Efficacy and safety of ciclesonide in patients with severe asthma: A 12-week, double-blind, randomized, parallel-group study with long-term (1-year) follow-up

Expert Opinion on Pharmacotherapy

Volumn 11, Issue 17, 2010, Pages 2791-2803

  O'Connor, Brian J ^a   Kilfeather, Stephen ^b   Cheung, David ^c   Kafé, Henri ^d   Blagden, Mark D ^e   Schlsser, Nol ^f   Ayres, Jon G ^g   Weber, Hans Jochen ^h   Engelsttter, Renate ^h  

^a KING'S COLLEGE LONDON   (United Kingdom)

^b Bioscience Centre   (United Kingdom)

^c Vlietland Hospital   (Netherlands)

^d Cabinet de Pneumologie   (France)

^e Avondale Surgery   (United Kingdom)

^f CENTRAL MILITARY HOSPITAL   (Netherlands)

^g UNIVERSITY OF ABERDEEN   (United Kingdom)

^h Nycomed GmbH   (Germany)

Author keywords

Asthma; Ciclesonide; Cortisol; Lung function

Indexed keywords

CICLESONIDE;

ADULT; AGED; ARTICLE; ASTHMA; BRONCHITIS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; FLU LIKE SYNDROME; FOLLOW UP; FORCED EXPIRATORY VOLUME; FORCED VITAL CAPACITY; HEMATOMA; HUMAN; HYDROCORTISONE BLOOD LEVEL; HYDROCORTISONE URINE LEVEL; LUNG FUNCTION; MAJOR CLINICAL STUDY; MALE; PEAK EXPIRATORY FLOW; PHARYNGITIS; RANDOMIZED CONTROLLED TRIAL; RHINITIS; SIDE EFFECT; SINUSITIS; SORE THROAT; TASTE DISORDER; THRUSH; UPPER RESPIRATORY TRACT INFECTION; VOICE CHANGE;

ADMINISTRATION, INHALATION; ADULT; AGED; ANTI-ASTHMATIC AGENTS; ASTHMA; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; FOLLOW-UP STUDIES; FORCED EXPIRATORY VOLUME; HUMANS; HYDROCORTISONE; MALE; MIDDLE AGED; PREGNENEDIONES;

EID: 78149422843     PISSN: 14656566     EISSN: None     Source Type: Journal    
DOI: 10.1517/14656566.2010.526603     Document Type: Article

References (36)

1. Barnes P. Inhaled glucocorticoids for asthma. N Eng J Med 1995;332:868-75
2. Barnes PJ, Pedersen S, Busse W. Efficacy and safety of inhaled corticosteroids: new developments. Am J Respir Crit Care Med 1998;157(3 Suppl 2):S1-53
3. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention. Revised 2007. Available from: www.ginasthma.org .. Current guidelines for diagnosis, prevention and management of asthma.
4. National Institutes of Health: National Heart, Lung, and Blood Institute. National Asthma Education and Prevention Program. Expert Panel Report
5. 3: Guidelines for the diagnosis and management of asthma, 2007. NIH publication no. 07-4051. Available from: www.nhlbi.nih.gov .. Current guidelines for diagnosis, prevention and management of asthma.
6. The BTS/SIGN British Guideline on the Management of Asthma, 2007. Available from: www.sign.ac.uk .. Current guidelines for diagnosis, prevention and management of asthma.
7. Lipworth B. Systemic adverse effects of inhaled corticosteroid therapy: a systematic review and meta-analysis. Arch Intern Med 1999;159:941-55
8. Toogood JH. Side effects of inhaledcorticosteroids. J Allergy Clin Immunol 1998;102(5):705-13
9. Cave A, Arlett P, Lee E. Inhaled and nasal corticosteroids: factors affecting the risks of systemic adverse effects. Pharmacol Ther 1999;83(3):153-79
10. Hanania N, Chapman K, Kesten S. Adverse effects of inhaled corticosteroids. Am J Med 1995;98(Februrary):196-208 . This review explores the adverse effects associated with inhaled corticosteroids including oropharyngeal candidiasis, dysphonia and adrenal suppression.
11. Derendorf H, Nave R, Drollmann A, et al. Relevance of pharmacokinetics and pharmacodynamics of inhaled corticosteroids to asthma. Eur Respir J 2006;28(5):1042-50
12. Rohatagi S, Arya V, Zech K, et al. Population pharmacokinetics and pharmacodynamics of ciclesonide. J Clin Pharmacol 2003;43(4):365-78
13. Newman S, Salmon A, Nave R, Drollmann A. High lung deposition of 99mTc-labeled ciclesonide administered via HFA-MDI to patients with asthma. Respir Med 2006;100(3):375-84
14. Leach CL, Bethke TD, Boudreau RJ, et al. Two-dimensional and three-dimensional imaging show ciclesonide has high lung deposition and peripheral distribution: a nonrandomized study in healthy volunteers. J Aerosol Med 2006;19(2):117-26
15. Nave R. Clinical pharmacokinetic and pharmacodynamic profile of inhaled ciclesonide. Clin Pharmacokinet 2009;48(4):243-52
16. Richter K, Kanniess F, Biberger C, et al. Comparison of the oropharyngeal deposition of inhaled ciclesonide and fluticasone propionate in patients with asthma. J Clin Pharmacol 2005;45(2):146-52
17. Chapman KR, Patel P, DUrzo AD, et al. Maintenance of asthma control by once-daily inhaled ciclesonide in adults with persistent asthma. Allergy 2005;60(3):330-7
18. Langdon CG, Adler M, Mehra S, et al. Once-daily ciclesonide 80 or 320 g for 12 weeks is safe and effective in patients with persistent asthma. Respir Med 2005;99(10):1275-85
19. Pearlman D, Berger W, Kerwin E, et al. Once-daily ciclesonide improves lung function and is well tolerated by patients with mild-to-moderate persistent asthma. J Allergy Clin Immunol 2005;116(6):1206-12
20. Bateman ED, Cheung D, Lapa e Silva J, et al. Randomized comparison of ciclesonide 160 and 640 microg/day in severe asthma. Pulm Pharmacol Ther 2008;21(3):489-98
21. American Thoracic Society. Standardization of spirometry 1994 update. Am J Resp Crit Care Med 1995;152:1107-36
22. Guidelines for the evaluation of impairment/disability in patients with asthma. American Thoracic Society. Medical Section of the American Lung Association. Am Rev Respir Dis 1993;147(4):1056-61
23. DAlonzo GE, Steinijans VW, Keller A. Measurements of morning and evening airflow grossly underestimate the circadian variability of FEV1 and peak expiratory flow rate in asthma. Am J Respir Crit Care Med 1995;152(3):1097-9
24. Szefler SJ, Martin RJ, King TS, et al. Significant variability in response to inhaled corticosteroids for persistent asthma. J Allergy Clin Immunol 2002;109(3):410-18
25. Bateman E, Karpel J, Casale T, et al. Ciclesonide reduces the need for oral steroid use in adult patients with severe, persistent asthma. Chest 2006;129(5):1176-87
26. World Medical Association. World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. Available at: 30publications/10policies/b3/index.html (Accessed 12 October 2010)
27. GINA. Global Initiative for Asthma. National Institutes of Health, National Heart, Lung and Blood Institute; 2005. Available at: . ginasthma.com/GuidelinesResources.asp? l1=2&l2=0 (Accessed 12 October 2010)
28. Leach CL, Davidson PJ, Hasselquist BE, Boudreau RJ. Lung deposition of hydrofluoroalkane-134a beclomethasone is greater than that of chlorofluorocarbon fluticasone and chlorofluorocarbon beclomethasone : a cross-over study in healthy volunteers. Chest 2002;122(2):510-16
29. Engelstaetter R, Escher A, Haefner D. Low incidence of oropharyngeal adverse events in asthma patients treated with ciclesonide. Eur Respir J 2005;26(Suppl 49):255s
30. Nave R, Zech K, Bethke TD. Lower oropharyngeal deposition of inhaled ciclesonide via hydrofluoroalkane metered-dose inhaler compared with budesonide via chlorofluorocarbon metered-dose inhaler in healthy subjects. Eur J Clin Pharmacol 2005;61(3):203-8
31. Harrison T, Wisniewski A, Honour J, Tattersfield A. Comparison of the systemic effects of fluticasone propionate and budesonide given by dry powder inhaler in healthy and asthmatic subjects. Thorax 2001;56:186-91
32. Martin RJ, Szefler SJ, Chinchilli VM, et al. Systemic effect comparisons of six inhaled corticosteroid preparations. Am J Respir Crit Care Med 2002;165(10):1377-83
33. Weinbrenner A, Huneke D, Zschiesche M, et al. Circadian rhythm of serum cortisol after repeated inhalation of the new topical steroid ciclesonide. J Clin Endocrinol Metab 2002;87(5):2160-3
34. Postma DS, Sevette C, Martinat Y, et al. Treatment of asthma by the inhaled corticosteroid ciclesonide given either in the morning or evening. Eur Respir J 2001;17(6):1083-8
35. Vermeulen JH, Gyurkovits K, Rauer H, Engelstatter R. Randomized comparison of the efficacy and safety of ciclesonide and budesonide in adolescents with severe asthma. Respir Med 2007;101(10):2182-91
36. Derom E, Van De Velde V, Marissens S, et al. Effects of inhaled ciclesonide and fluticasone propionate on cortisol secretion and airway responsiveness to adenosine 5¢monophosphate in asthmatic patients. Pulm Pharmacol Ther 2005;18(5):328-36