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Author Chawes, B.L.K.; Piccinno, A.; Kreiner-Moller, E.; Vissing, N.H.; Poorisrisak, P.; Mortensen, L.; Nilson, E.; Bisgaard, A.; Dossing, A.; Deleuran, M.; Skytt, N.L.; Samandari, N.; Sergio, F.; Ciurlia, G.; Poli, G.; Acerbi, D.; Bisgaard, H. url  doi
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  Title Pharmacokinetic comparison of inhaled fixed combination vs. the free combination of beclomethasone and formoterol pMDIs in asthmatic children Type Journal Article
  Year (down) 2013 Publication British Journal of Clinical Pharmacology Abbreviated Journal Br J Clin Pharmacol  
  Volume 75 Issue 4 Pages 1081-1088  
  Keywords Administration, Inhalation; Anti-Asthmatic Agents/administration & dosage/adverse effects/*pharmacokinetics/pharmacology; Asthma/blood/*drug therapy/urine; Beclomethasone/administration & dosage/adverse effects/*pharmacokinetics/pharmacology; Biological Availability; Child; Child, Preschool; Drug Combinations; Drug Therapy, Combination; Ethanolamines/administration & dosage/adverse effects/*pharmacokinetics/pharmacology; Female; Formoterol Fumarate; Glucose/metabolism; Heart Rate/drug effects; Humans; Hydrocortisone/urine; Male; Metered Dose Inhalers; Peak Expiratory Flow Rate/drug effects; Potassium/blood  
  Abstract AIM: The fixed combination of beclomethasone (BDP) and formoterol pressurized metered dose inhaler (pMDI) (Foster(R), Chiesi Farmaceutici) is being developed in the lower strength (BDP/formoterol: 50/6 mug) to provide an appropriate dosage for children with asthma. The aim of this work was to investigate the systemic bioavailability of beclomethasone-17-monoproprionate (B17MP, the active metabolite of BDP) and formoterol after single inhalation of Foster(R) pMDI 50/6 mug vs. the free combination of BDP and formoterol pMDIs in asthmatic children. METHODS: Children aged 5-11 years old inhaled BDP 200 mug and formoterol 24 mug as fixed vs. free combination in an open label, randomized, two way crossover single dose study. Blood was collected pre-dose up to 8 h post-dose for pharmacokinetic evaluation (AUC(0,t), AUC(0,infinity), AUC(0,0.5 h, Cmax , tmax , t1/2 ). Pharmacodynamics included heart rate, plasma potassium, urinary glucose and cortisol excretion. Peak expiratory flow and adverse events were monitored. RESULTS: Twenty subjects were evaluable. The systemic exposure of B17MP and formoterol administered as fixed combination did not exceed the free combination: B17MP AUC(0,t) (pg ml(-1) h) ratio test : reference (90% CI), 0.81 (0.697, 0.948) and formoterol AUC(0,t) (pg ml(-1) h) ratio test : reference 0.97 (0.85, 1.10). All pharmacokinetic and pharmacodynamic end points showed non-superiority in favour of the test drug. One adverse event (vertigo) occurred but was not considered treatment-related. CONCLUSION: BDP and formoterol pharmacokinetic and pharmacodynamic effects are non-superior after administration of the two actives as fixed vs. the free combination in 5-11-year-old asthmatic children.  
  Address Copenhagen University Hospital, Copenhagen Prospective Studies on Asthma in Childhood, Health Sciences, University of Copenhagen & Danish Pediatric Asthma Center, Gentofte, Denmark  
  Corporate Author Thesis  
  Impact Factor 03,878 First Author Chawes, B.L.K. Editor  
  Language English Summary Language Original Title  
  Series Editor Series Title Abbreviated Series Title  
  Series Volume Series Issue Senior Author Bisgaard, H.  
  ISSN 0306-5251 ISBN Medium  
  Area Expedition Conference  
  Notes PMID:22978252; PMCID:PMC3612726 Approved no  
  Call Number Serial 91  
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