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

Bj, O'Connor; Kilfeather, S.; Cheung, D.; Kafé, H; Blagden,; Schlösser, N. J. J.; Ayres, JG; Hj, Weber; Engelstätter, Renate

doi:10.1517/14656566.2010.526603

Cited by 9 publications

(9 citation statements)

References 29 publications

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“…Among the all cases, (70%) had family history of asthma with 46.6% positive history of atopy. [6][7][8] Symptoms evaluated for, were wheezing, breathlessness, cough, sputum production, and nocturnal symptoms showed significant improvement at the end of 2 nd month and further improvement at the end of 6 th month. β 2 -agonist has been known to relax airway smooth muscle and enhance mucociliary clearance and decrease vascular permeability and modulate mediator release as well.…”

Section: Discussionmentioning

confidence: 98%

Comparative efficacy of inhaled ciclesonide, budesonide, and fluticasone in mild to moderately persistent bronchial asthma

Maiti

Naser

Panda

et al. 2014

Int J Basic Clin Pharmacol

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Section: Discussionmentioning

confidence: 98%

Comparative efficacy of inhaled ciclesonide, budesonide, and fluticasone in mild to moderately persistent bronchial asthma

Maiti

Naser

Panda

et al. 2014

Int J Basic Clin Pharmacol

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“…Evidence from a separate 12-week randomized, double-blind study suggests that ciclesonide 640 µg/day is close to the top of the dose-response curve, at least in terms of lung function and asthma symptom score [49]. Morning PEF increased significantly from baseline with both 320 µg b.i.d.…”

Section: Efficacy Of High-dose Ciclesonidementioning

confidence: 93%

“…and 640 µg b.i.d. in patients with severe asthma recorded no cases of patient-reported oral candidiasis [49]. A separate 24-week study comparing ciclesonide 320 µg b.i.d.…”

Section: Local Adverse Eventsmentioning

confidence: 97%

“…Clinical trials of the efficacy of ciclesonide in patients with severe asthma have utilized b.i.d. dosing when the total dose is >320 µg/day (Table 1) [20,[44][45][46][47][48][49]. These studies have reported improved outcomes with high-versus lowdose ciclesonide, although none of the studies compared high-dose ciclesonide administered as an q.d.…”

Section: Dosing Frequency and Time Of Dosing Of High-dose Ciclesonidementioning

confidence: 99%

“…Studies of ciclesonide doses of up to 1280 µg/day report no clinically relevant suppression of HPA-axis function and minimal associated AEs (Figure 3) [39,44,46,48,49,[54][55][56][57][58]. For example, a 12-week study of ciclesonide 320 µg b.i.d and 640 µg b.i.d.…”

Section: Systemic Adverse Eventsmentioning

confidence: 99%

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

Bateman¹

2013

Expert Review of Respiratory Medicine

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Asthma severity is classified according to the level of treatment required to control symptoms. Inhaled corticosteroids are the recommended first-line therapy for the treatment of persistent asthma, and when asthma remains uncontrolled, one option is to increase the inhaled corticosteroids dose. However, there is a concomitant risk of increasing local and systemic adverse events, which may impact patient adherence and physician prescribing practices. Ciclesonide is delivered as a prodrug, has high peripheral lung deposition and high protein-binding capabilities, and is rapidly eliminated from the systemic circulation. This article reviews the use of high-dose ciclesonide in patients with severe asthma and considers whether the pharmacology of ciclesonide translates into it being an efficacious and well-tolerated option for patients requiring a step-up in their asthma treatment.

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Duration of Pediatric Clinical Trials Submitted to the US Food and Drug Administration

et al. 2019

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IMPORTANCE The increasing prevalence of pediatric chronic disease has resulted in increased exposure to long-term drug therapy in children. The duration of recently completed drug trials that support approval for drug therapy in children with chronic diseases has not been systematically evaluated. Such information is a vital first step in forming safety pharmacovigilance strategies for drugs used for long-term therapy in children. OBJECTIVE To characterize the duration of clinical trials submitted to the US Food and Drug Administration (FDA) for pediatric drug approvals, with a focus on drugs used for long-term therapy. DESIGN AND SETTING A review was performed of all safety and efficacy clinical trials conducted under the Best Pharmaceuticals for Children Act or the Pediatric Review Equity Act and submitted to the FDA from September 1, 2007, to December 31, 2014, to support the approval of drugs frequently used for long-term therapy in children. Statistical analysis was performed from July 1, 2015, to December 31, 2017. MAIN OUTCOMES AND MEASURES Maximum duration of trials submitted to support FDA approval of drugs for children. RESULTS A total of 306 trials supporting 86 drugs intended for long-term use in children were eligible for the primary analysis. The drugs most commonly evaluated were for treatment of neurologic (25 [29%]), pulmonary (16 [19%]), and anti-infective (14 [16%]) indications. The median maximum trial duration by drug was 44 weeks (minimum, 1.1 week; maximum, 364 weeks). For nearly two-thirds of the drugs (52 [61%]), the maximum trial duration was less than 52 weeks. For 10 of the drugs (12%), the maximum trial duration was 3 years or more. Maximum duration of trials did not vary by therapeutic category, minimum age of enrollment, calendar year, or legislative mandate. CONCLUSIONS AND RELEVANCE Pediatric clinical trials designed to sufficiently investigate drug safety and efficacy to support FDA approval are of relatively limited duration. Given the potential long-term exposure of patients to these drugs, the clinical community should consider whether new approaches are needed to better understand the safety associated with long-term use of these drugs.

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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

Cited by 9 publications

References 29 publications

Comparative efficacy of inhaled ciclesonide, budesonide, and fluticasone in mild to moderately persistent bronchial asthma

Comparative efficacy of inhaled ciclesonide, budesonide, and fluticasone in mild to moderately persistent bronchial asthma

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

Duration of Pediatric Clinical Trials Submitted to the US Food and Drug Administration

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