A comparison of the efficacy and safety of inhaled corticosteroids in asthma

Allergy: European Journal of Allergy and Clinical Immunology

Volumn 52, Issue SUPPL. 39, 1997, Pages 1-34

  Pedersen, S ^a   O'Byrne, P ^b  

^a UNIVERSITY OF SOUTHERN DENMARK   (Denmark)

^b MCMASTER UNIVERSITY   (Canada)

Author keywords

Dose response; Efficacy; Inhaled corticosteroids; Safety; Study design

Indexed keywords

BECLOMETASONE DIPROPIONATE; BUDESONIDE; CORTICOSTEROID; FLUNISOLIDE; FLUTICASONE PROPIONATE; TRIAMCINOLONE ACETONIDE;

ADRENAL SUPPRESSION; ASTHMA; CORTICOSTEROID THERAPY; DRUG ABSORPTION; DRUG EFFECT; DRUG EFFICACY; DRUG RECEPTOR BINDING; DRUG SAFETY; FRACTURE; GROWTH DISORDER; HUMAN; OSTEOPOROSIS; PRIORITY JOURNAL; REVIEW;

ADMINISTRATION, INHALATION; ADRENAL CORTEX HORMONES; ASTHMA; HUMANS;

EID: 0030764645     PISSN: 01054538     EISSN: 13989995     Source Type: Journal    
DOI: 10.1111/j.1398-9995.1997.tb05047.x     Document Type: Article

References (173)

1. National Institutes of Health, National Heart, Lung and Blood Institute. Global initiative for asthma. Global strategy for asthma management and prevention. NHLBI/ WHO Workshop Report March 1993. Bethesda: National Heart, Lung and Blood Institute, National Institutes of Health, US Department of Health and Human Services, 1995.
2. Haahtela T, Järvinen M, Kava T, Kiviranta K, Koskinen S, Lehtonen K, Nikander K, Persson T, Selroos O, Sovijärvi A, Stenius-Aaraiala B, Svahn T, Tammivaara R, Laitinen LA. Effect of reducing or discontinuing inhaled budesonide in patients with mild asthma. N Engl J Med 1994;331:700-3.
3. Agertoft L, Pedersen S. Effects of long-term treatment with an inhaled corticosteroid on growth and pulmonary function in asthmatic children. Respir Med 1994;88:373-81.
4. Barnes PJ, Pedersen S. Efficacy and safety of inhaled corticosteroids in asthma. Am Rev Respir Dis 1993;148 (No 4 pt 2):S1-S26.
5. Barnes PJ, Adcock I. Anti-inflammatory actions of steroids: molecular mechanisms. Trends Pharmacol Sci 1993;14:436-41.
6. Scheinman RI, Cogswell PC, Lofquist AK, Baldwin AS. Role of transcriptional activation of I kappa B alpha in mediation of immunosuppression by glucocorticoids. Science 1995;270:283-6.
7. Collins S, Caron MG, Lefkowitz RJ. Beta-adrenergic receptors in hamster smooth muscle cells are transcriptionally regulated by glucocorticoids. J Biol Chem 1988;263:9067-70.
8. 2-adrenoceptor gene expression in human lung. Am Rev Respir Dis 1992;145:A834.
9. Brattsand R, Thalén A, Roempke K, Källström L, Gruvstad E. Development of new glucocorticosteroids with a very high ratio between topical and systemic activities. Eur J Respir Dis 1982;63 (Suppl 122):62-73.
10. Phillipps GH. Structure-activity relationships of topically active steroids: the selection of fluticasone propionate. Respir Med 1990;84 (Suppl A):19-23.
11. Brattsand R, Selroos O. Current drugs for respiratory diseases: glucocorticosteroids. In: Page CP, Metzger WJ (eds). Drugs and the lung. New York: Raven Press Ltd, 1994;101-220.
12. Dahlberg E, Thalén A, Brattsand R, Gustafsson JÅ, Johansson U, Roempke K, Saartok T. Correlation between chemical structure, receptor binding, and biological activity of some novel, highly active, 16alpha, 17alpha-acetal-substituted glucocorticoids. Mol Pharmacol 1984;25: 70-8.
13. Brattsand R, Axelsson BI. New inhaled glucocorticosteroids. In: Barnes PJ (ed). New drugs for asthma. Volume 2, Chapter 13. London: 1992;193-208.
14. Brattsand R, Ingelf J. Pharmacodynamic and pharmacokinetic basis for inhaled glucocorticosteroid (GCS) therapy in allergic rhinitis. In: Melillo G, O'Byrne PM, Marone G (eds). Respiratory allergy: Advances in clinical immunology and pulmonary medicine. Amsterdam: Elsevier Science Publication B.V, 1993:129-36.
15. Brattsand R. Development of glucocorticoids with lung selectivity. In: Hargreave FE, Hogg JC, Malo J-L, Toogood JH (eds). Glucocorticoids and mechanisms of asthma. Amsterdam: Excerpta Medica, 1989:17-38.
16. Andersson N, Klint S, Randwall G, Wirén JE. Equipotency of BUD and fluticasone propionate in the vasoconstriction assay. Am J Respir Crit Care Med 1994;149 (Suppl) (No 4 pt 2):A467.
17. Würthwein G, Rohdewald P. Activation of beclomethasone dipropionate by hydrolysis to beclomethasone-17-mono-propionate. Biopharm Drug Dispos 1990;11:381-94.
18. Rohdewald P, von Eiff M, Würthwein G. Activation of beclomethasone dipropionate in bronchial secretion and receptor affinities and solubility of inhalative applied glucocorticoids. Atemwegs-Lungenkrankh 1990;16:79-84.
19. Andersson P, Ryrfeldt Å. Biotransformation of the topical glucocorticoids budesonide and beclomethasone 17alpha,21- dipropionate in human liver and lung homoge-nate. J Pharm Pharmacol 1984;36:763-5.
20. Högger P, Rawert I, Rohdewald P. Dissolution, tissue binding and kinetics of receptor binding of inhaled glucocorticoids. Eur Respir J 1993;6 (Suppl 17):584s.
21. Axelsson B, Brattsand R, Andersson PH, Ryrfeldt Å, Thalén A. Relation between the glucocorticosteroid (GCS) effects of beclomethasone- 17alpha,21-dipropionate (BDP), beclomethasone-17alpha-propionate (BMP) and beclomethasone (B) as studied in human, mouse and rat tissue. Respiration 1984;46 (Suppl 1):4-5.
22. Ryrfeldt Å Andersson P, Edsbäcker S, Tennesson M, Davies D, Pauwels R. Pharmacokinetics and metabolism of budesonide, a selective glucocorticoid. Eur J Respir Dis 1982;63 (Suppl 122):86-95.
23. Edsbäcker S, Andersson P, Lindberg C, Ryrfeldt Å Thalén A. Metabolic acetai splitting of budesonide. A novel inactivation pathway for topical glucocorticoids. Drug Metab Dispos 1987;15:412-7.
24. Kaiser HH, Edsbäcker S. The Pulmicort Turbuhaler Study Group: Dose-proportional pharmacokinetics (PK) of inhaled budesonide (Pulmicort Turbuhaler) in patients with mild asthma. Am J Respir Crit Care Med 1994;149 (Suppl) (No 4 pt 2):A467.
25. Harding SM. The human pharmacology of fluticasone propionate. Respir Med 1990;84 (Suppl A):25-9.
26. Falcoz C, Mackie AE, McDowall J, McRae J, Yogendran L, Ventresca GP, Bye A. Oral bioavailability of fluticasone propionate in healthy subjects. Br J Clin Pharmacol 1996; 41:459-60P.
27. Mackie AE, Ventresca GP, Moss JA, Bye A. Pharmacokinetics of intravenous fluticasone propionate in healthy subjects. Br J Clin Pharmacol 1995;40:198P.
28. Thorsson L, Källén A, Wirén J-E, Paulson J. Pharmacokinetics of inhaled fluticasone propionate. Am J Respir Crit Care Med 1996;153 (Suppl) (No 4 pt 2):A801.
29. Lönnebo A, Grahnén A, Ling-Andersson A, Brundin RM, Eckernäs SÅ. A comparison of the effects on the HPA-axis of single and repeated doses of inhaled fluticasone propionate and BUD. Am J Respir Crit Care Med 1995;151(No 4 pt 2):A375.
30. McKenzie AW, Stoughton RB. Method for comparing percutaneous absorption of steroids. Arch Dermatol 1962; 86:608-10.
31. Place VA, Velazquez JG, Burdick KH. Precise evaluation of topically applied corticosteroid potency. Modification of the Stoughton-McKenzie assay. Arch Dermatol 1970;101: 531-7.
32. Randwall G Klint S, Söderblom M, Larsson P, Andersson N, Lindgren S. Topical activity of glucocorticosteroids in the vasoconstriction assay: method comparison. Eur Respir J 1994;7 (Suppl 18):381s.
33. Gruvstad E, Bengtsson B. A comparison of a new steroid, BUD, with other topical corticosteroids in the vasoconstriction assay. Drugs Exp Clin Res 1980;6:385-90.
34. Johansson SÅ, Andersson KE, Brattsand R, Gruvstad E, Hedner P. Topical and systemic glucocorticosteroid potencies of budesonide and beclomethasone dipropionate in man. Eur J Clin Pharmacol 1982;22:523-9.
35. English AE Neate MS, Quint DJ, Sareen M. Biological activities of some corticosteroids used in asthma. Am J Respir Crit Care Med 1994;149 (Suppl) (No 4 Pt 2): A212.
36. Johnson M. Anti-inflammatory properties of fluticasone propionate. Int Arch Allergy Immunol 1995;107:439-40.
37. Hughes SC, Vardey CJ, Whelan CJ. Inhaled fluticasone propionate is a potent inhibitor of PAF-induced eosinophil accumulation in guinea-pig lung. Eur Respir J 1993;6 (Suppl 17):585s.
38. Miller-Larsson A, Mattson H, Ohlsson D, Hjertberg E, Tunek A, Dahlbäck M, Brattsand R. Prolonged release from the airway tissue of glucocorticoids budesonide and fluticasone propionate as compared to beclomethasone dipropionate and hydrocortisone. Am J Respir Crit Care Med 1994;149 (Suppl) (No 4 pt 2):A466.
39. Toogood JH, Frankish CW, Jennings BH, Baskerville JC, Borga O, Lefcoe NM, Johansson SA. A study of the mechanism of the antiasthmatic action of inhaled BUD. J Allergy Clin Immunol 1990;85:872-80.
40. Falcoz C, Kirby SM, Smith J, Olsson P, Ventresca GP. Pharmacokinetics and systemic exposure of inhaled beclomethasone dipropionate. Eur Respir J 1996;9 (Suppl 23) :162s.
41. Brogden RN, McTavish D. Budesonide: an updated review of its pharmacological properties, and therapeutic efficacy in asthma and rhinitis. Drugs 1992;44:375-407.
42. Dahlström K, Edsbäcker S, Källén A. Rectal pharmacokinetics of budesonide. Eur J Clin Pharmacol 1996;49: 293-8.
43. Trescoli-Serrano C, Ward MJ, Garcia-Zarco M, Rajput R. Gastrointestinal absorption of inhaled budesonide and beclomethasone: has it any significant systemic effect? Am J Respir Crit Care Med 1995;151(No 4 pt 2):A375.
44. Pedersen S. Inhalers and nebulisers: which to choose and why. Respir Med 1996;90:69-77.
45. Jackson C, Lipworth B. Optimizing inhaled drug delivery in patients with asthma. Br J Gen Pract 1995;45:683-7.
46. Borgström L. Methodological studies on lung deposition. Evaluation of inhaler devices and absorption mechanisms. In: Act Univ Upps, Comprehensive summaries from the Uppsala Faculty of Pharmacy, University of Uppsala 1993;105.
47. O'Callaghan C, Cant M, Robertson C. Delivery of beclomethasone dipropionate from a spacer device: what dose is available for inhalation? Thorax 1994;49:961-4.
48. Barry PW, O'Callaghan C. The effect of delay, multiple actuations and spacer static charge on the in-vitro delivery of budesonide from the Nebuhaler. Br J Clin Pharmacol 1995; 40:76-8.
49. Olsson B. Aerosol particle generation from dry-powder inhalers - can they equal pressurized metered dose inhalers? J Aerosol Med 1995;8 (Suppl 3):S13-9.
50. Pedersen S, Steffensen G, Ohlsson SV. The influence of orally deposited budesonide on the systemic availability of budesonide after inhalation from a Turbuhaler. Br J Clin Pharmacol 1993;36:211-4.
51. Thorsson L, Edsbäcker S, Conradson TB. Lung deposition of budesonide from Turbuhaler is twice that from a pressurized metered dose inhaler P-MDI. Eur Respir J 1994;7:1839-44.
52. Selroos O, 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 1991;46:891-4.
53. Agertoft L, Pedersen S. Importance of the inhalation device on the effect of budesonide. Arch Dis Child 1993;69: 130-3.
54. Toogood JH, Lefcoe NM, Haines DS, Jennings B, Errington N, Baksh L, Chuang L. A graded dose assessment of the efficacy of beclomethasone dipropionate aerosol for severe chronic asthma. J Allergy Clin Immunol 1977;59:298-308.
55. EUul-Micallef R, Johansson SÅ. Acute dose-response studies in bronchial asthma with a new corticosteroid, BUD. Br J Clin Pharmacol 1983;15:419-22.
56. Toogood JH, Lefcoe NM, Haines DS, Chuang L, Jennings B, Errington N, Baksh L, Cauchi M. Minimum dose requirements of steroid-dependent asthmatic patients for aerosol beclomethasone and oral prednisone. J Allergy Clin Immunol 1978;61:355-64.
57. Toogood JH, Baskerville JC, Jennings B, Lefcoe NM, Johansson SÅ. Influence of dosing frequency and schedule on the response of chronic asthmatics to the aerosol steroid, budesonide. J Allergy Clin Immunol 1982;70: 288-98.
58. Toogood JH, Baskerville J, Jennings B, Lefcoe NM, Johansson SÅ. Use of spacers to facilitate inhaled corticosteroid treatment of asthma. Am Rev Respir Dis 1984; 129:723-9.
59. Toogood JH. Comparisons between inhaled and oral corticosteroids in patients with chronic asthma. In: Ellul-Micallef R, Lam WK, Toogood JH (eds). Advances in the Use of Inhaled Corticosteroids. Hong Kong: Excerpta Medica, 1987;140-9.
60. Busse W. Dose-related efficacy of Pulmicort® (BUD) Turbuhaler® in moderate to severe asthma. J Allergy Clin Immunol 1994;93 (Suppl) (No 1 pt 2):186.
61. Dahl R, Lundbäck B, Malo JM, Mazza JA, Nieminen MM, Saarelainen P, Barnacle H. A dose-ranging study of fluticasone propionate in adult patients with moderate asthma. Chest 1993;104:1352-8.
62. Gibson PG, Wong BJ, Hepperle MJ, Kline PA, Girgis-Gabardo A, Guyatt G, Dolovich J, Denburg JA, Ramsdale EH, Hargreave FE. A research method to induce and examine a mild exacerbation of asthma by withdrawal of inhaled corticosteroid. Clin Exp Allergy 1992;22:525-32.
63. Kraan J, Koeter GH, van der Mark TW, Boorsma M, Kukler J, Sluiter HJ, de Vries K. Dosage and time effects of inhaled budesonide on bronchial hyperreactivity. Am Rev Respir Dis 1988;137:44-8.
64. Pedersen S, Ramsgaard-Hansen O. Budesonide treatment of moderate and severe asthma in children: a dose-response study. J Allergy Clin Immunol 1995;95:29-33.
65. Van Essen-Zandvliet EE, Hughes MD, Waalkens HJ, Duiverman EJ, Pocock SJ, Kerrebijn KF, Dutch CNSLD study group. Effects of 22 months' treatment with inhaled corticosteroids and/or beta-2-agonists on lung function, airway responsiveness, and symptoms in children with asthma. Am Rev Respir Dis 1992;146:547-54.
66. Haahtela T, Järvinen M, Kava T, Kiviranta K, Koskinen S, Lehtonen K, Nikander K, Persson T, Reinikainen K, Selroos O, Sovijärvi A, Stenius-Aarniala B, Svahn T, Tammivaara R, Laitinen LA. Comparison of a beta2-agonist, terbutaline, with an inhaled corticosteroid, BUD, in newly detected asthma. N Engl J Med 1991;325:388-92.
67. Selroos O, Backman R, Forsén KO, Lofroos AB, Niemistö M, Nyberg P, Nyholm JE, Pietinalho A, Riska H. The effect of inhaled corticosteroids in asthma is related to the duration of pretreatment symptoms. Am J Respir Crit Care Med 1994;149 (Suppl) (No 4pt 2):A211.
68. Overbeek SE, Kerstjens HA, Bogaard JM, Mulder PG, Postma DS. Is delayed introduction of inhaled corticosteroids harmful in patients with obstructive airways disease (asthma and COPD)? Chest 1996;1:35-41.
69. Laitinen LA, Laitinen A, Haahtela T. A comparative study of the effects of an inhaled corticosteroid, budesonide, and a beta2-agonist, terbutaline, on airway inflammation in newly diagnosed asthma: a randomized double-blind, parallel-group controlled trial. J Allergy Clin Immunol 1992;90: 32-42.
70. Geddes DM. Inhaled corticosteroids: benefits and risks. Thorax 1992;47:404-7.
71. Gaddie J, Reid IW, Skinner C, Pétrie GR, Sinclair DJ, Palmer KN. Aerosol beclomethasone dipropionate: a dose-response study in chronic bronchial asthma. Lancet 1973 August 11;2(824):280-1.
72. Brompton Hospital and Medical Research Council. Double blind trial comparing two dosage schedules of beclomethasone dipropionate aerosol with a placebo in chronic bronchial asthma. J Dis Chest 1979;73:121-3.
73. Hummel S, Lehtonen L, Adolph J, Gronke K, Kandt D, Lorsbach H, Mohorn M, Possner S, Rabe U, Seelig U, Slapke J, Wenz W, Winterstein KH, Glende M, Meiske W, Hirsjarvi-Lahti T. Comparison of oral-steroid-sparing by high-dose and low-dose inhaled steroid in maintenance treatment of severe asthma. Lancet 1992;340:1483-7.
74. Laursen LC, Taudorf E, Weeke B. High-dose inhaled BUD in treatment of severe steroid-dependent asthma. Eur J Respir Dis 1986;68:19-28.
75. Tukiainen P, Lahdensuo A. Effect of inhaled budesonide on severe steroid-dependent asthma. Eur J Respir Dis 1987;70:239-44.
76. Johansson SA, Dahl R. A double-blind dose-response study of budesonide by inhalation in patients with bronchial asthma. Allergy 1988;43:173-8.
77. Shapiro GG. Double-blind, randomized trial of three doses of inhaled budesonide vs placebo in children with steroid-dependent asthma. Abstract presented at the 1994 annual meeting of the American Academy of Paediatrics, Dallas, Texas, USA, Oct 22-3,1994 - Program booklet, section on Allergy and Immunology: 35-6.
78. Chervinsky P, Van As A, Bronsky EA, Dockhorn R, Noonan M, LaForce C, Pleskow W. Fluticasone propionate aerosol for the treatment of adults with mild to moderate asthma. J Allergy Clin Immunol 1994;94:676-83.
79. Noonan MJ, Chervinsky P, Busse WW, Weisberg SC, Pinnas J, de Boisblanc P, Boltansky H, Pearlman D, Repsher L, Kellerman DJ. Fluticasone propionate reduces oral prednisolone use while it improves asthma control and quality of life. Am J Respir Crit Care Med 1995;152: 1467-73.
80. Katz Y, Lebas FX, Medley HV. Double-blind placebo controlled parallel-group study to compare the efficacy and safety of fluticasone propionate at two doses delivered via a Diskhaler in children with asthma. Am J Respir Crit Care Med 1996;153 (Suppl) (No 4pt 2):A75.
81. Boe J, Rosenhall L, Alton M, Carlsson LG, Carlsson U, Hermansson BA, Hetta L, Kiviloog J, Karlson BW, Lundbäck B, Martinsson JE, Nemcek K, Nemcek V. Comparison of dose-response effects of inhaled beclomethasone dipropionate and BUD in the management of asthma. Allergy 1989;44:349-55.
82. Agertoft L, Pedersen S. A randomized double-blind dose reduction study to compare the minimal effective dose of budesonide Turbuhaler® and fluticasone propionate Diskhaler®. Am J Respir Crit Care Med 1996;153 (Suppl) (No 4 pt 2): A408.
83. Basran G, Scott R, Campbell M, Knox A, Smith R, Vernon J, Wade A. A study to compare the efficacy of budesonide (Pulmicort Turbuhaler) and fluticasone propionate (Flixotide Diskhaler) in the treatment of asthma. Thorax 1995;50:469P.
84. Brambilla C, Lacronique J, Allaert FA, Godard P, Duroux P, French Budesonide Trial Group. A 3-month comparative dose-reduction study with inhaled beclomethasone dipropionate and budesonide in the management of moderate to severe adult asthma. Drug Invest 1994;8:49-56.
85. Selroos O, Backman R, Forsén KO, Löfroos AB, Niemistö M, Pietinalho A, Riska H. Clinical efficacy of budesonide Turbuhaler compared with that of beclomethasone dipropionate pMDI with volumatic spacer: a 2-year randomized study in 102 patients. Allergy 1994;49:833-6.
86. Rafferty P, Tucker LG, Frame MH, Fergusson RJ, Biggs BA, Crompton GK. Comparison of budesonide and beclomethasone dipropionate in patients with severe chronic asthma. Assessment of relative prednisolone-sparing effects. Br J Dis Chest 1985;79:244-50.
87. Ebden P, Jenkins A, Houston G, Davies BH. Comparison of two high-dose corticosteroid aerosol treatments, beclomethasone dipropionate (1500 μg/day) and budesonide (1600μg/day), for chronic asthma. Thorax 1986;41:869-74.
88. Baran D. A comparison of inhaled budesonide and beclomethasone dipropionate in childhood asthma. Br J Dis Chest 1987;81:170-5.
89. Tjwa MK. Budesonide inhaled via Turbuhaler: a more effective treatment for asthma than beclomethasone dipropionate via Rotahaler. Ann Allergy Asthma Immunol 1995;75:107-11.
90. Piquet J, Zuck P, Dennewald G, Dugue P, Grivaux M, Brun P, et al. Equally efficacious asthma management with budesonide 800 μg administered by Turbuhaler® or with beclomethasone dipropionate >1500μg given through a pressurised metered-dose inhaler with spacer. Advances in Therapy 1996;13:39-50.
91. Boe J, Bakke P, Rödölen T, Skovlund E, Gulsvik A. High-dose inhaled steroids in asthmatics: moderate efficacy gain and suppression of the hypothalamic-pituitary-adrenal (HPA) axis. Eur Respir J 1994;7:2179-84.
92. Fabbri L, Burge PS, Croonenborgh L, Warlies F, Weeke B, Ciaccia A, Parker C. Comparison of fluticasone propionate with beclomethasone dipropionate in moderate to severe asthma treated for one-year. Thorax 1993;48:817-23.
93. Barnes NC, Marone G, Di Maria GU, Visser S, Utama I, Payne SL. A comparison of fluticasone propionate, 1 mg daily, with beclomethasone dipropionate, 2 mg daily, in the treatment of severe asthma. Eur Respir J 1993;6:877-85.
94. Gustafsson P, Tsanakas J, Gold M, Primhak R, Radford M, Gillies E. Comparison of the efficacy and safety of inhaled fluticasone propionate 200 micrograms/day with beclomethasone dipropionate 400 micrograms/day in mild and moderate asthma. Arch Dis Child 1993;69:206-11.
95. Leblanc P, Mink S, Keistinen T, Saarelainen PA, Ringdal N, Payne SL. A comparison of fluticasone propionate 200 microgTams/day with beclomethasone dipropionate 400 micrograms/day in adult asthma. Allergy 1994;49:380-5.
96. Ayres JG, Bateman ED, Lundbäck B, Harris TA. High dose fluticasone propionate, 1 mg daily, versus fluticasone propionate, 2mg daily, or budesonide, 1.6 mg daily, in patients with chronic severe asthma. Eur Respir J 1995; 8:579-86.
97. Hoekx J, Hollingworth K. A comparison of fluticasone propionate with budesonide in the treatment of children with asthma. Am J Respir Crit Care Med 1995;151(No 4 pt 2):A150.
98. Langdon CG, Thompson J. A multicentre study to compare the efficacy and safety of inhaled fluticasone propionate and budesonide via metered-dose inhalers in adults with mild-to-moderate asthma. Br J Clin Res 1994;5:73-84.
99. Steinmetz KO, Trautmann M. Efficacy of fluticasone propionate (0.5 mg daily) via MDI and budesonide (1.2 mg daily) via Turbuhaler in the treatment of steroid-naive asthmatics. Am J Respir Crit Care Med 1996;153 (Suppl) (No 4 pt 2):A330.
100. Langdon CG, Capsey LJ. Fluticasone propionate and budesonide in adult asthmatics: a comparison using dry-powder inhaler devices. Br J Clin Res 1994;5:85-99.
101. Connolly A. A comparison of fluticasone propionate 100 (ig twice daily with budesonide 200 μg twice daily via their respective powder devices in the treatment of mild asthma. Eur J Clin Res 1995;7:15-29.
102. Ringdal N, Swinburn P, Backman R, Plaschke P, Sips AP, Tell HM, Harris TA. Efficacy and safety of fluticasone propionate 800 mcg/d via the Diskhaler and budesonide 1600 mcg/d via the Turbuhaler. Am J Respir Crit Care Med 1996;153 (Suppl) (No 4 pt 2):A338.
103. Backman MD, Pickering CAC, Baumgarten C, Huskisson SC. A comparison of fluticasone propionate via Diskus (Accuhaler) inhaler and budesonide via Turbuhaler inhaler in adult asthmatics. J Allergy Clin Immunol 1996;97(No 1 Pt 3):249.
104. Williams J. Efficacy and ease of use of the fluticasone propionate multi-dose powder inhaler compared with the budesonide reservoir powder device in asthmatic children. Eur Respir J 1995;8 (Suppl 19):469s.
105. Barnes NC, Hallett C, Harris TAJ. An overview of morning peak expiratory flow rate (PEFR) for clinical trials comparing fluticasone propionate (FP) with budesonide (BUD). Eur Respir J 1996;9 (Suppl 23):52-3s.
106. Capewell S, Reynolds S, Shuttleworth D, Edwards C, Finlay AY. Purpura and dermal thinning associated with high-dose inhaled corticosteroids. BMJ 1990;300:1548-51.
107. Mak V, Melchor R, Spiro SG. Easy bruising as a side effect of inhaled corticosteroids. Eur Respir J 1992;5:1068-74.
108. Weitzman ED, Fukushima D, Nogeire C, Roffwarg H, Gallagher TF, Hellman L. Twenty-four-hour pattern of the episodic secretion of Cortisol in normal subjects. J Clin Endocrinol Metab 1971;33:14-22.
109. Brown PH, Blundell G, Greening AP, Crompton GK. Screening for hypothalamo-pituitary-adrenal axis suppression in asthmatics taking high-dose inhaled corticosteroids. Respir Med 1991;85:511-6.
110. Jennings BH. Assessment of systemic effects of inhaled glucocoticosteroids. Thesis Lund University 1990;VII:1-14.
111. Pedersen S, Fuglsang G. Urine Cortisol excretion in children treated with high-doses of inhaled corticosteroids: a comparison of budesonide and beclomethasone. Eur Respir J 1988;1:433-5.
112. Bisgaard H, Damkjaer Nielsen M, Andersen B, Andersen P, Foged N, Fuglsang G, Høst A, Leth C, Pedersen M, Pelck I, Stafanger G, Østerballe O. Adrenal function in children with bronchial asthma treated with beclomethasone dipropionate or budesonide. J Allergy Clin Immunol 1988; 81:1088-95.
113. Bisgaard H, Pedersen S, Damkjaer Nielsen M, østerballe O. Adrenal function in asthmatic children treated with inhaled budesonide. Acta Paediatr Scand 1991;80:213-17.
114. Nicolaizik WH, Marchant JL, Preece MA, Warner JO. Endocrine and lung function in asthmatic children on inhaled corticosteroids. Am J Respir Crit Care Med 1994;150:624-8.
115. Doull IJ, Freezer NJ, Holgate ST. Growth of prepubertal children with mild asthma treated with inhaled beclomethasone dipropionate. Am J Respir Crit Care Med 1995;151:1715-9.
116. Löfdahl CG, Mellstrand T, Svedmyr N. Glucocorticoids and asthma. Studies of resistance and systemic effects of glucocorticoids. Eur J Respir Dis 1984;65 (Suppl 136): 69-79.
117. Hoffmann-Streb A, L'Allemand D, Niggemann B, Buttner P, Wahn U. Adrenocortical function in children with bronchial asthma under fluticasone treatment. Monatsschr Kinderheilkd 1993;141:508-12.
118. Grahnén A, Eckemäs SA, Brundin RM, Ling-Andersson A. An assessment of the systemic activity of single doses of inhaled fluticasone propionate in healthy volunteers. Br J Clin Pharmacol 1994;38:521-5.
119. Grahnén A, Brundin RM, Ling-Andersson A, Lönnebo A, Eckernas SÅ. The systemic potency of fluticasone propionate from Diskhaler® vs budesonide from Turbuhaler®. Am J Respir Crit Care Med 1996;153 (Suppl) (No 4 pt 2):A338.
120. Grove A, Allam C, McFarlane LC, McPhate G, Lipworth BJ. A comparison of the systemic bioactivity of inhaled budesonide and fluticasone propionate in normal subjects. Br J Clin Pharmacol 1994;38:527-32.
121. Agertoft L, Pedersen S. Short terrn lower leg growth in children during treatment with fluticasone propionate and budesonide. A dose-response study. Joint Meeting of the European Society of Paediatric Allergy and Clinical Immunology (ESPACI) and European Respiratory Society Paediatric Assembly, 22-25 May 1996, Odense, Denmark. Abstract book: 57.
122. Melchor R, Biddiscombe MF, Mak VH, Short MD, Spiro SG. Lung deposition patterns of directly labelled salbutamol in normal subjects and in patients with re-versible airflow obstruction. Thorax 1993;48:506-11.
123. Boorsma M, Andersson N, Larsson P, Ullman A. Assessment of the relative systemic potency of inhaled fluticasone and budesonide. Eur Respir J 1996;9:1427-32.
124. Clark D, Grove A, Cargill RI, Lipworth BJ. Comparative adrenal suppression with inhaled budesonide and fluticasone propionate in adult asthmatic patienta Thorax 1996; 51: 262-6.
125. Clark DJ, Clark RA, Lipworth BJ. Comparative systemic bioactivity of inhaled budesonide and fluticasone propionate in asthmatic children. Br J Clin Pharmacol 1996; 42:264P.
126. Hosking DJ. Effects of corticosteroids on bone turnover. Respir Med 1993;87 (Suppl A):15-23.
127. Boyd G. Effect of inhaled corticosteroids on bone. Respir Med 1994;88 (Suppl A):45-52.
128. Adinoff AD, Hollister JR. Steroid-induced fractures and bone loss in patients with asthma. N Engl J Med 1983;309: 265-8.
129. Toogood JH, Sorva R, Puolijoki H. Review of the effects of inhaled steroid therapy on bone. Int J Risk Saf Med 1994;5:1-14.
130. Toogood JH, Hodsman A, Baskerville J, Markov A. Vertebral bone mineral density (VBMD) among elderly men and women receiving long-term inhaled (I-S) or oral steroids (O-S) for asthma. J Allergy Clin Immunol 1995;95 (No 1 pt 2):310.
131. Teelucksingh S, Padfield PL, Tibi L, Gough KJ, Holt PR. Inhaled corticosteroids, bone formation, and osteocalcin. Lancet 1991;338:60-1.
132. Pouw EM, Prummel MF, Oosting H, Roos CM, Endert E. Beclomethasone inhalation decreases serum osteocalcin concentrations. BMJ 1991;302:627-8.
133. Barnes PJ, Busse W, Pedersen S. Efficacy and safety of inhaled corticosteroids in asthma - what's new? Am J Respir Crit Care Med (in press).
134. Boulet LP, Giguere MC, Milot J, Brown J. Effects of long-term use of high-dose inhaled steroids on bone density and calcium metabolism. J Allergy Clin Immunol 1994;94: 796-803.
135. Kinberg KA, Hopp RJ, Biven RE, Gallagher JC. Bone mineral density in normal and asthmatic children. J Allergy Clin Immunol 1994;94:490-7.
136. Agertoft L, Pedersen S. Bone density in children during long-term treatment with budesonide. Eur Respir J 1993; 6:2615.
137. König P, Hillman G, Cervantes C. Bone metabolism in children with asthma treated with inhaled beclomethasone dipropionate. J Paediatr 1993;122:219-26.
138. Hopp RJ, Degan JA, Phelan J, Lappe J, Gallagher GC. Cross sectional study of bone density in asthmatic children. Paediatr Pulm 1995;20:189-92.
139. Baraldi E, Bollini MC, De Marchi A, Zacchello F. Effect of beclomethasone dipropionate on bone mineral content assessed by X-ray densitometry in asthmatic children: a longitudinal evaluation. Eur Respir J 1994;7:710-4.
140. Mattinati LC, Bertoldo F, Gasperi E, Micelli S, Boner AL. Effect on cortical and trabecular bone mass of different antiinflammatory treatments in préadolescent children with chronic asthma. Am J Respir Crit Care Med 1996; 153:232-6.
141. Sorva R, Tähtelä R, Turpeinen M, Juntunen-Backman K. Bone turnover during inhaled budesonide (BUD) in childhood asthma. Allergy Clin Immunol News 1994;6 (Suppl 2):21.
142. Kerstjens HA, Postala DS, Van Doormaal JJ, Van Zanten AK, Brand PL, Dekhuijzen PN, Koeter GH. Effects of short term and long-term treatment with inhaled corticosteroids on bone metabolism in patients with airways obstruction. Thorax 1994;49:652-6.
143. Agertoft L, Pedersen S. Bone growth and collagen markers in children treated with fluticasone propionate and budesonide. Eur Respir J 1996;9 (Suppl 23):295s.
144. Hodsman AB, Toogood JH, Jennings B, Fraher LJ, Baskerville JC. Differential effects of inhaled budesonide and oral prednisolone on serum osteocalcin. J Clin Endocrinol Metab 1991;72:530-40.
145. All NJ, Capewell S, Ward MJ. Bone turnover during high-dose inhaled corticosteroid therapy. Thorax 1991;46:160-4.
146. Leech JA, Hodder RV, Ooi DS, Gay J. Effect of short-term inhaled budesonide and beclomethasone dipropionate on serum osteocalcin in premenopausal women. Am Rev Respir Dis 1993;148:113-5.
147. Birkebaek NH, Esbjerg G, Andersen K, Wolthers O, Hassager C. Bone and collagen turnover during treatment with inhaled dry-powder budesonide and beclomethasone dipropionate. Arch Dis Child 1995;73:524-7.
148. Grove A, Mcfarlane LC, Lipworth BJ. Effects of short term exposure to inhaled corticosteroids on novel biochemical markers of bone metabolism. Eur Respir J 1995;8 (Suppl 19):303s.
149. Ninan TK, Russell G. Asthma, inhaled corticosteroid treatment, and growth. Arch Dis Child 1992;67:703-5.
150. Oberger E, Engström I, Karlberg J. Long-term treatment with glucocorticoids/ACTH in asthmatic children. III. Effects on growth and adult height. Acta Paediatr Scand 1990;79:77-83.
151. Allen DB, Mullen ML, Mullen B. A meta-analysis of the effect of oral and inhaled corticosteroids on growth. J Allergy Clin Immunol 1994;93:967-76.
152. Wolthers OD, Pedersen S. Growth of asthmatic children during treatment with budesonide: a double-blind trial. BMJ 1991;303:163-5.
153. Wolthers OD, Pedersen S. Controlled study of linear growth in asthmatic children during treatment with inhaled glucocorticosteroids. Pediatrics 1992;89:839-42.
154. Wolthers OD, Pedersen S. Short term growth during treatment with inhaled fluticasone propionate and beclomethasone dipropionate. Arch Dis Child 1993;68:673-6.
155. Wolthers OD, Pedersen S. Short term linear growth in asthmatic children during treatment with prednisolone. BMJ 1990;301:145-8.
156. MacKenzie CA, Wales JK. Growth in asthmatic children. Br Med J 1991;303:416.
157. Bisgaard H. Systemic activity from inhaled topical steroid in toddlers studied by knemometry. Acta Paed Scan 1993; 82:1066-71.
158. Agertoft L, Pedersen S. Short term lower leg growth in children during treatment with fluticasone propionate and BUD: a dose-response study. Am J Respir Crit Care Med 1995;151(No 4pt 2):A150.
159. Heuck C, Wolthers OD. Short term growth assessment of once versus twice daily inhaled budesonide in children with asthma. Eur Respir J 1995;8 (Suppl 19):470s.
160. Wolthers OD, Juul A, Hansen M, Muller J, Pedersen S. Growth factors and collagen markers in asthmatic children treated with inhaled budesonide. Eur Respir J 1993;6 (Suppl 17): 261s.
161. Tinkelman DG, Reed CE, Nelson HS, Offord KP. Aerosol beclomethasone dipropionate compared with theophylline as primary treatment of chronic, mild to moderately severe asthma in children. Pediatrics 1993; 92:64-77.
162. Hunt GJ, Edmunds AT, Kelnar CJ. Height velocity standard deviation scores in 105 pre-pubertal children receiving either beclomethasone dipropionate or budesonide. Pediatr Res 1993;33 (Suppl 5):S21.
163. Ribeiro LB. Budesonide: safety and efficacy aspects of long-term use in children. Paediatr Allergy Immunol 1993; 4:73-8.
164. Eseverri JL, Botey J, Marin AM. Budesonide: treatment of bronchial asthma during childhood. Allerg Immunol 1995;27:129-35.
165. Merkus PJ, van Essen Zandvliet EE, Duiverman EJ, van Houwelingen HC, Kerrebijn KF, Quanjer PH. Long-term effect of inhaled corticosteroids on growth rate in adolescents with asthma. Pediatrics 1993;91:1121-6.
166. Ruiz RG, Price JF. Growth and adrenal responsiveness with BUD in young asthmatics. Respir Med 1994;88:17-20.
167. Delacourt C, Chomienne F, DeBile J. Preservation of growth velocity in asthmatic children treated with high-doses of beclomethasone dipropionate. Eur Respir J 1991; 4 (Suppl 14):593s.
168. Varsano I, Volovitz B, Malik H, Amir J. Safety of 1 year of treatment with budesonide in young children with asthma. J Allergy Clin Immunol 1990;85:914-20.
169. Volovitz B, Amir J, Malik H, Kauschansky A, Varsano I. Growth and
170. MacKenzie CA, Wales JK. Clinical experience with inhaled fluticasone propionate - childhood growth. Eur Respir J 1993;6 (Suppl 17):262s.
171. Price JF, Russell G, Hindmarsh P, Weller PH, Heaf DP. One year growth velocity in asthmatic children receiving fluticasone propionate 50 μg bid or sodium cromoglycate 20 mg qid. Am J Respir Crit Care Med 1996;153 (Suppl) (No 4 pt 2):A409.
172. König P, Ford L, Galant S, Lawrence M, Lemanske R, Mendelson L, Pearlman D, Wyatt R, Allen D, Baker K, Hamedani A, Kellerman D. A 1-year comparison of the effects of inhaled fluticasone propionate (FP) and placebo on growth in prepubescent children with asthma. Eur Respir J 1996;9 (Suppl 23): 294s.
173. Toogood JH, Baskerville J, Jennings B, Lefcoe N, Johansson SÅ. Bioequivalent doses of budesonide and prednisone in moderate and severe asthma. J Allergy Clin Immunol 1989;84:688-700.