Introduction One in three Danish children under 3 years of age experience asthma-like symptoms, and one-third will later be diagnosed with asthma. Oral prednisolone is used in various formulations to treat acute asthma. However, the potential differences in bioequivalence between these formulations have never been examined in children despite interchangeable use in clinical practice.
Methods and analysis An open-label, randomised, two-treatment cross-over trial investigating the bioequivalence of different prednisolone formulations in children with airway disease.
The included patients (6 months–11 years of age) are admitted to the Department of Paediatric and Adolescent Medicine Nordsjællands University Hospital, Hillerød, with asthma or asthma-like symptoms.
The primary objective is to assess the bioequivalence between different prednisolone formulations herein area under the concentration time curve, Cmax and Tmax using saliva samples. The secondary objectives are to evaluate tolerability (five-point face scale), adverse events and severity of the disease. If the patient has an intravenous access for other purposes, the saliva samples will be validated with plasma samples.
A total of 66 evaluable patients are needed according to European Medicines Agency Guideline on bioequivalence.
Ethics and dissemination Traditional pharmacokinetic trials are burdensome due to the extent of blood samples necessary to capture the time-dependant drug profile. Saliva sampling is far more acceptable for paediatric patients. In addition, this trial adheres to standard dosing strategies. No additional venepunctures are performed, and no additional prednisolone doses are administered.
Guidelines for paediatric bioequivalence trials are warranted.
Trial registration number The Danish Medicines Agency EudraCT: 2017-003590-33, The Ethics Committee case no: H-17027252, and the Danish Data Protection Agency: BFH-2017–103, I-Suite no.: 05935.
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Contributors HH, SSH-K and IMJ were involved in the conception and design of the study. HH, SSH-K and IMJ wrote the protocol and applied for all permissions and funding. All authors were involved in preparing the study sites, acquisition of data and analysis, in writing the protocol article and in its revision prior to submission.
Funding The salary to the PhD student is covered by Department of Clinical Pharmacology and the Danish Regions. Costs for trial medicine, project staff and analysis of saliva samples are covered by the A.P. Møller Foundation, Captain Lieutenant Harald Jensen and Wife Foundation, The Danish Medical Research Grant and Aase and Ejnar Danielsens Foundation.
Competing interests None declared.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement The article reports a protocol for an ongoing trial. Therefore, no trial data are available yet. All data relevant to the study are included in the article or can be proqured from the authors upon requst.
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