Prednisolon in children with airway disease

Pharmacokinetics of prednisolone in children with airway disease -The POP child - POP child

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003590-33-DK

Enrollment

Registered

2017-09-14

Start date

2017-11-24

Completion date

Unknown

Last updated

2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, pharmacokinetics MedDRA version: 20.0 Level: LLT Classification code 10006457 Term: Bronchitis asthmatic System Organ Class: 100000004855 MedDRA version: 21.0 Level: LLT Classification code 10003561 Term: Asthma, unspecified System Organ Class: 100000004855 MedDRA version: 21.1 Level: LLT Classification code 10049200 Term: Asthmatic wheezing System Organ Class: 100000004855

Interventions

Trade Name: Prednisolon DAK Pharmaceutical Form: CAS Number: 50-24-8 Other descriptive name: PREDNISOLONE Concentration unit: mg milligram(s) Concentration type: range Concentration number: 2.5-25 P

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Children from 6 month to 11 years of age • Admitted to the paediatric department or assessed in paediatric emergency department with asthmatic bronchitis or asthma • Intended prednisolone treatment • Informed written consent from both parents or legal guardian, Informed Consents must be approved by the Danish Ethical Committee Are the trial subjects under 18? yes Number of subjects for this age range: 48 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • The responsible clinicians finds the patient unsuitable for trial • Hypersensitivity towards prednisolone • Menarche or testis volume > 4 ml (evaluated in children above 7 years of age) • Inability to swallow tablets in the control group • Non compliance with the given formulations after three attempts

Design outcomes

Primary

Measure	Time frame
Main Objective: To examine the pharmacokinetics of different prednisolone formulations i.e. crushed tablets and oral solutions to characterise its bioavailability relative to standard whole tablets (controls).Herein compare the AUC, Cmax and Tmax;Secondary Objective: • Tolerability of different formulations assessed by number of doses swallowed, patient preferences and vomiting. • Adverse events • Modified Pulmonary Index Score (MPIS) and Paediatric Early Warning Score (PEWS) • Validation of the saliva samples by using plasma samples;Primary end point(s): Concentration-time data on prednisolone concentration measured in saliva to determine AUC, Tmax and Cmax. ;Timepoint(s) of evaluation of this end point: Every patient is randomized to one of two time schedules for saliva sampling: T0, T0.5, T1.5, T2.5, T3.5, T7, T11 T0, T1, T2, T3, T4, T8, T12	—

Measure

Time frame

Main Objective: To examine the pharmacokinetics of different prednisolone formulations i.e. crushed tablets and oral solutions to characterise its bioavailability relative to standard whole tablets (controls).Herein compare the AUC, Cmax and Tmax;Secondary Objective: • Tolerability of different formulations assessed by number of doses swallowed, patient preferences and vomiting. • Adverse events • Modified Pulmonary Index Score (MPIS) and Paediatric Early Warning Score (PEWS) • Validation of the saliva samples by using plasma samples;Primary end point(s): Concentration-time data on prednisolone concentration measured in saliva to determine AUC, Tmax and Cmax. ;Timepoint(s) of evaluation of this end point: Every patient is randomized to one of two time schedules for saliva sampling: T0, T0.5, T1.5, T2.5, T3.5, T7, T11 T0, T1, T2, T3, T4, T8, T12

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Secondary

Measure	Time frame
Secondary end point(s): • Tolerability of different formulations measured by the Wong-Baker FACES scale • Adverse events • MPIS and PEWS score at administration time for dose 1 and 2 • Concentration-time data on prednisolone concentration measured in plasma to determine AUC, Tmax and Cmax ;Timepoint(s) of evaluation of this end point: Tolerability is evaluated at each dose. Adverse events, MPIS and PEWS score are evaluated at baseline and at each dose. Plasma samples are only obtained if an intravenous access already exists, sampling time will follow the same schedule as saliva sampling.	—

Measure

Time frame

Secondary end point(s): • Tolerability of different formulations measured by the Wong-Baker FACES scale • Adverse events • MPIS and PEWS score at administration time for dose 1 and 2 • Concentration-time data on prednisolone concentration measured in plasma to determine AUC, Tmax and Cmax ;Timepoint(s) of evaluation of this end point: Tolerability is evaluated at each dose. Adverse events, MPIS and PEWS score are evaluated at baseline and at each dose. Plasma samples are only obtained if an intravenous access already exists, sampling time will follow the same schedule as saliva sampling.

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Countries

Denmark

Contacts

Public ContactSissel Haslund-Krog

Bispebjerg University Hospital

sissel.sundell.haslund-krog.01@regionh.dk004538635806

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 20, 2026