• Respiratory medicine · Aug 2014

    Randomized Controlled Trial Multicenter Study

    Systemic exposure to inhaled beclometasone/formoterol DPI is age and body size dependent.

    • B L Chawes, M Govoni, E Kreiner-Møller, N H Vissing, P Poorisrisak, L Mortensen, E Nilsson, A Bisgaard, A Dossing, M Deleuran, N L Skytt, N Samandari, A Piccinno, F Sergio, G Ciurlia, G Poli, D Acerbi, D Singh, and H Bisgaard.
    • Copenhagen Prospective Studies on Asthma in Childhood, Health Sciences, University of Copenhagen & Danish Pediatric Asthma Center, Copenhagen University Hospital, Gentofte, Denmark. Electronic address: b_chawes@hotmail.com.
    • Respir Med. 2014 Aug 1; 108 (8): 1108-16.

    AimPrescription of inhaled corticosteroids to children with asthma is recommended at half the nominal dose of adults in order to reduce the risk of systemic side effects. However, there is a lack of pharmacokinetic trials supporting such dose reduction regimens. Therefore, we aimed to compare the systemic exposure to the active ingredients of a fixed dose combination of beclometasone-dipropionate (BDP) and formoterol after dry powder inhaler (DPI) administration in children, adolescents and adults.MethodsThe pharmacokinetic profiles of formoterol and beclometasone-17-monopropionate (B17MP; active metabolite of BDP) were evaluated over 8 h from two independent studies comprising children (6-11yrs, n = 27), adolescents (12-17 yrs, n = 28) and adults (≥18 yrs, n = 30) receiving a single, fixed dose of BDP/formoterol (children: 200 μg/24 μg, adolescents and adults: 400 μg/24 μg) via DPI.ResultsThe systemic exposure (AUC) for children versus adults was almost doubled for formoterol and similar for B17MP despite the halved BDP dose administered in children. In adolescents the AUC for formoterol and B17MP were approximately one third higher than in adults for both compounds. Upon normalization for the BDP/formoterol dose in the three populations the AUC and peak concentration (C(max)) correlated inversely with age and body surface area of the patients (r ≤ -0.53; p < 0.0001).ConclusionThe systemic exposure to the active ingredients of BDP/formoterol administered as DPI correlates inversely with age and body size suggesting that dry powder dosage regimens should be adjusted for age and body size to avoid high systemic drug levels in children.Copyright © 2014 Elsevier Ltd. All rights reserved.

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