Ciclesonide, a Novel Inhaled Steroid, Does Not Affect Hypothalamic-Pituitary-Adrenal Axis Function in Patients With Moderate-to-Severe Persistent Asthma

Szefler, Stanley J.; Rohatagi, Shashank; Williams, J. E.; Lloyd, Mark; Kundu, Sudeep; Banerji, Donald

doi:10.1378/chest.128.3.1104

Cited by 91 publications

(61 citation statements)

References 38 publications

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“…This needs further assessment in long-term studies including other safety parameters. The lack of effect of ciclesonide on cortisol excretion in this study corroborates the findings in other studies in children, 8,28 as well as adults, [14][15][16][17] in which minimal effects on the hypothalamic-pituitary-adrenal-axis were seen. Both drugs were well tolerated in the study and the AE rates were low, with similar profiles for the two drugs.…”

Section: Discussionsupporting

confidence: 92%

“…[8][9][10][11][12][13] Furthermore, ciclesonide was well tolerated in these populations. 8,9,[14][15][16][17][18][19] An earlier comparison of ciclesonide versus fluticasone propionate in children, using only one dose of each drug indicated similar efficacy of the two drugs. 9 To further investigate the efficacy and safety of ciclesonide, the present study included bronchial hyperresponsiveness and definitions of asthma control using combinations of outcome measures, in addition to more traditional measures.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Efficacy and safety of ciclesonide once daily and fluticasone propionate twice daily in children with asthma

Pedersen¹,

Engelstätter²,

Weber³

et al. 2009

Pulmonary Pharmacology & Therapeutics

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Section: Discussionsupporting

confidence: 92%

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of ciclesonide once daily and fluticasone propionate twice daily in children with asthma

Pedersen¹,

Engelstätter²,

Weber³

et al. 2009

Pulmonary Pharmacology & Therapeutics

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“…Previous studies have shown that ciclesonide does not induce cortisol suppression at daily doses as high as 1280 µg. [28,29] Similarly, budesonide 400 µg once daily did not demonstrate significant cortisol suppression in healthy subjects or patients with asthma. [30,31] In another study, twice-daily budesonide 200 µg (400 µg per day) was shown to significantly suppress urinary cortisol compared with once-daily ciclesonide 320 µg (p<0.05).…”

Section: Accepted Manuscriptmentioning

confidence: 93%

Ciclesonide is more effective than budesonide in the treatment of persistent asthma

Ukena

Biberger²,

Steinijans³

et al. 2007

Pulmonary Pharmacology & Therapeutics

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Background: Ciclesonide is a lung-activated inhaled corticosteroid that provides effective control of persistent asthma. The objective of this study was to compare the efficacy and safety of once-daily ciclesonide versus once-daily budesonide in patients with asthma. Methods:A total of 399 patients with asthma were randomised to receive once-daily ciclesonide 320 µg ex-actuator (equivalent to 400 µg ex-valve) or once-daily budesonide 400 µg for 12 weeks. The primary endpoint was forced expiratory volume in 1 second (FEV 1 ). Additional efficacy variables included forced vital capacity (FVC), peak expiratory flow (PEF), asthma symptoms, use of rescue medication and time to onset of effect. Adverse events were monitored throughout the study. Conclusion:Once-daily ciclesonide was more effective than once-daily budesonide in improving FEV 1 , FVC and PEF. Ciclesonide also had an earlier onset of action than budesonide in patients with persistent asthma. Both ciclesonide and budesonide had good safety and tolerability profiles.

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“…Both these actions have as a result an altered transcription of pro-and anti-inflammatory genes. The main pharmacokinetic/dynamic properties [9][10][11] depend on (a) receptor affinity [12]; (b) particle size and formulation [13,14]; (c) oral, pulmonary, and systemic bioavailability [15][16][17][18]; (d) half-life [17]; (e) protein binding [19]; (f) bioactivation [17,20]; (g) lipophilicity; (h) lipid conjugation [8]; and (i) metabolism [17].…”

Section: Pharmacokinetics and Pharmacodynamics Of Icssmentioning

confidence: 99%

Erratum to: Safety Considerations of Inhaled Corticosteroids in the Elderly

et al. 2015

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Inhaled corticosteroids (ICSs) are widely used in the treatment of patients with chronic obstructive pulmonary diseases. However, high-dose regimens and longterm use of ICSs have the potential to cause a variety of local and systemic side effects such as candidiasis, cataracts, glaucoma, and osteoporosis. The use of ICSs can also be associated with the risk of bone fractures, diabetes mellitus and pneumonia. These ICS-related side effects are of particular importance in elderly patients due to the presence of comorbidities and age-related behavioral, cognitive, and psychological problems, which can all interact with inhaled treatment. We reviewed the available literature on the clinically relevant side effects of ICSs in the elderly to provide practical measures to properly monitor and manage the risk of ICSs in the geriatric population. Inspection of the mouth, monitoring of ocular pressure, and use of bone-protective drugs may be necessary in patients on prolonged ICS therapy. Above all, the use of the lowest possible ICS dose and a careful re-assessment of the inhalation procedure should be recommended. Taken together, these observations suggest that physicians should use ICSs appropriately for those patients in whom the benefit will outweigh the risk, especially chronic obstructive pulmonary disease (COPD) patients with previous frequent exacerbations. Given the paucity of information on the topic and the need to extrapolate the results from studies with broader age ranges, we strongly encourage the design of specifically tailored clinical studies in the elderly. Key PointsAsthma and chronic obstructive pulmonary disease (COPD) are inflammatory disorders of the airways. The pharmacological management of these chronic diseases is based on persistent and long-term use of inhaled corticosteroids (ICSs).Asthma and COPD are among the most common chronic diseases in clinical settings, and physicians are expected to diagnose and manage those diseases in the geriatric population on a daily basis. The management of chronic obstructive respiratory diseases in the geriatric population is complicated by the increased occurrence of comorbidities and associated treatment, and by age-associated physiological and structural changes of the lung.The chronic use of ICSs in the elderly is associated with the increased risk of local and systemic side effects such as candidiasis, cataract, glaucoma, diabetes mellitus, bone fractures, and pneumonia. Physicians should be aware of this in order to select those patients in whom the benefits will outweigh the risks.The online version of the original article can be found under

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Ciclesonide, a Novel Inhaled Steroid, Does Not Affect Hypothalamic-Pituitary-Adrenal Axis Function in Patients With Moderate-to-Severe Persistent Asthma

Cited by 91 publications

References 38 publications

Efficacy and safety of ciclesonide once daily and fluticasone propionate twice daily in children with asthma

Efficacy and safety of ciclesonide once daily and fluticasone propionate twice daily in children with asthma

Ciclesonide is more effective than budesonide in the treatment of persistent asthma

Erratum to: Safety Considerations of Inhaled Corticosteroids in the Elderly

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