Ciclesonide versus placebo for chronic asthma in adults and children

Cochrane Database of Systematic Reviews

Volumn , Issue 2, 2008, Pages

  Manning, Pat ^a   Gibson, P G ^b   Lasserson, T J ^b  

^a BON SECOURS HOSPITAL   (Ireland)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

BECLOMETASONE; BUDESONIDE; CHOLINERGIC RECEPTOR BLOCKING AGENT; CICLESONIDE; CORTICOSTEROID; DFI 6153; FLUNISOLIDE; FLUTICASONE; FORMOTEROL; PLACEBO; PREDNISOLONE; SALMETEROL XINAFOATE; THEOPHYLLINE; TRIAMCINOLONE;

ASTHMA; CLINICAL TRIAL; DRUG DELIVERY SYSTEM; DRUG DOSE COMPARISON; FORCED EXPIRATORY VOLUME; HEADACHE; HUMAN; LUNG FUNCTION; MEDLINE; PHARYNGITIS; QUALITY OF LIFE; REVIEW; RHINITIS; RHINOPHARYNGITIS; SYMPTOMATOLOGY; THRUSH; TREATMENT DURATION; UPPER RESPIRATORY TRACT INFECTION;

EID: 45149117325     PISSN: 1469493X     EISSN: None     Source Type: Journal    
DOI: 10.1002/14651858.CD006217.pub2     Document Type: Review

References (134)

1. Adachi 2007a {published data only} Adachi M, Ishihara K, Inoue H, Kudo K, Takahashi K, Morita Y, et al.Efficacy and safety of once-daily inhaled ciclesonide in adults with mild to moderate asthma: A double-blind, placebo-controlled study. Respirology 2007;12(4):566-72.
2. Adachi 2007b {published data only} Adachi M, Ishihara K, Inoue H, Kudo K, Takahashi K, Morita Y, et al.Efficacy and safety of inhaled ciclesonide compared with chlorofluorocarbon beclomethasone dipropionate in adults with moderate to severe persistent asthma. Respirology 2007;12(4):573-80.
3. Baena Cagnani 2006 {unpublished data only} Baena-Cagnani CE, Mansfeild L, Zhang P, Lloyd M, Banjeri D. Once daily ciclesonide has no effect on growth in children with mild persistent asthma a subgroup analysis of north and South American populations. Journal of Allergy and Clinical Immunology 2006;117(2 Suppl 1):S191.
4. Bernstein D, Caballero-Fonseca F, Zhang P, Lloyd M, Banjeri D. Once daily ciclesonide has no effect on hypothalmic pituitary adrenal axis function in prepubertal children with mild persistent asthma. Journal of Allergy and Clinical Immunology 2006;117(2 Suppl 1):S184.
5. Maspero J, Maika S, Kundu S, Lloyd M, Banjerji D. Ciclesonide once daily is well tolerated in children with mild persistent asthma a 1 year double blind placebo controlled study. Journal of Allergy and Clinical Immunology 2006;117(2 Suppl 1):S94.
6. Nayak A, Herrera O, Kudu S, Lloyd M, Banjeri D. Ciclesonide has no effect on growth in prepubertal children with mild persistent asthma irrespective of age and gender. Journal of Allergy and Clinical Immunology 2006;117(2 Suppl 1):S191.
7. Neffen H, Ruff M, Zhang P, Lloyd M, Banjeri D. Ciclesonide administered once daily has no effect on skeletal maturity in prepubertal children with mild persistent asthma. Journal of Allergy and Clinical Immunology 2006;117(2 Suppl 1):S184.
8. Skoner D, Maspero J, Kundu S, Lloyd M, Banerji D. Ciclesonide administered once daily has no effect on growth velocity in prepubertal children with mild persistent asthma. Journal of Allergy and Clinical Immunology 2006;117(2 Suppl 1):S11.
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10. *Bateman E, Karpel J, Casale T, Wenzel S, Banerji D. Ciclesonide reduces the need for oral steroid use in adult patients with severe, persistent asthma. Chest 2006;129(5):1176-87.
11. Bateman 2006a {published data only} Bateman ED, Velazquez-Samano G, Záková L, Chuchalin A, Göhring UM, Engelstätter R. Comparison of ciclesonide 160 versus 640 mcg per day in patients with severe asthma. European Respiratory Journal 2006;28(50):206s.
12. Bernstein 2004 {unpublished data only} Bernstein D, Berger W, Welch M, Kundu S, Banerji D. Once-daily ciclesonide significantly improves pulmonary function in adults/adolescents with mild-moderate asthma. American Thoracic Society 2005 International Conference; May 20-25; San Diego, California. 2005:B35; poster: G27.
13. Bernstein D, Nathan R, Ledford D, Ledoux E, Pedinoff A, Crivera C, et al.Ciclesonide, a new inhaled corticosteroid, significantly improves asthma-related quality of life in patients with severe, persistent asthma. Journal of Allergy & Clinical Immunology 2005;115(2 Suppl):S210.
14. Bernstein JA, Noonan MJ, Rim C, Fish J, Kundu S, Williams J, et al.Ciclesonide has minimal oropharyngeal side effects in the treatment of patients with moderate-to-severe asthma. Journal of Allergy and Clinical Immunology 2004;113(2 Suppl):S113.
15. Busse W, Kaliner M, Bernstein D, Nayak A, Kundu S, Williams J. The novel inhaled corticosteroid ciclesonide is effacious and has a favourable safety profile in adults and adolescents with severe persistent asthma. Journal of Allergy & Clinical Immunology 2005;115(2 Suppl):S213.
16. Skoner D, Baena-Cagnani CE, Maspero J, Neffen H, Banerji D. Once-daily ciclesonide has no effect on growth velocity, as assessed by stadiometer height, in children with mild, persistent asthma. American Thoracic Society International Conference, San Diego, California, May 19-24, 2006. 2006:A73 [Poster G20].
17. Weinstein S, Friedman B, Kundu S, Banerji D. Ciclesonide is effective and well tolerated in adults/adolescents with severe persistent asthma. American Thoracic Society 2005 International Conference; May 20-25 San Diego, California. 2005:[B35] [Poster: G26].
18. Chapman 2005 {published data only} Chapman KR, Buhl R, Engelstätter R. Once daily ciclesonide is effective in the treatment of asthma. Thorax 2004;59(Suppl 2):ii71.
19. Chapman KR, D'Urzo AD, Oedekoven C, Steinijans VW, Wurst W. Effects of ciclesonide versus placebo on lung function after 12 weeks of treatment in patients with asthma. American Journal of Respiratory and Critical Care Medicine 2002;165(Suppl 8):A767.
20. Chapman KR, Patel P, Boulet LP, D'Urzo AD, Alexander M, Mehra S, et al.Efficacy and long-term safety of ciclesonide in asthmatic patients as demonstrated in a 52 week long study [abstract]. European Respiratory Society Annual Congress. 2002:Abstract nr: 2328.
21. Chapman KR, Patel P, D'Urzo AD, Alexander M, Mehra S, Oedekoven C, et al.Maintenance of asthma control by once-daily inhaled ciclesonide in adults with persistent asthma. Allergy 2005;60 (3):330-7.
22. DFI6153 {unpublished data only} Sanofi-Aventis. A placebo- and active-controlled (ciclesonide metered-dose inhaler), randomized, parallel-group, dose-range finding study of ciclesonide administered by dry powder inhaler (Ultrahaler®) in adult and adolescent patients with persistent asthma. http://www.clinicalstudyresults.org [Accessed June 2007] 2006.
23. EFC6163a {published data only} Sanofi-Aventis. A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy of ciclesonide metered-dose inhaler at a daily dose of 160 mcg administered for 12 weeks either in a once-daily regimen in the morning (160 mcg qd AM) or in a twice-daily regimen (80 mcg bid) in adults and adolescents with mild to moderate persistent asthma treated previously with inhaled corticosteroids. http://www.clinicalstudyresults.org [Accessed June 2007] 2006.
24. EFC6163b {unpublished data only} Sanofi-Aventis. A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy of ciclesonide metered-dose inhaler at a daily dose of 160 mcg administered for 12 weeks either in a once-daily regimen in the morning (160 mcg qd AM) or in a twice-daily regimen (80 mcg bid) in adults and adolescents with mild to moderate persistent asthma treated previously with inhaled corticosteroids. http://www.clinicalstudyresults.org [Accessed June 2007] 2006.
25. Gelfand 2006a {published data only} Gelfand E, Boguniweicz M, Weinstein S, Bernstein C, Lloyd M, Zhang P, et al.Ciclesonide, administered once daily, has a low incidence of oropharyngeal adverse events in pediatric asthma patients. Journal of Allergy & Clinical Immunology 2005;115(2 Suppl):S213.
26. *Gelfand EW, Georgitis JW, Noonan M, Ruff ME. Once-daily ciclesonide in children: efficacy and safety in asthma. Journal of Pediatrics 2006;148(3):377-83.
27. Kerwin E, Meltzer E, Kundo S, Banjeri D. Ciclesonide an effective once-daily inhaled corticosteroid for children with persistent asthma. American Thoracic Society 2005 International Conference; May 20-25; San Diego, California. 2005:C47; Poster: A11.
28. Miller D, Ratner P, Condemi J, Lawrence M, Crivera C, Lloyd M, et al.Once-daily ciclesonide improves quality of life in pediatric patients with asthma. Journal of Allergy & Clinical Immunology 2005;115(2 Suppl):S211.
29. Gelfand 2006b {published data only} Gelfand E, Boguniweicz M, Weinstein S, Bernstein C, Lloyd M, Zhang P, et al.Ciclesonide, administered once daily, has a low incidence of oropharyngeal adverse events in pediatric asthma patients. Journal of Allergy & Clinical Immunology 2005;115(2 Suppl):S213.
30. *Gelfand EW, Georgitis JW, Noonan M, Ruff ME. Once-daily ciclesonide in children: efficacy and safety in asthma. Journal of Pediatrics 2006;148(3):377-83.
31. Kerwin E, Meltzer E, Kundo S, Banjeri D. Ciclesonide an effective once-daily inhaled corticosteroid for children with persistent asthma. American Thoracic Society 2005 International Conference; May 20-25; San Diego, California. 2005:C47; Poster: A11.
32. Miller D, Ratner P, Condemi J, Lawrence M, Crivera C, Lloyd M, et al.Once-daily ciclesonide improves quality of life in pediatric patients with asthma. Journal of Allergy & Clinical Immunology 2005;115(2 Suppl):S211.
33. Hansel 2006 {published data only} Engelstätter R, Benezet O, Kafe H, Ponitz HH, Hansel T, Cheung D, et al.Comparative study in asthma patients treated with inhaled ciclesonide (80μg or 320μg once daily) or budesonide (200μg twice daily) for 12 weeks. American Thoracic Society 99th International Conference. 2003; Vol. C105:D64.
34. Hansel T, Biberger C, Engelstätter R. Ciclesonide 80 μg or 320 μg once daily achieves lung function improvement comparable with budesonide 200 μg twice daily in patients with persistent asthma. Thorax 2004;59(Suppl II):ii71.
35. Hansel T, Engelstatter R, Benezet O, Kafe H, Ponitz HH, Cheung D, et al.Once daily ciclesonide (80ug or 320ug) is equally effective as budesonide 200ug given twice daily: a 12 week study in asthma patients. European Respiratory Journal 2003;22(Suppl 45):Abstract No: P2639.
36. *Hansel TT, Benezet O, Kafe H, Ponitz HH, Cheung D, Engelstatter R, Barnes PJ. A multinational, 12-week, randomized study comparing the efficacy and tolerability of ciclesonide and budesonide in patients with asthma. Clinical therapeutics 2006;28(6):906-20.
37. Langdon 2005 {published data only} Drollmann A, Langdon C, Engelstätter R, Rathgeb F, Steinijans VW, Wurst W. Ciclesonide is effective in the treatment of bronchial asthma. European Respiratory Journal 2001;18(Suppl 33):95s.
38. Engelstätter R, Langdon C, Bethke T, Rathgeb F, Steinijans VW, Wurst W. Efficacy of ciclesonide after 12 week treatment of bronchial asthma. American Journal of Respiratory and Critical Care Medicine 2002;165(Suppl 8):A766.
39. *Langdon CG, Adler M, Mehra S, Alexander M, Drollmann A. Once-daily ciclesonide 80 or 320mug for 12 weeks is safe and effective in patients with persistent asthma. Respiratory Medicine 2005;99(10):1275-85.
40. Lipworth 2005 {published data only} LaForce CF, Baker JW, Amin D, Rohatagi S, Mendes P, Williams J, et al.Ciclesonide a novel inhaled steroid has no effect on hypothalamic pituitary adrenal (HPA) - axis function in mild to moderate asthmatics. Journal of Allergy and Clinical Immunology 2003;111(2 Suppl):S218.
41. *Lipworth BJ, Kaliner MA, LaForce CF, Baker JW, Kaiser HB, Amin D, et al.Effect of ciclesonide and fluticasone on hypothalamic-pituitary-adrenal axis function in adults with mild-to-moderate persistent asthma. Annals of Allergy, Asthma and Immunology 2005;94(4):465-72.
42. Magnussen 2007 {published data only} Magnussen H, Hellwig M, Hellbradt S, Josten JP, Engelstätter R. Ciclesonide 80ug or 160ug once-daily and fluticasone propionate 88ug twice-daily similarly reduce asthma symptoms and rescue medication use in patients with mild-to-moderate asthma. American Thoracic Society 2005 International Conference; May 20-25; San Diego, California. 2005:B35; Poster: G20.
43. Magnussen H, Hofman J, Novakova B, Kaczmarek B, Hellwig M, Engelstätter R. Ciclesonide 80 μg or 160 μg once daily is comparable to fluticasone propionate 88 μg twice daily in the treatment of asthma patients. European Respiratory Journal 2005;26(Suppl 49):255s.
44. Magnussen H, Hofman J, Novakova B, Kaczmarek B, Hellwig M, Engelstätter R. Ciclesonide decreases exhaled breath nitric oxide and rapidly reduces airway responsivness to adenosine monophosphate in asthma patients. European Respiratory Journal 2005;26(Suppl 49):Abstract No. 1723.
45. Magnussen H, Hofman J, Novakova B, Kaczmarek-Czeczothka B, Koci T, Staneta P, et al.Ciclesonide 80 μg or 160 μg once-daily is as effective as fluticasone propionate 88 μg twice-daily in the treatment of persistent asthma. Journal of Allergy and Clinical Immunology 2005;115(2 Suppl):S4.
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47. *Magnussen H, Hofman J, Staneta P, Lawo JP, Hellwig M, Engelstatter R. Similar efficacy of ciclesonide once daily versus fluticasone propionate twice daily in patients with persistent asthma. Journal of Asthma 2007;44(7):555-63.
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94. *Taylor DA, Jensen MW, Kanabar V, Engelstätter R, Steinijans VW, Barnes PJ, et al.A dose-dependent effect of the novel inhaled corticosteroid ciclesonide on airway responsiveness to adenosine-5′-monophosphate in asthmatic patients. American Journal of Respiratory & Critical Care Medicine 1999;160(1):237-43.
95. Arshad An assessment of safety and efficacy in treating moderate to severe asthmatics with inhaled Ciclesonide vs Fluticasone. Ongoing study Starting date of trial not provided. Contact author for more information.
96. Beck Efficacy and safety of ciclesonide administered with or without different spacers in patients with asthma (12 to 75 y). Clinicaltrials.Gov. 2005. Ongoing study Starting date of trial not provided. Contact author for more information.
97. Beckman Efficacy of ciclesonide inhaled once daily versus other corticosteroids used for treatment of mild asthma in children (4-11yrs). Clinicaltrials. Gov. 2005. Ongoing study Starting date of trial not provided. Contact author for more information.
98. Colatruglio Effect of ciclesonide on quality of life in patients with moderate persistent asthma (21 to 65 y). Clinicaltrials.Gov. 2005. Ongoing study Starting date of trial not provided. Contact author for more information.
99. Dahl Efficacy of ciclesonide versus fluticasone propionate in patients with mild to moderate asthma (12 to 75 y). Clinicaltrials.Gov. 2005. Ongoing study Starting date of trial not provided. Contact author for more information.
100. Derom Effect of inhaled ciclesonide versus fluticasone propionate in patients with mild to moderate asthma (18 to 65 y). Clinicaltrials.Gov. 2005. Ongoing study Starting date of trial not provided. Contact author for more information.
101. Dusser Efficacy of ciclesonide and fluticasone propionate in adult patients with moderate and severe persistent asthma (18 to 75 y). Clinicaltrials. Gov. 2005. Ongoing study Starting date of trial not provided. Contact author for more information.
102. Engelstätter Efficacy of ciclesonide inhaled once daily versus fluticasone propionate inhaled twice daily in children with asthma (4 to 15 y). Clinicaltrials.Gov. 2005. Ongoing study Starting date of trial not provided. Contact author for more information.
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104. Hansel A 3-period double-blind, cross-over study on the onset of action of inhaled ciclesonide on airway responsiveness to adenosine monophosphate, sputum eosinophils and exhaled breath NO in patients with asthma. Ongoing study Starting date of trial not provided. Contact author for more information.
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