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Author Govoni, M.; Piccinno, A.; Lucci, G.; Poli, G.; Acerbi, D.; Baronio, R.; Singh, D.; Kuna, P.; Chawes, B.L.K.; Bisgaard, H. url  doi
  Title The systemic exposure to inhaled beclometasone/formoterol pMDI with valved holding chamber is independent of age and body size Type Journal Article
  Year (down) 2015 Publication Pulmonary Pharmacology & Therapeutics Abbreviated Journal Pulm Pharmacol Ther  
  Volume 30 Issue Pages 102-109  
  Keywords Administration, Inhalation; Adolescent; Adult; Age Factors; Aged; Anti-Asthmatic Agents/administration & dosage/*pharmacokinetics; Asthma/*drug therapy; Beclomethasone/administration & dosage/*pharmacokinetics; Child; Dose-Response Relationship, Drug; Drug Combinations; Ethanolamines/administration & dosage/*pharmacokinetics; Female; Formoterol Fumarate; Humans; Male; Metered Dose Inhalers; Middle Aged; Young Adult; Adolescents; Adults; Asthma; Beclometasone; Children; Formoterol  
  Abstract BACKGROUND: Asthma guidelines recommend prescription of inhaled corticosteroids at a reduced dosage in children compared to older patients in order to minimize the systemic exposure and risk of unwanted side effects. In children, pressurized metered dose inhalers (pMDI) are recommended in combination with a valved holding chamber (VHC) to overcome the problem of coordinating inhalation with actuation. However, the influence of age and body size on the systemic exposure of drugs to be administered via a pMDI with VHC is still not fully elucidated. Therefore, we aimed to compare the systemic exposure to the active ingredients of a fixed combination of beclometasone-dipropionate/formoterol-fumarate administered via pMDI with VHC in children, adolescents and adults. METHODS: The pharmacokinetics of formoterol and beclometasone-17-monopropionate (active metabolite of beclometasone-dipropionate) was evaluated over 8 h from three studies, each performed in a different age and body size group. Children (7-11 years, n = 20), adolescents (12-17 years, n = 29) and adults (>/=18 years, n = 24) received a single dose of beclometasone/formoterol (children: 200 mug/24 mug, adolescents and adults: 400 mug/24 mug) via pMDI with AeroChamber Plus. RESULTS: The systemic exposure in children in comparison to adolescents was equivalent for formoterol while it was halved for beclometasone-17-monopropionate in accordance with the halved dose of beclometasone administered in children (90% CIs within 0.8-1.25 for formoterol and 0.4-0.625 for beclometasone-17-monopropionate). The systemic exposure to beclometasone-17-monopropionate and formoterol was equivalent between adolescents and adults. CONCLUSIONS: The systemic exposure to the active ingredients of a fixed dose combination of beclometasone/formoterol administered via pMDI with AeroChamber Plus correlates with the nominal dose independently of patient age and body size. Thus, dose reduction in relation to age when using a pMDI with VHC may be unnecessary for reducing the systemic exposure in children.  
  Address Copenhagen Prospective Studies on Asthma in Childhood, Health Sciences, University of Copenhagen & Danish Pediatric Asthma Center, Copenhagen University Hospital, Gentofte, Denmark  
  Corporate Author Thesis  
  Impact Factor 02,937 First Author Govoni, M. Editor  
  Language English Summary Language Original Title  
  Series Editor Series Title Abbreviated Series Title  
  Series Volume Series Issue Senior Author Bisgaard, H.  
  ISSN 1094-5539 ISBN Medium  
  Area Expedition Conference  
  Notes PMID:24746942 Approved no  
  Call Number Serial 41  
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