346
Views
5
CrossRef citations to date
0
Altmetric
Drug Profile

Efficacy and safety of high-dose ciclesonide for the treatment of severe asthma

Pages 339-348 | Published online: 09 Jan 2014

References

  • National Heart, Lung, and Blood Institute Expert Panel Report 3. Guidelines for the Diagnosis and Management of Asthma. (2007).
  • Powell H, Gibson PG. Inhaled corticosteroid doses in asthma: an evidence-based approach. Med. J. Aust. 178(5), 223–225 (2003).
  • Bateman ED, Boushey HA, Bousquet J et al. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study. Am. J. Respir. Crit. Care Med. 170(8), 836–844 (2004).
  • Wisnivesky JP, Lorenzo J, Lyn-Cook R et al. Barriers to adherence to asthma management guidelines among inner-city primary care providers. Ann. Allergy Asthma Immunol. 101(3), 264–270 (2008).
  • Foster JM, Smith L, Bosnic-Anticevich SZ et al. Identifying patient-specific beliefs and behaviours for conversations about adherence in asthma. Intern. Med. J. 42(6), e136–e144 (2012).
  • Holgate ST, Polosa R. The mechanisms, diagnosis, and management of severe asthma in adults. Lancet 368(9537), 780–793 (2006).
  • To T, Stanojevic S, Moores G, et al. Global asthma prevalence in adults: findings from the cross-sectional world health survey. BMC Public Health 12, 204 (2012).
  • Siroux V, Pin I, Oryszczyn MP, Le MN, Kauffmann F. Relationships of active smoking to asthma and asthma severity in the EGEA study. Epidemiological study on the Genetics and Environment of Asthma. Eur. Respir. J. 15(3), 470–477 (2000).
  • Tomlinson JE, McMahon AD, Chaudhuri et al. Efficacy of low and high dose inhaled corticosteroid in smokers versus non-smokers with mild asthma. Thorax 60(4), 282–287 (2005).
  • Pedersen SE, Bateman ED, Bousquet J, et al. Determinants of response to fluticasone propionate and salmeterol/fluticasone propionate combination in the Gaining Optimal Asthma controL study. J. Allergy Clin. Immunol. 120(5), 1036–1042 (2007).
  • Bateman ED, Reddel HK, Eriksson G, et al. Overall asthma control: the relationship between current control and future risk. J. Allergy Clin. Immunol. 125(3), 600–608, 608.e1 (2010).
  • O’Byrne PM. Therapeutic strategies to reduce asthma exacerbations. J. Allergy Clin. Immunol. 128(2), 257–263 (2011).
  • Harrison TW, Oborne J, Newton S, et al. Doubling the dose of inhaled corticosteroid to prevent asthma exacerbations: randomised controlled trial. Lancet 363(9405), 271–275 (2004).
  • Fitzgerald JM, Becker A, Sears MR, et al. Doubling the dose of budesonide versus maintenance treatment in asthma exacerbations. Thorax 59(7), 550–556 (2004).
  • Oborne J, Mortimer K, Hubbard RB, et al. Quadrupling the dose of inhaled corticosteroid to prevent asthma exacerbations: a randomized, double-blind, placebo-controlled, parallel-group clinical trial. Am. J. Respir. Crit. Care Med. 180(7), 598–602 (2009).
  • Guest JF, Davie AM, Ruiz FJ, et al. Switching asthma patients to a once-daily inhaled steroid improves compliance and reduces healthcare costs. Prim. Care Respir. J. 14(2), 88–98 (2005).
  • Mutch E, Nave R, McCracken N, et al. The role of esterases in the metabolism of ciclesonide to desisobutyryl-ciclesonide in human tissue. Biochem. Pharmacol. 73(10), 1657–1664 (2007).
  • Dahl R. Systemic side effects of inhaled corticosteroids in patients with asthma. Respir. Med. 100(8), 1307–1317 (2006).
  • 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. 45(2), 146–152 (2005).
  • Bateman ED, Linnhof AE, Homik L, et al. Comparison of twice-daily inhaled ciclesonide and fluticasone propionate in patients with moderate-to-severe persistent asthma. Pulm. Pharmacol. Ther. 21(2), 264–275 (2008).
  • 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. 61(3), 203–208 (2005).
  • Derendorf H, Nave R, Drollmann A, et al. Relevance of pharmacokinetics and pharmacodynamics of inhaled corticosteroids to asthma. Eur. Respir. J. 28(5), 1042–1050 (2006).
  • Martin RJ. Therapeutic significance of distal airway inflammation in asthma. J. Allergy Clin. Immunol. 109(Suppl. 2), S447–S460 (2002).
  • 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. 19(2), 117–126 (2006).
  • Newman S, Salmon A, Nave R, et al. High lung deposition of 99mTc-labeled ciclesonide administered via HFA-MDI to patients with asthma. Respir. Med. 100(3), 375–384 (2006).
  • Cohen J, Douma WR, ten Hacken NH, et al. Ciclesonide improves measures of small airway involvement in asthma. Eur. Respir. J. 31(6), 1213–1220 (2008).
  • Hoshino M. Comparison of effectiveness in ciclesonide and fluticasone propionate on small airway function in mild asthma. Allergol. Int. 59(1), 59–66 (2010).
  • Nave R, Bethke TD, van Marle SP, et al. Pharmacokinetics of [14C]ciclesonide after oral and intravenous administration to healthy subjects. Clin. Pharmacokinet. 43(7), 479–486 (2004).
  • 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(3), 201–209 (2005).
  • Nonaka T, Nave R, McCracken N, et al. Ciclesonide uptake and metabolism in human alveolar type II epithelial cells (A549). BMC Pharmacol. 7, 12 (2007).
  • Boulet LP, Bateman ED, Voves R, et al. A randomized study comparing ciclesonide and fluticasone propionate in patients with moderate persistent asthma. Respir. Med. 101(8), 1677–1686 (2007).
  • Dahl R, Engelstatter R, Trebas-Pietras E, et al. A 24-week comparison of low-dose ciclesonide and fluticasone propionate in mild to moderate asthma. Respir. Med. 104(8), 1121–1130 (2010).
  • Buhl R, Vinkler I, Magyar P et al. Comparable efficacy of ciclesonide once daily versus fluticasone propionate twice daily in asthma. Pulm. Pharmacol. Ther. 19(6), 404–412 (2006).
  • Pincus DJ, Szefler SJ, Ackerson LM, et al. Chronotherapy of asthma with inhaled steroids: the effect of dosage timing on drug efficacy. J. Allergy Clin. Immunol. 95(6), 1172–1178 (1995).
  • Pincus DJ, Humeston TR, Martin RJ. Further studies on the chronotherapy of asthma with inhaled steroids: the effect of dosage timing on drug efficacy. J. Allergy Clin. Immunol. 100(6 Pt 1), 771–774 (1997).
  • Zetterstrom O, Dahl R, Lindqvist A, et al. Comparable morning versus evening administration of once-daily mometasone furoate dry powder inhaler. Respir. Med. 102(10), 1406–1411 (2008).
  • Meibohm B, Hochhaus G, Rohatagi S, et al. Dependency of cortisol suppression on the administration time of inhaled corticosteroids. J. Clin. Pharmacol. 37(8), 704–710 (1997).
  • 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. 17(6), 1083–1088 (2001).
  • Derom E, Van DV, 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. 18(5), 328–336 (2005).
  • Masoli M, Weatherall M, Beasley R. Fluticasone given once versus twice a day: meta-analysis. Respirology 10(2), 183–188 (2005).
  • Selroos O, Edsbacker S, Hultquist C. Once-daily inhaled budesonide for the treatment of asthma: clinical evidence and pharmacokinetic explanation. J. Asthma 41(8), 771–790 (2004).
  • Toogood JH, Baskerville JC, Jennings B, et al. Influence of dosing frequency and schedule on the response of chronic asthmatics to the aerosol steroid, budesonide. J. Allergy Clin. Immunol. 70(4), 288–298 (1982).
  • Malo JL, Cartier A, Merland N, et al. Four-times-a-day dosing frequency is better than a twice-a-day regimen in subjects requiring a high-dose inhaled steroid, budesonide, to control moderate to severe asthma. Am. Rev. Respir. Dis. 140(3), 624–628 (1989).
  • Bateman E, Karpel J, Casale T, et al. Ciclesonide reduces the need for oral steroid use in adult patients with severe, persistent asthma. Chest 129(5), 1176–1187 (2006).
  • Adachi M, Ishihara K, Inoue H, et al. Efficacy and safety of inhaled ciclesonide compared with chlorofluorocarbon beclomethasone dipropionate in adults with moderate to severe persistent asthma. Respirology 12(4), 573–580 (2007).
  • Vermeulen JH, Gyurkovits K, Rauer H, et al. Randomized comparison of the efficacy and safety of ciclesonide and budesonide in adolescents with severe asthma. Respir. Med. 101(10), 2182–2191 (2007).
  • 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. 21(3), 489–498 (2008).
  • van den Berge M, Arshad SH, Ind PW, et al. Similar efficacy of ciclesonide versus prednisolone to treat asthma worsening after steroid tapering. Respir. Med. 103(8), 1216–1223 (2009).
  • O’Connor BJ, Kilfeather S, Cheung D, et al. 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 Opin. Pharmacother. 11(17), 2791–2803 (2010).
  • Kelly HW. Inhaled corticosteroid dosing: double for nothing? J. Allergy Clin. Immunol. 128(2), 278.e2–281.e2 (2011).
  • van der Molen T, Foster JM, Caeser M, et al. Difference between patient-reported side effects of ciclesonide versus fluticasone propionate. Respir. Med. 104(12), 1825–1833 (2010).
  • Kelly HW, Sternberg AL, Lescher R et al.; CAMP Research Group. Effect of inhaled glucocorticoids in childhood on adult height. N. Engl. J. Med. 367(10), 904–912 (2012).
  • Peters SP. Safety of inhaled corticosteroids in the treatment of persistent asthma. J. Natl. Med. Assoc. 98(6), 851–861 (2006).
  • Szefler S, Rohatagi S, Williams J, et al. Ciclesonide, a novel inhaled steroid, does not affect hypothalamic-pituitary-adrenal axis function in patients with moderate-to-severe persistent asthma. Chest 128(3), 1104–1114 (2005).
  • Lipworth BJ, Short PM, Williamson PA, et al. A randomized primary care trial of steroid titration against mannitol in persistent asthma: STAMINA trial. Chest 141(3), 607–615 (2012).
  • Anderson WJ, McFarlane LC, Lipworth BJ. Prospective follow-up of novel markers of bone turnover in persistent asthmatics exposed to low and high doses of inhaled ciclesonide over 12 months. J. Clin. Endocrinol. Metab. 97(6), 1929–1936 (2012).
  • Agertoft L, Pedersen S. Lower-leg growth rates in children with asthma during treatment with ciclesonide and fluticasone propionate. Pediatr. Allergy Immunol. 21(1 Pt 2), e199–e205 (2010).
  • Chylack LT Jr, Gross GN, Pedinoff A; Ciclesonide Lenticular Safety Study Group. A randomized, controlled trial to investigate the effect of ciclesonide and beclomethasone dipropionate on eye lens opacity. J. Asthma 45(10), 893–902 (2008).
  • Heller MK, Laks J, Kovesi TA, et al. Reversal of adrenal suppression with ciclesonide. J. Asthma 47(3), 337–339 (2010).
  • Fahy JV. Eosinophilic and neutrophilic inflammation in asthma: insights from clinical studies. Proc. Am. Thorac. Soc. 6(3), 256–259 (2009).
  • Spears M, Cameron E, Chaudhuri R, et al. Challenges of treating asthma in people who smoke. Expert Rev. Clin. Immunol. 6(2), 257–268 (2010).
  • Shaw DE, Green RH, Bradding P. Asthma exacerbations: prevention is better than cure. Ther. Clin. Risk Manag. 1(4), 273–277 (2005).
  • Green RH, Brightling CE, McKenna S, et al. Asthma exacerbations and sputum eosinophil counts: a randomised controlled trial. Lancet 360(9347), 1715–1721 (2002).
  • Petsky HL, Cates CJ, Lasserson TJ et al. A systematic review and meta-analysis: tailoring asthma treatment on eosinophilic markers (exhaled nitric oxide or sputum eosinophils). Thorax 67(3), 199–208 (2012).
  • O’Byrne PM, Pedersen S, Carlsson LG et al. Risks of pneumonia in patients with asthma taking inhaled corticosteroids. Am. J. Respir. Crit. Care Med. 183(5), 589–595 (2011).
  • Hojo M, Iikura M, Hirano S, et al. Increased risk of nontuberculous mycobacterial infection in asthmatic patients using long-term inhaled corticosteroid therapy. Respirology 17(1), 185–190 (2012).
  • Andrejak C, Nielsen R, Thomsen VO, et al. Chronic respiratory disease, inhaled corticosteroids and risk of non-tuberculous mycobacteriosis. Thorax 68(3), 256–262 (2013).
  • Zhang L, Prietsch SO, Mendes AP et al. Inhaled corticosteroids increase the risk of oropharyngeal colonization by Streptococcus pneumoniae in children with asthma. Respirology 18(2), 272–277 (2013).
  • Janson C, Larsson K, Lisspers K, and Stalberg B. Pneumonia in COPD patients treated with fixed ICS/LABA combinations. ERS Vienna Abstract 2897 (2012).
  • Chen D, Restrepo MI, Fine MJ et al. Observational study of inhaled corticosteroids on outcomes for COPD patients with pneumonia. Am. J. Respir. Crit. Care Med. 184(3), 312–316 (2011).
  • Korn S, Buhl R. Efficacy of a fixed combination of ciclesonide and formoterol: the EXCITED-study. Respir. Med. 106(1), 57–67 (2012).
  • Thomson NC, Chaudhuri R, Spears M. Emerging therapies for severe asthma. BMC Med. 9, 102 (2011).
  • Pavord ID, Korn S, Howarth P et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet 380(9842), 651–659 (2012).
  • Vestbo J, Tan L, Atkinson G, Ward J. A controlled trial of 6-weeks’ treatment with a novel inhaled phosphodiesterase type-4 inhibitor in COPD. Eur. Respir. J. 33(5), 1039–1044 (2009).
  • Kerstjens HA, Engel M, Dahl R et al. Tiotropium in asthma poorly controlled with standard combination therapy. N. Engl. J. Med. 367(13), 1198–1207 (2012).

Website

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.