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Review

Assessing the viability of long-acting β2-agonists in paediatric asthma patients: a pharmacokinetic/pharmacodynamic perspective

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Pages 129-136 | Received 30 Mar 2016, Accepted 06 Sep 2016, Published online: 14 Sep 2016

References

  • Condemi JJ, Goldstein S, Kalberg C, et al. The addition of salmeterol to fluticasone propionate versus increasing the dose of fluticasone propionate in patients with persistent asthma. Ann Allergy Asthma Immunol. 1999;82(4):383–389.
  • O’Byrne PM, Bisgaard H, Godard PP, et al. Budesonide/formoterol combination therapy as both maintenance and reliever medication in asthma. Am J Respir Crit Care Med. 2005;171(2):129–136.
  • Global Initiative for Asthma. Global strategy for asthma management and prevention. Revised 2015. [cited 2016 Mar 21]. Available from: http://www.ginasthma.org/
  • National Asthma Education and Prevention Program. Expert panel report 3 (EPR-3): guidelines for the diagnosis and management of asthma-summary report 2007. J Allergy Clin Immunol. 2007;120(5 Suppl):S94–S138.
  • Bisgaard H, Szefler S. Long-acting beta2 agonists and paediatric asthma. Lancet. 2006;367:286–288.
  • Zhao Y, Han S, Shang J, et al. Effectiveness of drug treatment strategies to prevent asthma exacerbations and increase symptom-free days in asthmatic children: a network meta-analysis. J Asthma. 2015;52(8):846–857.
  • Lemanske RF Jr, Mauger DT, Sorkness CA, et al. Step-up therapy for children with uncontrolled asthma receiving inhaled corticosteroids. N Engl J Med. 2010;362:975–985.
  • Ducharme FM, Ni Chroinin M, Greenstone I, et al. Addition of long-acting beta2-agonists to inhaled steroids versus higher dose inhaled steroids in adults and children with persistent asthma. Cochrane Database Syst Rev. 2010;(4):CD005533.
  • Cates CJ, Cates MJ. Regular treatment with salmeterol for chronic asthma: serious adverse events. Cochrane Database Syst Rev. 2008;(3):CD006363.
  • Cates CJ, Lasserson TJ, Jaeschke R. Regular treatment with formoterol and inhaled steroids for chronic asthma: serious adverse events. Cochrane Database Syst Rev. 2009;(2):CD006924.
  • Rodrigo GJ, Moral VP, Marcos LG, et al. Safety of regular use of long-acting beta agonists as monotherapy or added to inhaled corticosteroids in asthma. A systematic review. Pulm Pharmacol Ther. 2009;22:9–19.
  • Kramer JM. Balancing the benefits and risks of inhaled long-acting beta-agonists--the influence of values. N Engl J Med. 2009;360:1592–1595.
  • Casares-Alonso I, Cano-Garcinuño A, Blanco-Quirós A, et al. Anti-asthmatic prescription variability in children according to age. Allergol Immunopathol (Madr). 2015;43(4):383–391.
  • Anderson WC 3rd, Szefler SJ. New and future strategies to improve asthma control in children. J Allergy Clin Immunol. 2015;136(4):848–859.
  • Ginsberg G, Hattis D, Sonawane B, et al. Evaluation of child/adult pharmacokinetic differences from a database derived from the therapeutic drug literature. Toxicol Sci. 2002;66:185–200.
  • Kearns GL, Abdel-Rahman SM, Alander SW, et al. Developmental pharmacology–drug disposition, action, and therapy in infants and children. N Engl J Med. 2003;349:1157–1167.
  • Batchelor HK, Marriott JF. Paediatric pharmacokinetics: key considerations. Br J Clin Pharmacol. 2015;79:395–404.
  • Mahmood I. Prediction of drug clearance in children: a review of different methodologies. Expert Opin Drug Metab Toxicol. 2015;11:573–587.
  • Skinner AV. Neonatal pharmacology. Anaesth Intensive Care Med. 2011;12:79–84.
  • Murry DJ, Crom WR, Reddick WE, et al. Liver volume as a determinant of drug clearance in children and adolescents. Drug Metab Dispos. 1995;23:1110–1116.
  • De Wildt SN, Kearns GL, Leeder JS, et al. Cytochrome P450 3A: ontogeny and drug disposition. Clin Pharmacokinet. 1999;37:485–505.
  • Strolin Benedetti M, Whomsley R, Baltes EL. Differences in absorption, distribution, metabolism and excretion of xenobiotics between the paediatric and adult populations. Expert Opin Drug Metab Toxicol. 2005;1:447–471.
  • Strolin Benedetti M, Baltes EL. Drug metabolism and disposition in children. Fundam Clin Pharmacol. 2003;17:281–299.
  • Cazzola M, Testi R, Matera MG. Clinical pharmacokinetics of salmeterol. Clin Pharmacokinet. 2002;41(1):19–30.
  • Bartow RA, Brogden RN. Formoterol. An update of its pharmacological properties and therapeutic efficacy in the management of asthma. Drugs. 1998;55:303–322.
  • Lecaillon JB, Kaiser G, Palmisano M, et al. Pharmacokinetics and tolerability of formoterol in healthy volunteers after a single high dose of Foradil dry powder Inhalation via aerolizerTM. Eur J Clin Pharmacol. 1999;55:131–138.
  • Taburet A-M, Schmit B. Pharmacokinetic optimisation of asthma treatment. Clin Pharmacokinet. 1994;26:396–418.
  • Morgan DJ. Clinical pharmacokinetics of beta-agonists. Clin Pharmacokinet. 1990;18:270–279.
  • Brogden RN, Faulds D. Salmeterol xinafoate. A review of its pharmacological properties and therapeutic potential in reversible obstructive airways disease. Drugs. 1991;42:895–912.
  • Somers GI, Lindsay N, Lowdon BM, et al. A comparison of the expression and metabolizing activities of phase I and II enzymes in freshly isolated human lung parenchymal cells and cryopreserved human hepatocytes. Drug Metab Dispos. 2007;35:1797–1805.
  • Cazzola M, Calzetta L, Page CP, et al. Use of indacaterol for the treatment of COPD: a pharmacokinetic evaluation. Expert Opin Drug Metab Toxicol. 2014;10:129–137.
  • Harrell AW, Siederer SK, Bal J, et al. Metabolism and disposition of vilanterol, a long-acting β2-adrenoceptor agonist for inhalation use in humans. Drug Metab Dispos. 2013;41:89–100.
  • Deeks ED. Olodaterol: a review of its use in chronic obstructive pulmonary disease. Drugs. 2015;75:665–673.
  • De Cock RFW, Piana C, Krekels EHJ, et al. The role of population PK-PD modelling in paediatric clinical research. Eur J Clin Pharmacol. 2011;67(Suppl. S1):S5–S16.
  • Sammons H. Ethical issues of clinical trials in children: a European perspective. Arch Dis Child. 2009;94:474–477.
  • Wildhaber JH, Devadason SG, Eber E, et al. Aerosol delivery to wheezy infants: a comparison between a nebulizer and two small volume spacers. Pediatr Pulmonol. 1997;23:212–216.
  • Devadason SG, Everard ML, MacErlan C, et al. Lung deposition from the Turbuhaler in children with cystic fibrosis. Eur Respir. 1997;10:2023–2028.
  • Chua HL, Collis GG, Newbury AM, et al. The influence of age on aerosol deposition in children with cystic fibrosis. Eur Respir J. 1994;7:2185–2191.
  • Mallol J, Rattray S, Walker G, et al. Aerosol deposition in infants with cystic fibrosis. Pediatr Pulmonol. 1996;21:276–281.
  • Rottier BL, Rubin BK. Asthma medication delivery: mists and myths. Paediatr Respir Rev. 2013;14:112–118.
  • Kuna P, Govoni M, Lucci G, et al. Pharmacokinetics and pharmacodynamics of an extrafine fixed pMDI combination of beclometasone dipropionate/formoterol fumarate in adolescent asthma. Br J Clin Pharmacol. 2015;80(3):569–580.
  • Berg E. In vitro properties of pressurized metered dose inhalers with and without spacer devices. J Aerosol Med. 1995;8 Suppl 3:S3–S10.
  • Van Schayck CP, Donnell D. The efficacy and safety of QVAR (hydrofluoroalkane-beclomethasone diproprionate extrafine aerosol) in asthma (Part 2): clinical experience in children. Int J Clin Pract. 2004;58:786–794.
  • Agertoft L, Andersen A, Weibull E, et al. Systemic availability and pharmacokinetics of nebulised budesonide in preschool children. Arch Dis Child. 1999;80:241–247.
  • Chawes BL, Govoni M, Kreiner-Møller E, et al. Systemic exposure to inhaled beclometasone/formoterol DPI is age and body size dependent. Respir Med. 2014;108:1108–1116.
  • Oliver A, Van Buren S, Allen A, et al. Safety, tolerability, pharmacokinetics, and pharmacodynamics of vilanterol, a novel inhaled long-acting β-agonist, in children aged 5-11 years with persistent asthma: A randomized trial. Clin Pharmacol Drug Dev. 2014;3:215–221.
  • Penna AC, Dawson KP, Manglick P, et al. Systemic absorption of salbutamol following nebulizer delivery in acute asthma. Acta Pediatr. 1993;82:963–966.
  • Bonnelykke K, Jespersen JJ, Bisgaard H. Age dependent systemic exposure to inhaled salbutamol. Br J Clin Pharmacol. 2007;64:241–244.
  • Govoni M, Piccinno A, Lucci G, et al. The systemic exposure to inhaled beclometasone/formoterol pMDI with valved holding chamber is independent of age and body size. Pulm Pharmacol Ther. 2015;30:102–109.
  • Cazzola M, Page CP, Calzetta L, et al. Pharmacology and therapeutics of bronchodilators. Pharmacol Rev. 2012;64:450–504.
  • Cazzola M, Page CP, Rogliani P, et al. β2-agonist therapy in lung disease. Am J Respir Crit Care Med. 2013;187:690–696.
  • Brink C, Duncan PG, Midzenski M, et al. Response and sensitivity of female guinea-pig respiratory tissues to agonists during ontogenesis. J Pharmacol Exp Ther. 1980;215:426–433.
  • Preuss JM, Rigby PJ, Goldie RG. The influence of animal age on beta-adrenoceptor density and function in tracheal airway smooth muscle. N Schmied Arch Pharmacol. 1999;360:171–178.
  • Scarpace PJ, Abrass IB. Decreased beta-adrenergic agonist affinity and adenylate cyclase activity in senescent rat lung. J Gerontol. 1983;38:143–147.
  • Vestal RE, A Jj W, Shand DG. Reduced beta adrenoceptor sensitivity in the elderly. Clin Pharmacol Ther. 1979;26:181–185.
  • Connolly MJ, Crowley JJ, Charan NB, et al. Impaired bronchodilator response to albuterol in healthy elderly men and women. Chest. 1995;108:401–406.
  • Ullah MI, Newman GB, Saunders KB. Influence of age on response to ipratropium and salbutamol in asthma. Thorax. 1981;36:523–529.
  • Bisgaard H. Effect of long-acting β2 agonists on exacerbation rates of asthma in children. Pediatr Pulmonol. 2003;36:391–398.
  • Tal A, Simon G, Vermeulen JH, et al. Budesonide/formoterol in a single inhaler versus inhaled corticosteroids alone in the treatment of asthma. Pediatr Pulmonol. 2002;34:342–350.
  • GlaxoSmithKline Clinical Trial Register. SAM 40012 trial. [ cited 2016 Aug 15]. Available from: http://www.gsk-clinicalstudyregister.com
  • Xia Y, Kelton CM, Xue L, et al. Safety of long-acting beta agonists and inhaled corticosteroids in children and adolescents with asthma. Ther Adv Drug Saf. 2013;4:254–263.
  • Chauhan BF, Chartrand C, Ni Chroinin M, et al. Addition of long-acting beta2-agonists to inhaled corticosteroids for chronic asthma in children. Cochrane Database Syst Rev. 2015;11:CD007949.
  • Kew KM, Beggs S, Ahmad S. Stopping long-acting beta2-agonists (LABA) for children with asthma well controlled on LABA and inhaled corticosteroids. Cochrane Database Syst Rev. 2015 May 21;(5):CD011316.
  • Skoner DP. Pharmacokinetics, pharmacodynamics, and the delivery of pediatric bronchodilator therapy. J Allergy Clin Immunol. 2000;106(3 Suppl):S158–S164.
  • Pedersen S, Dubus JC, Crompton GK. The ADMIT series–issues in inhalation therapy. 5) Inhaler selection in children with asthma. Prim Care Respir J. 2010;19:209–216.
  • Wildhaber J, Devadson SG, Hayden MJ, et al. Aerosol delivery to wheezy infants; a comparison between nebulizers and two small volume spacers. Pediatr Pulmonol. 1997;23:212–216.
  • Olsson B, Borgström L, Asking L, et al. Effect of inlet throat on the correlation between measured fine particles dose and lung deposition. In: Dalby R, Byron P, Farr S, editors. Respiratory drug delivery V. Buffalo Grove (IL): Interpharm Press; 1996. p. 273–281.
  • Chawes BL, Govoni M, Piccinno A, et al. A clinical pharmacology study of fixed vs. free combination of inhaled beclometasone dipropionate and formoterol fumarate dry powder inhalers in asthmatic adolescents. Br J Clin Pharmacol. 2014;78:1169–1171.
  • Chou KJ, Cunningham SJ, Crain EF. Metered-dose inhalers with spacers vs nebulizers for pediatric asthma. Arch Pediatr Adolesc Med. 1995;149:201–205.
  • Tod M, Jullien V, Pons G. Facilitation of drug evaluation in children by population methods and modelling. Clin Pharmacokinet. 2008;47:231–243.
  • Dunne J. The European regulation on medicines for paediatric use. Paediatr Respir Rev. 2007;8:177–183.

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