDP delivery through an endotracheal tube using the Neonatal Chamber-Ventilator System or the Neonatal Chamber (simulations 1–3) and using the Neonatal Chamber and face mask without and with manual ventilation assistance (simulations 4 and 5)
| Formulation | Simulation 1 | Simulation 2 | Simulation 3 | Simulation 4 | Simulation 5 |
|---|---|---|---|---|---|
| Dose delivered is expressed as mean (SD) total emitted dose (TED) (μg) and efficiency (TED/label claim dose) (%). Three actuations/measurement; 5 measurements per holding chamber × 3 holding chambers per simulation = 15 samples per simulation. Simulation 1, Mechanical ventilation, 40% relative humidity (NCVS/ET); simulation 2, mechanical ventilation, 100% relative humidity (NCVS/ET); simulation 3, manual ventilation (NC/ET); simulation 4, no manual ventilation assistance (NC/face mask); simulation 5, manual ventilation assistance (NC/face mask). | |||||
| *Simulation 1 and 2 v 3, p<0.001; 4 v 5, p<0.001. | |||||
| **Simulation 1 v 3, p = 0.003; 2 v 3, p<0.001; 4 v 5, p<0.001. | |||||
| HFA-BDP, Hydrofluoroalkane-beclomethasone; CFC-BDP, chlorofluorocarbon-beclomethasone; ET, endotracheal tube; NCVS, Neonatal Chamber-Ventilator System; NC, Neonatal Chamber. | |||||
| HFA-BDP* | 4.4 (0.7) (8.8%) | 1.5 (0.2) (3.0%) | 6.5 (0.6) (13.0%) | 4.1 (1.6) (8.2%) | 26.6 (3.1) (53.2%) |
| CFC-BDP** | 0.4 (0.3) (0.8%) | 0.02 (0.08) (0.04%) | 1.3 (0.5) (2.6%) | 2.3 (0.7) (4.6%) | 21.6 (4.3) (43.2%) |
| p Value | <0.0001 | <0.0001 | <0.0001 | 0.0007 | 0.0011 |