Bioavailability of inhaled fluticasone propionate via chambers/masks in young children

European Respiratory Journal

Volumn 39, Issue 1, 2012, Pages 97-103

  Blake, K ^a   Mehta, R ^d   Spencer, T ^e   Kunka, R L ^d   Hendeles, L ^b,c  

^a NEMOURS CHILDREN S CLINIC   (United States)

^b UNIVERSITY OF FLORIDA HEALTH   (United States)

^c UNIVERSITY OF FLORIDA COLLEGE OF MEDICINE   (United States)

^d GLAXOSMITHKLINE   (United States)

^e BOSTON CHILDREN S HOSPITAL   (United States)

Author keywords

Asthma; Inhaled corticosteroid; Lung bioavailability; Preschool children; Valved holding chamber

Indexed keywords

FLUORINATED HYDROCARBON; FLUTICASONE PROPIONATE;

AGE; AREA UNDER THE CURVE; ARTICLE; ASTHMA; BLOOD SAMPLING; CHILD; CLINICAL ARTICLE; COMPARATIVE STUDY; COMPARTMENT MODEL; CONTROLLED STUDY; CORTICOSTEROID THERAPY; CROSSOVER PROCEDURE; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG ELIMINATION; EVENING DOSAGE; FACE MASK; FEMALE; HUMAN; MALE; METERED DOSE INHALER; MORNING DOSAGE; MULTIPLE DRUG DOSE; OPEN STUDY; PRESCHOOL CHILD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STEADY STATE; UNSPECIFIED SIDE EFFECT; VALVED HOLDING CHAMBER;

ADMINISTRATION, INHALATION; ADRENAL CORTEX HORMONES; ANDROSTADIENES; AREA UNDER CURVE; ASTHMA; BIOLOGICAL AVAILABILITY; BRONCHODILATOR AGENTS; CHILD, PRESCHOOL; CROSS-OVER STUDIES; DRUG ADMINISTRATION SCHEDULE; EQUIPMENT DESIGN; FEMALE; HOSPITALS, PEDIATRIC; HUMANS; INFANT; LUNG; MALE; NEBULIZERS AND VAPORIZERS;

EID: 84855372665     PISSN: 09031936     EISSN: 13993003     Source Type: Journal    
DOI: 10.1183/09031936.00185510     Document Type: Article

References (51)

1. Amirav I, Newhouse MT. Review of optimal characteristics of face-masks for valved-holding chambers (VHCs). Pediatr Pulmonol 2008; 43: 268-274. (Pubitemid 351374459)
2. Rubin BK, Fink JB. Optimizing aerosol delivery by pressurized metered-dose inhalers. Respir Care 2005; 50: 1191-1200.
3. Shah SA, Berlinski AB, Rubin BK. Force-dependent static dead space of face masks used with holding chambers. Respir Care 2006; 51: 140-144. (Pubitemid 46888412)
4. Amirav I, Newhouse MT. Aerosol therapy with valved holding chambers in young children: importance of the facemask seal. Paediatrics 2001; 108: 389-394.
5. National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. US Dept of Health and Human Services, Public Health Service, National Institutes of Health, National Heart, Lung, and Blood Institute, Publication No. 08-4051. Bethesda, US Dept of Health and Human Services, 2007.
6. Blake K, Madabushi R, Derendorf H, et al. Population pharmacodynamic model of bronchodilator response to inhaled albuterol in children and adults with asthma. Chest 2008; 134: 981-989.
7. Liang J, Asmus MJ, Hochhaus G, et al. Differences in inhaled fluticasone bioavailability between holding chambers in children with asthma. Pharmacotherapy 2002; 22: 947-953. (Pubitemid 34831289)
8. Khan Y, Tang Y, Hochhaus G, et al. Lung bioavailability of hydrofluoroalkane fluticasone in young children when delivered by an antistatic chamber/mask. J Pediatr 2006; 149: 793-797. (Pubitemid 44816340)
9. Drug Topics. 2010 Top 200 branded drugs by total prescriptions. http://drugtopics.modernmedicine.com/drugtopics/data/articlestandard// drugtopics/252011/727243/article.pdf Date last accessed: October 26, 2011. Date last updated: 2011.
10. Falcoz C, Oliver R, McDowall JE, et al. Bioavailability of orally administered micronised fluticasone propionate. Clin Pharmacokinet 2000; 39: Suppl. 1, 9-15.
11. Harding SM. The human pharmacology of fluticasone propionate. Respir Med 1990; 84: Suppl. A, 25-29.
12. Dempsey OJ, Coutie WJ, Wilson AM, et al. Evaluation of the buccal component of systemic absorption with inhaled fluticasone propionate. Thorax 1999; 54: 614-617. (Pubitemid 29296682)
13. Mollmann H, Wagner M, Meibohm B, et al. Pharmacokinetic and pharmacodynamic evaluation of fluticasone propionate after inhaled administration. Eur J Clin Pharmacol 1998; 53: 459-467. (Pubitemid 28154747)
14. Derendorf H, Nave R, Drollmann A, et al. Relevance of pharmacokinetics and pharmacodynamics of inhaled corticosteroids to asthma. Eur Respir J 2006; 28: 1042-1050. (Pubitemid 46335529)
15. Zak M, Madsen J, Berg E, et al. A mathematical model of aerosol holding chambers. J Aerosol Med 1999; 12: 187-196. (Pubitemid 29441629)
16. Berg E, Madsen J, Bisgaard H. In vitro performance of three combinations of spacers and pressurized metered dose inhalers for treatment in children. Eur Respir J 1998; 12: 472-476. (Pubitemid 28389548)
17. Voeurng V, Andrieu V, Bun H, et al. A new small volume holding chamber for asthmatic children: comparison with Babyhaler spacer. Pediatr Allergy Immunol 2006; 17: 629-634. (Pubitemid 44787822)
18. Anderson BJ, Allegaert K, Holford NH. Population clinical pharmacology of children: general principles. Eur J Pediatr 2006; 165: 741-746. (Pubitemid 44440510)
19. Callejas SL, Biddlecombe RA, Jones AE, et al. Determination of the glucocorticoid fluticasone propionate in plasma by automated solid-phase extraction and liquid chromatography-tandem mass spectrometry. J Chromatogr B Biomed Sci Appl 1998; 718: 243-250. (Pubitemid 28499998)
20. Beal SL, Scheiner LB. NONMEMUsers Guide-Part VII. Conditional Estimation Methods. San Francisco, University of California at San Francisco, 1992.
21. NONMEM Project Group. NONMEM Users Guide 1998. San Francisco, University of California at San Francisco, 1998.
22. Mehta R, Hu C, Beerahee M, et al. Different ways of handling data below assay sensitivity limit using NONMEM and BUGS: effects on fluticasone propionate pharmacokinetics in asthmatic children aged 6 months-4 years. J Clin Pharmacol 2003; 43: 1034.
23. Anderson BJ, Allegaert K, Holford NH. Population clinical pharmacology of children: modelling covariate effects. Eur J Pediatr 2006; 165: 819-829. (Pubitemid 44627767)
24. Qaqundah PY, Sugerman RW, Ceruti E, et al. Efficacy and safety of fluticasone propionate hydrofluoroalkane inhalation aerosol in pre-school-age children with asthma: a randomized, double-blind, placebo-controlled study. J Pediatr 2006; 149: 663-670.
25. Carlsen KC, Stick S, Kamin W, et al. The efficacy and safety of fluticasone propionate in very young children with persistent asthma symptoms. Respir Med 2005; 99: 1393-1402. (Pubitemid 41487497)
26. Whelan GJ, Blumer JL, Martin RJ, et al. Fluticasone propionate plasma concentration and systemic effect: effect of delivery device and duration of administration. J Allergy Clin Immunol 2005; 116: 525-530. (Pubitemid 41267123)
27. Kamin W, Ehlich H. In vitro comparison of output and particle size distribution of budesonide from metered-dose inhaler with three spacer devices during pediatric tidal breathing. Treat Respir Med 2006; 5: 503-508. (Pubitemid 44968307)
28. Pierart F, Wildhaber JH, Vrancken I, et al. Washing plastic spacers in household detergent reduces electrostatic charge and greatly improves delivery. Eur Respir J 1999; 13: 673-678. (Pubitemid 29180184)
29. Wildhaber JH, Waterer GW, Hall GL, et al. Reducing electrostatic charge on spacer devices and bronchodilator response. Br J Clin Pharmacol 2000; 50: 277-280.
30. Kenyon CJ, Thorsson L, Borgstrom L, et al. The effects of static charge in spacer devices on glucocorticosteroid aerosol deposition in asthmatic patients. Eur Respir J 1998; 11: 606-610. (Pubitemid 28194851)
31. Lipworth BJ, Lee DK, Anhoj J, et al. Effect of plastic spacer handling on salbutamol lung deposition in asthmatic children. Br J Clin Pharmacol 2002; 54: 544-547. (Pubitemid 35356883)
32. Amirav I, Mansour Y, Mandelberg A, et al. Redesigned face mask improves "real life" aerosol delivery for Nebuchamber. Pediatr Pulmonol 2004; 37: 172-177. (Pubitemid 38120988)
33. Hayden JT, Smith N, Woolf DA, et al. A randomised crossover trial of facemask efficacy. Arch Dis Child 2004; 89: 72-73. (Pubitemid 38122018)
34. Esposito-Festen JE, Ates B, van Vliet FJ, et al. Effect of a facemask leak on aerosol delivery from a pMDI-spacer system. J Aerosol Med 2004; 17: 1-6. (Pubitemid 38520667)
35. Bender B, Wamboldt FS, O'Connor SL, et al. Measurement of children's asthma medication adherence by self report, mother report, canister weight, and Doser CT. Ann Allergy Asthma Immunol 2000; 85: 416-421.
36. Krishnan JA, Riekert KA, McCoy JV, et al. Corticosteroid use after hospital discharge among high-risk adults with asthma. Am J Respir Crit Care Med 2004; 170: 1281-1285. (Pubitemid 39657191)
37. Kearns GL, Lu S, Maganti L, et al. Pharmacokinetics and safety of montelukast oral granules in children 1 to 3 months of age with bronchiolitis. J Clin Pharmacol 2008; 48: 502-511. (Pubitemid 351389113)
38. Daley-Yates PT, Richards DH. Relationship between systemic corticosteroid exposure and growth velocity: development and validation of a pharmacokinetic/pharmacodynamic model. Clin Ther 2004; 26: 1905-1919. (Pubitemid 40089503)
39. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention. NHLBI/WHO Workshop Report. NIH Publication No 02-3659. Bethesda, National Institutes of Health, 2009.
40. Agertoft L, Pedersen S. Effect of long-term treatment with inhaled budesonide on adult height in children with asthma. N Engl J Med 2000; 343: 1064-1069.
41. Bisgaard H, Allen D, Milanowski J, et al. Twelve-month safety and efficacy of inhaled fluticasone propionate in children aged 1 to 3 years with recurrent wheezing. Pediatrics 2004; 113: e87-e94.
42. Hoekstra MO, Grol MH, Bouman K, et al. Fluticasone propionate in children with moderate asthma. Am J Respir Crit Care Med 1996; 154: 1039-1044.
43. Kannisto S, Korppi M, Remes K, et al. Adrenal suppression, evaluated by a low dose adrenocorticotropin test, and growth in asthmatic children treated with inhaled steroids. J Clin Endocrinol Metab 2000; 85: 652-657. (Pubitemid 32279602)
44. Eid N, Morton R, Olds B, et al. Decreased morning serum cortisol levels in children with asthma treated with inhaled fluticasone propionate. Paediatrics 2002; 109: 217-221. (Pubitemid 34126860)
45. Santiago AH, Ratzan S. Acute adrenal crisis in an asthmatic child treated with inhaled fluticasone proprionate. Int J Pediatr Endocrinol 2010; 2010: 749239.
46. Mortimer KJ, Harrison TW, Tang Y, et al. Plasma concentrations of inhaled corticosteroids in relation to airflow obstruction in asthma. Br J Clin Pharmacol 2006; 62: 412-419. (Pubitemid 44401524)
47. Brutsche MH, Brutsche IC, Munawar M, et al. Comparison of pharmacokinetics and systemic effects of inhaled fluticasone propionate in patients with asthma and healthy volunteers: a randomised crossover study. Lancet 2000; 356: 556-561. (Pubitemid 30611861)
48. Szefler SJ, Martin RJ, King TS, et al. Significant variability in response to inhaled corticosteroids for persistent asthma. J Allergy Clin Immunol 2002; 109: 410-418. (Pubitemid 34234189)
49. Donnelly R, Williams KM, Baker AB, et al. Effects of budesonide and fluticasone on 24-hour plasma cortisol. A dose-response study. Am J Respir Crit Care Med 1997; 156: 1746-1751. (Pubitemid 28011777)
50. Szefler SJ, Boushey HA, Pearlman DS, et al. Time to onset of effect of fluticasone propionate in patients with asthma. J Allergy Clin Immunol 1999; 103: 780-788. (Pubitemid 29297579)
51. Kelly HW. Comparison of inhaled corticosteroids: an update. Ann Pharmacother 2009; 43: 519-527.