Clinical models to compare the safety and efficacy of inhaled corticosteroids in patients with asthma

Canadian Respiratory Journal

Volumn 10, Issue 1, 2003, Pages 27-34

  Parameswaran, K ^a   Leigh, Richard ^a   O'Byrne, Paul M ^a   Kelly, Margaret M ^a   Goldsmith, Charlie H ^b   Hargreave, Frederick E ^a   Dolovich, Myrna ^a  

^a Firestone Institute for Respiratory Health   (Canada)

^b MCMASTER UNIVERSITY   (Canada)

Author keywords

Asthma; Clinical models; Efficacy; Inhaled corticosteroids; Outcomes; Relative potency; Safety

Indexed keywords

ADENOSINE PHOSPHATE; ALLERGEN; BECLOMETASONE; BECLOMETASONE DIPROPIONATE; BUDESONIDE; CHLOROFLUOROCARBON; CICLESONIDE; CORTICOSTEROID; FLUNISOLIDE; FLUORINATED HYDROCARBON; FLUTICASONE; FLUTICASONE PROPIONATE; GENERIC DRUG; HYDROCORTISONE; METHACHOLINE; MOMETASONE FUROATE; OSTEOCALCIN; PLACEBO; PREDNISONE; STEROID; TRIAMCINOLONE ACETONIDE;

AIRWAY DYNAMICS; AREA UNDER THE CURVE; ASTHMA; BIOEQUIVALENCE; BIOLOGICAL MODEL; BRONCHUS; CLINICAL TRIAL; CROSSOVER PROCEDURE; DEVICE; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG EFFICACY; DRUG FORMULATION; DRUG POTENCY; DRUG SAFETY; EXERCISE; EXHALATION; HUMAN; MATHEMATICAL MODEL; METERED DOSE INHALER; PARTICLE SIZE; PRIORITY JOURNAL; RESPIRATORY TRACT INFLAMMATION; REVIEW; SIDE EFFECT; SPIROMETRY; SPUTUM ANALYSIS; SYMPTOMATOLOGY; TREATMENT OUTCOME;

EID: 0037254073     PISSN: 11982241     EISSN: None     Source Type: Journal    
DOI: 10.1155/2003/813972     Document Type: Review

References (50)

1. Barnes PJ. Inhaled corticosteroids for asthma. N Engl J Med 1995;332:868-75.
2. Pedersen S, O'Byrne P. A comparison of the efficacy and safety of inhaled corticosteroids in asthma. Allergy 1997;52(Suppl 39):1-34.
3. Chrystyn H. Methods to identify drug deposition in the lungs following inhalation. Br J Clin Pharmacol 2001;51:289-99.
4. Boulet LP, Cockcroft DW, Toogood J, Lacasse Y, Baskerville J, Hargreave FE. Comparative assessment of safety and efficacy of inhaled corticosteroids: Report of a committee of the Canadian Thoracic Society. Eur Respir J 1998;11:1194-210.
5. Parameswaran K. Concepts of establishing clinical bioequivalence of chlorofluorocarbon and hydrofluoroalkane beta-agonists. J Allergy Clin Immunol 1999;104:243-5.
6. Hatala R, Holbrook A, Goldsmith CH. Therapeutic equivalence: All studies are not created equal. Can J Clin Pharmacol 1999;6:9-11.
7. Zanen P, Lammers JW. Sample sizes for comparative inhaled corticosteroid trials with emphasis on showing therapeutic equivalence. Eur J Clin Pharmacol 1995;48:179-84.
8. 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 1999;104:1215-22.
9. Jatakanon A, Kharitonov S, Lim S, Barnes PJ. Effect of differing doses of inhaled budesonide on markers of airway inflammation in patients with mild asthma. Thorax 1999;54:108-14.
10. Wilson AM, Lipworth BJ. Dose-response evaluation of the therapeutic index for inhaled budesonide in patients with mild-to-moderate asthma. Am J Med 2000;108:269-75.
11. Pedersen S, Hansen OR. Budesonide treatment of moderate and severe asthma in children: A dose-response study. J Allergy Clin Immunol 1995;95:29-33.
12. Finney DJ. Statistical Methods in Biological Assay, 3rd edn. London: Charles Griffin and Co Ltd, 1978.
13. Kamada AK, Szefler SJ. How should inhaled corticosteroids be compared? J Allergy Clin Immunol 1997;99:735-7.
14. Basran G, Scott R, Campbell M, et al. A study to compare the efficacy of budesonide (Pulmicort Turbuhaler) and fluticasone propionate (Flixotide Diskhaler) in the treatment of asthma. Thorax 1995;50:469P. (Abst)
15. Dahl R, Lundback B, Malo JM, et al. A dose-ranging study of fluticasone propionate in adult patients with moderate asthma. Chest 1993;104:1352-8.
16. Fabbri L, Burge PS, Croonenborgh L, et al. Comparison of fluticasone propionate with beclomethasone dipropionate in moderate to severe asthma treated for one year. Thorax 1993;48:817-23.
17. Barnes NC, Marone G, Di Maria GU, et al. 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.
18. Cockcroft DW, Swystun VA. Asthma control versus asthma severity. J Allergy Clin Immunol 1996;98:1016-8.
19. Ryan G, Latimer KM, Dolovich J, Hargreave FE. Bronchial responsiveness to histamine: relationship to diurnal variation of peak flow rate, improvement after bronchodilator, and airway calibre. Thorax 1982;37:423-9.
20. Parameswaran K, Inman MD, Watson R, et al. Protective effects of fluticasone on allergen-induced airway responses and sputum inflammatory markers. Can Respir J 2000;7:313-9.
21. Wong BJ, Dolovich J, Ramsdale EH, et al. Formoterol compared with beclomethasone and placebo on allergen-induced asthmatic responses. Am Rev Respir Dis 1992;146:1156-60.
22. Cockcroft DW, McParland CM, O'Byrne PM, et al. Beclomethasone given after the early asthmatic response inhibits the late response and the increase methacholine responsiveness and cromolyn does not. J Allergy Clin Immunol 1993;91:1163-8.
23. Gauvreau GM, Doctor J, Watson RM, Jordana M, O'Byrne PM. Effects of inhaled budesonide on allergen-induced airway responses and airway inflammation. Am J Respir Crit Care Med 1996;154:1267-71.
24. Kidney JC, Cockcroft DW, Hargreave FE, Boulet LP, Jennings B. Evaluation of inhaled corticosteroid activity using single doses and allergen challenge model. J Allergy Clin Immunol 1997;100:65-70.
25. Swystun VA, Bhagat R, Kalra S, Jennings B, Cockcroft DW. Comparison of three different doses of budesonide and placebo on the allergen-induced early asthmatic response. J Allergy Clin Immunol 1998;102:363-7.
26. Inman MD, Watson RM, Rerecich T, et al. Dose-dependent effects of inhaled mometasone furoate on airway function and inflammation after allergen inhalation challenge. Am J Respir Crit Care Med 2001;164:569-74.
27. Woolcock AJ, Yan K, Salome CM. Effect of therapy on bronchial hyperresponsiveness in the long-term management of asthma. Clin Exp Allergy 1988;18:165-76.
28. Taylor DA, Jensen MW, Kanabar V, et al. A dose-dependent effect of the novel inhaled corticosteroid ciclesonide on airway responsiveness to adenosine-5′-monophosphate in asthmatic patients. Am J Respir Crit Care Med 1999;160:237-43.
29. Ketchell RI, Jensen MW, Lumley P, Allenby M, Costello JF, O'Connor BJ. Rapid effect of a single dose of inhaled fluticasone propionate on airway responsiveness to AMP in mild asthma. Am J Respir Crit Care Med 2001;163:A420.
30. Lipworth BJ. Systemic adverse effects of inhaled corticosteroid therapy: A systematic review and meta-analysis. Arch Intern Med 1999;159:941-55.
31. Sorkness CA. Establishing a therapeutic index for the inhaled corticosteroids: Comparisons of systemic activity and safety among different inhaled corticosteroids. J Allergy Clin Immunol 1998;102:S52-64.
32. Nielsen LP, Dahl R. Therapeutic ratio of inhaled corticosteroids in adult asthma: A dose-range comparison between fluticasone propionate and budesonide, measuring their effect on bronchial hyperresponsiveness and adrenal cortex function. Am J Respir Crit Care Med 2000;162:2053-7.
33. Lipworth BJ, Seckl JR. Measures for detecting systemic bioactivity with inhaled and intranasal corticosteroids. Thorax 1997;52:476-82.
34. Martin RJ, Szefler SJ, Chinchilli VM, et al. Systemic effect comparisons of six inhaled corticosteroid preparations. Am J Respir Crit Care Med 2002;165:1377-83.
35. Donnelly R, Williams KM, Baker AB, Badcock CA, Day RO, Seale JP. Effects of budesonide and fluticasone on 24-hour plasma cortisol. A dose-response study. Am J Respir Crit Care Med 1997;156:1746-51.
36. Ahrens RC, Teresi ME, Han SH, Donnell D, Vanden Burgt JA, Lux CR. Asthma stability after oral prednisone: A clinical model for comparing inhaled steroid potency. Am J Respir Crit Care Med 2001;164:1138-45.
37. Hargreave FE. Induced sputum and response to glucocorticoids. J Allergy Clin Immunol 1998;102:S102-5.
38. Kelly MM, Leigh R, Parameswaran K, et al. Establishing dose-response and relative potencies of inhaled corticosteroids. Am J Respir Crit Care Med 2001;163:A518.
39. Boulet LP, Becker AB, Berube D, Beveridge R, Ernst P, on behalf of the Canadian Asthma Consensus Group. Canadian Asthma Consensus Report. CMAJ 1999;161:S1-61.
40. Agertoft L, Pedersen S. A randomized, double-blind dose reduction study to compare the minimal effective dose of budesonide Turbuhaler and fluticasone propionate Diskhaler. J Allergy Clin Immunol 1997;99:773-80.
41. Derendorf H, Hochhaus G, Meibohm B, Mollmann H, Barth J. Pharmacokinetics and pharmacodynamics of inhaled corticosteroids. J Allergy Clin Immunol 1998;102:S440-6.
42. Dolovich M, Rhem R, Rashid F, Coates G, Hill M, Bowen B. Measurement of the particle size and dosing characteristics of a radiolabeled albuterol-sulphate lactose blend used in the SPIROS7 dry powder inhaler. Respiratory Drug Delivery V, Interpharm Press, 1996:332-5.
43. Dolovich M. In Vitro Measurements of Delivery of Medications from MDIs and Spacer Devices. Proceedings of In Vitro/In Vivo Standards of Measurement for MDIs Workshop, Atlanta GE. J Aerosol Med 1996;9(Suppl 1):S49-S58.
44. Derendorf H, Daley-Yates PT, Pierre LN, Efthimiou J. Systemic bioavailability of inhaled steroids: The importance of appropriate and comparable methodology. Eur Respir J 2001;17:157-8.
45. Fowler SJ, Orr LC, Wilson AM, Sims EJ, Lipworth BJ. Dose response for adrenal supression with hydrofluoroalkane formulations of fluticasone propionate and beclomethasone dipropionate. Br J Clin Pharmacol 2001;52:93-5.
46. Dolovich M. Measuring total and regional lung deposition using inhaled radiotracers. J Aerosol Med 2001;14(Suppl 1):S35-S44.
47. Milanowski J, Qualtrough J, Perrin VL. Inhaled beclomethasone (BDP) with non-CFC propellant (HFA 134a) is equivalent to BDP-CFC for the treatment of asthma. Respir Med 1999;93:245-51.
48. Farmer IS, Middle M, Savic J, PErrin VL, Herdman MJ. Therapeutic evidence of inhaled beclamethasone dipropionate with CFC and non-CFC (HFA 134a) proellants delivered via the Easibreathe inhaler for the treatment of paediatric asthma. Respir Med 2000;94:57-63.
49. Dolovich M, Rhem R, GErrard L, Coates G. Lung deposition of coarse CFC vs fine HFA pMDI aerosols of beclomethasone dipropionate (BDP0 in asthma. Am J Respir Crit Care Med 2000;151:A33. (Abst)
50. Pedersen, S. Choosing the best inhaled drug delivery system for school children. In International Respiratory Forum: Current Perspectives in Inhaled Drug Therapy. Reading: Colwood House Medical Publications (UK) Ltd, 1995:28.