Prednisolon in children with airway disease

Phase 1

• Conditions: Asthma, pharmacokinetics; MedDRA version: 20.0Level: LLTClassification code 10006457Term: Bronchitis asthmaticSystem Organ Class: 100000004855; MedDRA version: 21.0Level: LLTClassification code 10003561Term: Asthma, unspecifiedSystem Organ Class: 100000004855; MedDRA version: 21.1Level: LLTClassification code 10049200Term: Asthmatic wheezingSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2017-003590-33-DK
• Lead Sponsor: Bispebjerg University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-14
• Last Update Posted: 30 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>• Adverse events<br>• Modified Pulmonary Index Score (MPIS) and Paediatric Early Warning Score (PEWS) <br>• 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:<br>T0, T0.5, T1.5, T2.5, T3.5, T7, T11<br>T0, T1, T2, T3, T4, T8, T12

Secondary Outcome Measures

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