Table 1

Primary and secondary objectives and outcomes in the POP child trial

Objectives and outcomes
Primary objectivePrimary outcome
To investigate the bioequivalence of different prednisolone formulations, that is, crushed tablets, oral solution and orodipersible tablets to characterise their bioequivalence compared with standard whole tablets (controls). Herein compare the AUC, Cmax and Tmax.Concentration time data on prednisolone concentration measured in saliva to determine AUC, Tmax and Cmax.
Secondary objectiveSecondary outcome

  1. Acceptability of different formulations assessed by patient preferences and number of attempts

  2. Adverse events.

  3. Modified Pulmonary Index Score (MPIS) and Paediatric Early Warning Score (PEWS).

  4. Validation of the saliva samples using plasma samples.

  1. Acceptability of different formulations measured by a modified Wong-Baker face scale (see figure 2).

  2. Adverse events registration.

  3. MPIS and PEWS score at administration time for doses 1 and 2.

  4. Concentration-time data on prednisolone concentration measured in plasma to determine AUC, Tmax and Cmax

  • AUC, area under the concentration time curve.