A critical review of the effects of inhaled corticosteroids on growth

Allergy and Asthma Proceedings

Volumn 35, Issue 5, 2013, Pages 391-407

  Bartholow, Ashton K ^a   Deshaies, Derek M ^b   Skoner, Julianne M ^c   Skoner, David P ^a,d  

^a ALLEGHENY GENERAL HOSPITAL   (United States)

^b JUNIATA COLLEGE   (United States)

^c SAINT FRANCIS UNIVERSITY   (United States)

^d TEMPLE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BECLOMETASONE DIPROPIONATE; BETA 2 ADRENERGIC RECEPTOR STIMULATING AGENT; BRONCHODILATING AGENT; CICLESONIDE; CORTICOSTEROID; CROMOGLYCATE DISODIUM; FLUNISOLIDE; FLUTICASONE PROPIONATE; MOMETASONE FUROATE; MONTELUKAST; PLACEBO; TRIAMCINOLONE ACETONIDE;

ASTHMA; CHILD GROWTH; CONFERENCE PAPER; CORTICOSTEROID THERAPY; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG RECEPTOR BINDING; DRUG SAFETY; DRY POWDER INHALER; EVENING DOSAGE; GROWTH DISORDER; GROWTH RATE; HUMAN; METERED DOSE INHALER; MORNING DOSAGE; SIDE EFFECT; SINGLE DRUG DOSE; ADULT; ANIMAL; BODY HEIGHT; CHILD; DRUG EFFECT; FOOD AND DRUG ADMINISTRATION; GROWTH; HYPOPHYSIS ADRENAL SYSTEM; INHALATIONAL DRUG ADMINISTRATION; METHODOLOGY; PRACTICE GUIDELINE; REVIEW; UNITED STATES; DRUG EFFECTS;

ADMINISTRATION, INHALATION; ADRENAL CORTEX HORMONES; ADULT; ANIMALS; ASTHMA; BODY HEIGHT; CHILD; GROWTH; HUMANS; PITUITARY-ADRENAL SYSTEM; PRACTICE GUIDELINES AS TOPIC; RESEARCH DESIGN; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84883686331     PISSN: 10885412     EISSN: 15396304     Source Type: Journal    
DOI: 10.2500/aap.2013.34.3689     Document Type: Conference Paper

References (107)

1. National Asthma Education and Prevention Program. Expert panel report: Guidelines for the diagnosis and management of asthma update on selected topics - 2002. J Allergy Clin Immunol 110(suppl 5):S141-S219, 2002.
2. Global Initiative for Asthma: Global strategy for asthma management and prevention. 2008 Available online at www.ginasthma.org.; accessed February 13, 2010.
3. Jeffery PK, Godfrey RW, Adelroth E, et al. Effects of treatment on airway inflammation and thickening of basement membrane reticular collagen in asthma. A quantitative light and electron microscopic study. Am Rev Respir Dis 145:890-899, 1992.
4. Allen DB. Effects of inhaled steroids on growth, bone metabolism, and adrenal function. Adv Pediatr 53:101-110, 2006.
5. Apter AJ, and Szefler SJ. Advances in adult and pediatric asthma. J Allergy Clin Immunol 117:512-518, 2006.
6. Allen-Ramey FC, Samet JM, Rand CS, and Joseph CL. Trends in use of inhaled corticosteroids for asthma management: 1994-1998. Ann Epidemiol 14:161-167, 2004.
7. Chaudry RQ, Weinstein ME, and Petrova A. Efficacy of inhaled compared to oral corticosteroids for acute asthma exacerbation in children. J Allergy Clin Immunol 125(suppl 1): AB69, 2010.
8. Pedersen S. Clinical safety of inhaled corticosteroids for asthma in children: An update of long-term trials. Drug Saf 29:599-612, 2006.
9. Global Initiative for Asthma. The global strategy for the diagnosis and management of asthma in children 5 years and younger. 2009 Available online at www.ginasthma.org/; accessed November 15, 2012.
10. Martin AJ, Landau LI, and Phelan PD, The effect on growth of childhood asthma. Acta Paediatr Scand 70:683-638, 1981.
11. Hauspie R, Susanne C, and Alexander F, Maturational delay and temporal growth retardation in asthmatic boys. J Allergy Clin Immunol 59:200-206, 1977.
12. Balfour-Lynn L. Growth and childhood asthma. Arch Dis Child 61:1049-1055, 1986.
13. Doull IJ. The effect of asthma and its treatment on growth. Arch Dis Child 89:60-63, 2004.
14. Lipworth BJ. Systemic adverse effects of inhaled corticosteroid therapy: A systematic review and meta-analysis. Arch Intern Med 159:941-955, 1999.
15. Allen DB, Bielory L, Derendorf H, et al. Inhaled corticosteroids: Past lessons and future issues. J Allergy Clin Immunol 112(suppl 3):S1-S40, 2003.
16. Daley-Yates PT, Price AC, Sisson JR, et al. Beclomethasone dipropionate: Absolute bioavailability, pharmacokinetics and metabolism following intravenous, oral, intranasal and inhaled administration in man. Br J Clin Pharmacol 51:400-409, 2001.
17. Pedersen S. Do inhaled corticosteroids inhibit growth in children? Am J Respir Crit Care Med 164:521-535, 2001.
18. Derendorf H, Nave R, Drollmann A, et al. Relevance of pharmacokinetics and pharmacodynamics of inhaled corticosteroids to asthma. Eur Respir J 28:1042-1050, 2006.
19. Cates CJ, Bestall J, and Adams N. Holding chambers versus nebulisers for inhaled steroids in chronic asthma. Cochrane Database Syst Rev 1:CD001491, 2006.
20. Selroos O. and Halme M. Effect of a volumatic spacer and mouth rinsing on systemic absorption of inhaled corticosteroids from a metered dose inhaler and dry powder inhaler. Thorax 46:891-894, 1991.
21. Toogood JH, White FA, Baskereville JC, et al. Comparison of the antiasthmatic, oropharyngeal, and systemic glucocorticoid effects of budesonide administered through a pressurized aerosol plus spacer or the Turbuhaler dry powder inhaler. J Allergy Clin Immunol 99:186-193, 1997.
22. Newman S, Salmon A, Nave R, and Drollmann A. High lung deposition of 99mTc-labeled ciclesonide administered via HFA-MDI to patients with asthma. Respir Med 100:375-384, 2006.
23. Gross G, Thompson PJ, Chervinsky P, and Vanden Burgt J. Hydrofluoroalkane-134a beclomethasone dipropionate, 400 microg, is as effective as chlorofluorocarbon beclomethasone dipropionate, 800 microg, for the treatment of moderate asthma. Chest 115:343-351, 1999.
24. Busse WW, Brazinsky S, Jacobson K, et al. Efficacy response of inhaled beclomethasone dipropionate in asthma is proportional to dose and is improved by formulation with a new propellant. J Allergy Clin Immunol 104:1215-1222, 1999.
25. Newman SP, and Newhouse MT. Effect of add-on devices for aerosol drug delivery: Deposition studies and clinical aspects. J Aerosol Med 9:55-70, 1996.
26. Vanden Burgt JA, Busse WW, Martin RJ, et al. Efficacy and safety overview of a new inhaled corticosteroid, QVAR (hydrofluoroalkane-beclomethasone extrafine inhalation aerosol), in asthma. J Allergy Clin Immunol 106:1209-1226, 2000.
27. Affrime MB, Cuss F, Padhi D, et al. Bioavailability and metabolism of mometasone furoate following administration by metered-dose and dry-powder inhalers in healthy human volunteers. J Clin Pharmacol 40:1227-1236, 2000.
28. Whelan GJ, Blumer JL, Martin RJ, and Szefler SJ. Fluticasone propionate plasma concentration and systemic effect: Effect of delivery device and duration of administration. J Allergy Clin Immunol 116:525-530, 2005.
29. 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 149:793-797, 2006.
30. Dempsey OJ, Humphreys M, Coutie WJ, and Lipworth BJ. Relative lung delivery of fluticasone propionate via large volume spacer or nebuliser in healthy volunteers. Eur J Clin Pharmacol 57:637-641, 2001.
31. Dempsey OJ, Wilson AM, Coutie WJ, and Lipworth BJ. Evaluation of the effect of a large volume spacer on the systemic bioactivity of fluticasone propionate metered-dose inhaler. Chest 116:935-940, 1999.
32. Dickens GR, Wermeling DP, Matheny CJ, et al. Pharmacokinetics of flunisolide administered via metered dose inhaler with and without a spacer device and following oral administration. Ann Allergy Asthma Immunol 84:528-532, 2000.
33. Liang J, Asmus MJ, Hochhaus G, et al. Differences in inhaled fluticasone bioavailability between holding chambers in children with asthma. Pharmacotherapy 22:947-953, 2002.
34. ElMallah MK, and Hendeles L. Delivery of medications by metered dose inhaler through a chamber/mask to young children with asthma. Pediatr Allergy Immunol Pulmonol 25:236-240, 2012.
35. Weiner P, Berar-Yanay N, Davidovich A, and Magadle R. Nocturnal cortisol secretion in asthmatic patients after inhalation of fluticasone propionate. Chest 116:931-934, 1999.
36. Agertoft L, and Pedersen S, Short-term lower-leg growth rate and urine cortisol excretion in children treated with ciclesonide. J Allergy Clin Immunol 115:940-945, 2005.
37. MacKenzie C. Effects of inhaled corticosteroids on growth. J Allergy Clin Immunol 101:S451-S455, 1998.
38. Allen DB. Limitations of short-term studies in predicting long-term adverse effects of inhaled corticosteroids. Allergy 54(suppl 49):29-34. 1999.
39. Gradman J, and Wolthers OD. A randomized trial of lower leg and height growth in children with asthma treated with inhaled budesonide from a new dry powder inhaler. Pediatr Allergy Immunol 21:e206-e212, 2010.
40. Wolthers OD. Short-term growth and adrenal function in children with asthma treated with inhaled beclomethasone dipropionate hydrofluoroalkane-134a. Pediatr Allergy Immunol 17: 613-619, 2006.
41. Heuck C, Wolthers OD, Hansen M, and Kollerup G. Shortterm growth and collagen turnover in asthmatic adolescents treated with the inhaled glucocorticoid budesonide. Steroids 62:659-664, 1997.
42. Heuck C, Wolthers OD, Kollerup G, et al. Adverse effects of inhaled budesonide (800 micrograms) on growth and collagen turnover in children with asthma: A double-blind comparison of once-daily versus twice-daily administration. J Pediatr 133: 608-612, 1998.
43. Agertoft L, and Pedersen S. Short-term knemometry and urine cortisol excretion in children treated with fluticasone propionate and budesonide: a dose response study. Eur Respir J 10:1507-1512, 1997.
44. Visser MJ, van Aalderen WM, Elliott BM, et al. Short-term growth in asthmatic children using fluticasone propionate. Chest 113:584-586, 1998.
45. Agertoft L, and Pedersen S. Lower-leg growth rates in children with asthma during treatment with ciclesonide and fluticasone propionate. Pediatr Allergy Immunol 21:e199-e205, 2010.
46. Efthimiou J, and Barnes PJ. Effect of inhaled corticosteroids on bones and growth. Eur Respir J 11:1167-1177, 1998.
47. Petrisko MA, Skoner JD, and Skoner DP. Safety and efficacy of inhaled corticosteroids (ICS) in children with asthma. J Asthma 45(suppl 1):1-9, 2008.
48. Food and Drug Administration. Orally inhaled and intranasal corticosteroids: Evaluation of the effects on growth in children. 2007 Available online at www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/ucm071968.pdf; accessed April 14, 2010.
49. Tanner JM, and Whitehouse RH. Clinical longitudinal standards for height, weight, height velocity, weight velocity, and stages of puberty. Arch Dis Child 51:170-179, 1976.
50. Verberne AA, Frost C, Roorda RJ, et al. One year treatment with salmeterol compared with beclomethasone in children with asthma. The Dutch Paediatric Asthma Study Group. Am J Respir Crit Care Med 156:688-695, 1997.
51. Pedersen S, Warner J, Wahn U, et al. Growth, systemic safety, and efficacy during 1 year of asthma treatment with different beclomethasone dipropionate formulations: An open-label, randomized comparison of extrafine and conventional aerosols in children. Pediatrics 109:e92, 2002.
52. Wolthers OD, and Walters EG. Short-term lower leg growth in 5-to 11-year-old asthmatic children using beclomethasone dipropionate inhalers with chlorofluorocarbon or hydrofluoroalkane propellants: A 9-week, open-label, randomized, crossover, noninferiority study. Clin Ther 33:1069-1076, 2011.
53. Leach CL, Davidson PJ, and Boudreau RJ. Improved airway targeting with the CFC-free HFA-beclomethasone metereddose inhaler compared with CFC-beclomethasone. Eur Respir J 12:1346-1353, 1998.
54. Martinez FD, Chinchilli VM, Morgan WJ, et al. Use of beclomethasone dipropionate as rescue treatment for children with mild persistent asthma (TREXA): A randomised, double-blind, placebo-controlled trial. Lancet 377:650-657, 2011.
55. Teper AM, Kofman CD, Maffey AF, et al. Effect of inhaled beclomethasone dipropionate on pulmonary function, bronchial reactivity and longitudinal growth in infants with bronchial asthma. Pediatric Res 39:369-369, 1996.
56. Agertoft L, and Pedersen S. Effects of long-term treatment with an inhaled corticosteroid on growth and pulmonary function in asthmatic children. Respir Med 88:373-381, 1994.
57. Pauwels RA, Pedersen S, Busse WW, et al. Early intervention with budesonide in mild persistent asthma: A randomised, double-blind trial. Lancet 361:1071-1076, 2003.
58. Szefler S, Weiss S, and Tonascia J. Long-term effects of budesonide or nedocromil in children with asthma. The Childhood Asthma Management Program Research Group. N Engl J Med 343:1054-1063, 2000.
59. Turpeinen M, et al. Daily versus as-needed inhaled corticosteroid for mild persistent asthma (The Helsinki early intervention childhood asthma study). Arch Dis Child 93:654-659, 2008.
60. Skoner DP, Szefler SJ, Welch M, et al. Longitudinal growth in infants and young children treated with budesonide inhalation suspension for persistent asthma. J Allergy Clin Immunol 105:259-268, 2000.
61. Zeiger RS, Mauger D, Bacharier LB, et al. Daily or intermittent budesonide in preschool children with recurrent wheezing. N Engl J Med 365:1990-2001, 2011.
62. 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 113:e87-e94, 2004.
63. Roux C, Kolta S, Desfougeres JL, et al. Long-term safety of fluticasone propionate and nedocromil sodium on bone in children with asthma. Pediatrics 111:e706-e713, 2003.
64. Teper AM, Colom AJ, Kofman CD, et al. Effects of inhaled fluticasone propionate in children less than 2 years old with recurrent wheezing. Pediatr Pulmonol 37:111-115, 2004.
65. Allen DB, Bronsky EA, LaForce CF, et al. Growth in asthmatic children treated with fluticasone propionate. Fluticasone Propionate Asthma Study Group. J Pediatr 132:472-477, 1998.
66. Guilbert TW, Morgan WJ, Zeiger RS, et al. Long-term inhaled corticosteroids in preschool children at high risk for asthma. N Engl J Med 354:1985-1997, 2006.
67. Ducharme FM, Lemire C, Noya FJ, et al. Preemptive use of high-dose fluticasone for virus-induced wheezing in young children. N Engl J Med 360:339-353, 2009.
68. Skoner DP, Murphy K, Lemanske R, et al. Once-daily dosing of 100 μg mometasone furoate has no effect on growth velocity in children with asthma. Ann Allergy Asthma Immunol 102:A53, 2009.
69. Skoner DP, Dunn M, and Lee T. Effects of inhaled mometasone furoate on growth velocity and adrenal function: A placebocontrolled trial in children 4-9 years old with mild persistent asthma. J Asthma 48:848-859, 2011.
70. Skoner DP, Welch M, Tinkelman D, et al. Inhaled corticosteroid-induced growth retardation in asthmatic children in a "real-world" setting. J Allergy Clin Immunol 103:S61, 1999.
71. Becker AB, Kuznetsova O, Vermeulen J, et al. Linear growth in prepubertal asthmatic children treated with montelukast, beclomethasone, or placebo: A 56-week randomized doubleblind study. Ann Allergy Asthma Immunol 96:800-807, 2006.
72. Skoner DP, Maspero J, and Banerji D. Assessment of the longterm safety of inhaled ciclesonide on growth in children with asthma. Pediatrics 121:e1-e14, 2008.
73. Alvesco prescribing information. 2008. Sunovion Pharmaceuticals, Inc.: Marlborough, Massachusetts. Available online at www.alvesco.us/AlvescoPI.pdf; accessed June 23, 2010.
74. Malozowski S. Assessment of the long-term safety of inhaled ciclesonide on growth in children with asthma. Pediatrics 122: 213, 2008.
75. Kassai B, Cucherat M, and Bellon G. Ciclesonide noninferiority to placebo on growth velocity. Pediatrics 122:676-677, 2008.
76. Pedersen S, Potter P, Dachev S, et al. Efficacy and safety of three ciclesonide doses vs placebo in children with asthma: The RAINBOW study. Respir Med 104:1618-1628, 2010.
77. Bensch GW, Greos LS, Gawchik S, et al. Linear growth and bone maturation are unaffected by 1 year of therapy with inhaled flunisolide hydrofluoroalkane in prepubescent children with mild persistent asthma: A randomized, doubleblind, placebo-controlled trial. Ann Allergy Asthma Immunol 107:323-329, 2011.
78. de Benedictis FM, Teper A, Green RJ, et al. Effects of 2 inhaled corticosteroids on growth: Results of a randomized controlled trial. Arch Pediatr Adolesc Med 155:1248-1254, 2001.
79. Rao R, Gregson RK, Jones AC, et al. Systemic effects of inhaled corticosteroids on growth and bone turnover in childhood asthma: A comparison of fluticasone with beclomethasone. Eur Respir J 13:87-94, 1999.
80. Fitzgerald D, Van Asperen P, Mellis C, et al. Fluticasone propionate 750 micrograms/day versus beclomethasone dipropionate 1500 micrograms/day: Comparison of efficacy and adrenal function in paediatric asthma. Thorax 53:656-661, 1998.
81. Ferguson AC, Van Bever HP, Teper AM, et al. A comparison of the relative growth velocities with budesonide and fluticasone propionate in children with asthma. Respir Med 101:118-129, 2007.
82. Ferguson AC, Spier S, Manjra A, et al. Efficacy and safety of high-dose inhaled steroids in children with asthma: A comparison of fluticasone propionate with budesonide. J Pediatr 134:422-427, 1999.
83. Acun C, Tomac N, Ermis B, and Onk G. Effects of inhaled corticosteroids on growth in asthmatic children: A comparison of fluticasone propionate with budesonide. Allergy Asthma Proc 26:204-206, 2005.
84. Altintas DU, Karakoc GB, Can S, et al. The effects of long term use of inhaled corticosteroids on linear growth, adrenal function and bone mineral density in children. Allergol Immunopathol (Madr) 33:204-209, 2005.
85. von Berg A, Engelstatter R, Minic P, et al. Comparison of the efficacy and safety of ciclesonide 160 microg once daily vs. budesonide 400 microg once daily in children with asthma. Pediatr Allergy Immunol 18:391-400, 2007.
86. Garcia Garcia ML, Wahn U, Gilles L, et al. Montelukast, compared with fluticasone, for control of asthma among 6-to 14-year-old patients with mild asthma: The MOSAIC study. Pediatrics 116:360-369, 2005.
87. Sorkness CA, Lemanske RF Jr, Mauger DT, et al. Long-term comparison of 3 controller regimens for mild-moderate persistent childhood asthma: The Pediatric Asthma Controller Trial. J Allergy Clin Immunol 119:64-72, 2007.
88. Vaessen-Verberne AA, van den Berg NJ, van Nierop JC, et al. Combination therapy salmeterol/fluticasone versus doubling dose of fluticasone in children with asthma. Am J Respir Crit Care Med 182:1221-1227, 2010.
89. Heuck C, Heickendorff L, and Wolthers OD. A randomised controlled trial of short term growth and collagen turnover in asthmatics treated with inhaled formoterol and budesonide. Arch Dis Child 83:334-339, 2000.
90. Verberne AA, Frost C, Duiverman EJ, et al. Addition of salmeterol versus doubling the dose of beclomethasone in children with asthma. The Dutch Asthma Study Group. Am J Respir Crit Care Med 158:213-219, 1998.
91. Allen DB. Safety of inhaled corticosteroids in children. Pediatr Pulmonol 33:208-220, 2002.
92. Doull IJ, Freezer NJ, and Holgate ST. Growth of prepubertal children with mild asthma treated with inhaled beclomethasone dipropionate. Am J Respir Crit Care Med 151:1715-1719, 1995.
93. Doull IJ, Campbell MJ, and Holgate ST. Duration of growth suppressive effects of regular inhaled corticosteroids. Arch Dis Child 78:172-173, 1998.
94. Agertoft L, and Pedersen S. Effect of long-term treatment with inhaled budesonide on adult height in children with asthma. N Engl J Med 343:1064-1069, 2000.
95. Strunk RC, Sternberg AL, Szefler SJ, et al. Long-term budesonide or nedocromil treatment, once discontinued, does not alter the course of mild to moderate asthma in children and adolescents. J Pediatr 154:682-687, 2009.
96. Kelly HW, Sternberg AL, Lescher R, et al. Effect of inhaled glucocorticoids in childhood on adult height. N Engl J Med 367:904-912, 2012.
97. Padden J, Skoner DP, and Hochhaus G. Pharmacokinetics and pharmacodynamics of inhaled glucocorticoids. J Asthma 45: 13-24, 2008.
98. Dahlstrom K, Thorsson L, Larsson P, and Nikander K. Systemic availability and lung deposition of budesonide via three different nebulizers in adults. Ann Allergy Asthma Immunol 90:226-232, 2003.
99. Agertoft L, Andersen A, Weibull E, and Pedersen S. Systemic availability and pharmacokinetics of nebulised budesonide in preschool children. Arch Dis Child 80:241-247, 1999.
100. Valotis A, Neukam K, Elert O, and Hogger P. Human receptor kinetics, tissue binding affinity, and stability of mometasone furoate. J Pharm Sci 93:1337-1350, 2004.
101. Rohatagi S, Luo Y, Shen L, et al. Protein binding and its potential for eliciting minimal systemic side effects with a novel inhaled corticosteroid, ciclesonide. Am J Ther 12:201-209, 2005.
102. Nave R, Bethke TD, van Marle SP, and Zech K. Pharmacokinetics of [14C]ciclesonide after oral and intravenous administration to healthy subjects. Clin Pharmacokinet 43:479-486, 2004.
103. Pickering H, Pitcairn GR, Hirst PH, et al. Regional lung deposition of a technetium 99m-labeled formulation of mometasone furoate administered by hydrofluoroalkane 227 metered-dose inhaler. Clin Ther 22:1483-1493, 2000.
104. Vaghi A, Berg E, Liljedahl S, and Svensson JO. In vitro comparison of nebulised budesonide (Pulmicort Respules) and beclomethasone dipropionate (Clenil per Aerosol). Pulm Pharmacol Ther 18:151-153, 2005.
105. Thorsson L, Edsbäcker S, and Conradson TB. Lung deposition of budesonide from Turbuhaler is twice that from a pressurized metered-dose inhaler P-MDI. Eur Respir J 7:1839-1844, 1994.
106. Hirst PH, Bacon RE, Pitcairn GR, et al. A comparison of the lung deposition of budesonide from Easyhaler, Turbuhaler and pMDI plus spacer in asthmatic patients. Respir Med 95: 720-727, 2001.
107. Mollmann H, Wagner M, Meibohm B, et al. Pharmacokinetic and pharmacodynamic evaluation of fluticasone propionate after inhaled administration. Eur J Clin Pharmacol 53:459-467, 1998.