A multinational, 12-week, randomized study comparing the efficacy and tolerability of ciclesonide and budesonide in patients with asthma

Hansel, Trevor T.; Benezet, O; Kafé, H; Ponitz, Hans-Hermann; Cheung, D.; Engelstätter, Renate; Barnes, Peter J.

doi:10.1016/j.clinthera.2006.06.014

Cited by 38 publications

(21 citation statements)

References 30 publications

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“…The efficacy of once-daily dosing with ciclesonide has been indicated in a number of clinical trials in children, adolescents and adults with asthma in comparison with placebo, BUD and FP [78][79][80][81]. Furthermore, several clinical trials have demonstrated a low incidence of oropharyngeal candidiasis and no appreciable adverse effect on endogenous cortisol secretion after short-and long-term treatment of asthma with ciclesonide at doses ranging 80-1,280 mg (ex-actuator) [82][83][84][85][86][87][88].…”

Section: Modern and Emerging Inhaled Corticosteroidsmentioning

confidence: 99%

Relevance of pharmacokinetics and pharmacodynamics of inhaled corticosteroids to asthma

Derendorf

Nave²,

Drollmann

et al. 2006

European Respiratory Journal

216

182

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The pharmacokinetic and pharmacodynamic effects of inhaled corticosteroids (ICS) have shaped the efficacy and safety of these agents in the treatment of asthma.Important pharmacokinetic and pharmacodynamic characteristics that can enhance the efficacy of ICS include small particle size, high glucocorticoid-receptor-binding affinity, long pulmonary residence time and lipid conjugation. These characteristics can increase or prolong the antiinflammatory effects of an ICS. Important pharmacokinetic characteristics that can enhance the safety of ICS include on-site activation in the lung, low oropharyngeal exposure, negligible oral bioavailability, high protein-binding and rapid systemic clearance.The degree of oropharyngeal exposure is relevant to local side-effects, such as oropharyngeal candidiasis, dysphonia and coughing. Pharmacokinetic properties that influence the degree of systemic exposure are relevant to the pharmacodynamic effect of ICS-induced hypothalamicpituitary-adrenal axis suppression and cortisol suppression, an indicator of potential long-term systemic side-effects, such as reduced growth velocity and bone density, fractures, and skin bruising and thinning.Therefore, significant differences in the pharmacokinetic and pharmacodynamic characteristics of the currently available inhaled corticosteroids warrant careful consideration when used in clinical practice as they may result in differences in efficacy and local and systemic safety profiles.

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Section: Modern and Emerging Inhaled Corticosteroidsmentioning

confidence: 99%

Relevance of pharmacokinetics and pharmacodynamics of inhaled corticosteroids to asthma

Derendorf

Nave²,

Drollmann

et al. 2006

European Respiratory Journal

216

182

View full text Add to dashboard Cite

show abstract

“…For example, in a 12-week study enrolling patients with mild to moderate asthma, an FEV 1 increase of almost 0.4 L after 3 months of treatment with 160 µg ciclesonide daily was reported [6]. Another randomized study reported a median improvement of FEV 1 of 11 % after 3 months of treatment with 80 µg ciclesonide once daily in a study [21]. However, since Santanello et al [22] determined the average minimal patient perceivable improvement in FEV 1 in clinical asthma trials as 0.23 L, the results of the current study indicate that the observed increase of FEV 1 can be regarded as clinically meaningful.…”

Section: Final Assessment Of Ciclesonide By the Investigatormentioning

confidence: 93%

Effectiveness and safety of ciclesonide in the treatment of patients with persistent allergic or non-allergic asthma in medical practice (Data from a non-interventional study conducted in Austria)

Burghuber

Köberl

Lenk-Feik³

et al. 2014

Wien Klin Wochenschr

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“…47 FP serving as "an active comparator" and "to maintain blinding integrity" was "delivered at a 37% higher dose." Significant doserelated improvements in FEV 1 were observed in the CIC 160 g (110 mL), CIC 320 g (180 mL), and the FP 440 g (240 mL) twice daily groups compared with the placebo group.…”

Section: Ciclesonide Efficacymentioning

confidence: 99%

Advances in inhaled corticosteroid pharmacology

Zitt

2007

allergy asthma proc

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Inhaled corticosteroids have been the backbone of asthma therapy for the past 20 plus years. Although they have, for the most part, been effective in controlling asthma symptoms and preventing exacerbations, not all patients are universally responsive to their beneficial effects. In addition, several recent studies have failed to demonstrate a disease-modifying effect of inhaled corticosteroids, with clinically indicated doses failing to prevent long term deterioration in lung function and potential airway "remodeling". Furthermore, it is apparent that possible side effects are still a concern with currently available formulations. Steroid characteristics, which might improve the therapeutic index of this class of medicine by enhancing efficacy while minimizing side effects, are explored, with special emphasis on the molecule, ciclesonide.

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A multinational, 12-week, randomized study comparing the efficacy and tolerability of ciclesonide and budesonide in patients with asthma

Cited by 38 publications

References 30 publications

Relevance of pharmacokinetics and pharmacodynamics of inhaled corticosteroids to asthma

Relevance of pharmacokinetics and pharmacodynamics of inhaled corticosteroids to asthma

Effectiveness and safety of ciclesonide in the treatment of patients with persistent allergic or non-allergic asthma in medical practice (Data from a non-interventional study conducted in Austria)

Advances in inhaled corticosteroid pharmacology

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