The conduct of this clinical trial is aimed at determining the most suitable dose regimen for children in different age groups, and secondarily to assess the safety and tolerability of bilastine in this paediatric population subset.
The objective of this study is to assess the pharmacokinetics of bilastine in children (aged 2 to \<12 years) with allergic rhinoconjunctivitis (seasonal allergic rhinitis \[SAR\] and/or perennial allergic rhinitis \[PAR\]) or chronic urticaria (CU) in order to ascertain that the systemic exposure attained with a dose of 10 mg/QD or lower is comparable to that achieved in adults and adolescents administered with a dose of 20 mg/QD. Additional objectives are to describe the safety and tolerability of a repeated administration of bilastine in children with AR or CU.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
10 mg/qd/ 7 days.Oral dispersible tablets
Royal Children's Hospital
Parkville, Victoria, Australia
Princess Margaret Hospital for Children
Subiaco, Western Australia, Australia
Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie
Berlin, Germany
Klinikum der Johann-Wolfgang-Goethe-Universität Frankfurt
The primary objective is to assess the pharmacokinetics of bilastine in children (aged 2 to <12 years) with allergic rhinoconjunctivitis (seasonal allergic rhinitis and/or perennial allergic rhinitis [SAR/PAR]) or chronic urticaria (CU)
Determination of plasma concentrations versus time (between 1 and 6 samples per subject at various time intervals after dosing according to an optimised sampling protocol) in order to perform a population pharmacokinetic analysis. For Group A, samples of venous blood will be just prior to dose administration, and at 0.25, 0.5, 0.8, 1.0, 1.2, 1.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, and 24.0 hours after dose administration. For Group B samples of venous blood will be just prior to dose administration, and at 0.25, 0.5, 1.0, 1.5, 3.0, 6.0, 8.0, 10.0, and 12.0 hours after dose administration.
Time frame: 1 day (visit 3, Day 7)
The secondary objectives are to describe the safety and tolerability of a repeated administration of bilastine in the aforementioned paediatric subset with allergic rhinoconjunctivitis (SAR/PAR) or chronic urticaria (CU).
Safety will be assessed during the study by monitoring adverse events (AEs), clinical laboratory test results (urinalysis, blood chemistry, and haematology), vital signs (including blood pressure, respiration, temperature, and heart rate, supine and standing), electrocardiogram (ECG) results, and abnormal findings upon physical examination.
Time frame: 5 weeks
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Franfurt, Germany
Universitäts-Hautklinik
Kiel, Germany
Karolinska University Hospital. Astrid Lindgren's Hospital
Stockholm, Sweden
Children's Hospital at Uppsala University Hospital
Uppsala, Sweden