Trial reportEuropean journal of clinical pharmacology2005
Lower oropharyngeal deposition of inhaled ciclesonide via hydrofluoroalkane metered-dose inhaler compared with budesonide via chlorofluorocarbon metered-dose inhaler in healthy subjects.
Trial report in European journal of clinical pharmacology, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it, 57 citations in OpenAlex.
- Inhaled ciclesonide versus inhaled budesonide or inhaled beclomethasone or inhaled fluticasone for chronic asthma in adults: a systematic review.BMC family practice · 2006Pooled it
- Effect of coadministered ketoconazole, a strong cytochrome P450 3A4 enzyme inhibitor, on the pharmacokinetics of ciclesonide and its active metabolite desisobutyryl-ciclesonide.Clinical pharmacokinetics · 2008Trial
- Equivalent pharmacokinetics of the active metabolite of ciclesonide with and without use of the AeroChamber Plus spacer for inhalation.Clinical pharmacokinetics · 2006Trial
- Oral candidiasis caused by ciclesonide in a patient with COVID-19 pneumonia: A case report and literature review.SAGE open medical case reports · 2021Article
- Inhalational Ciclesonide found beneficial in prevention of fat embolism syndrome and improvement of hypoxia in isolated skeletal trauma victims.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2017Article
- Inhaled corticosteroids and the occurrence of oral candidiasis: a prescription sequence symmetry analysis.Drug safety · 2013Article
- From inhaler to lung: clinical implications of the formulations of ciclesonide and other inhaled corticosteroids.International journal of general medicine · 2013Article
- Adrenal suppression: A practical guide to the screening and management of this under-recognized complication of inhaled corticosteroid therapy.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2011Article
- Similar Results in Children with Asthma for Steady State Pharmacokinetic Parameters of Ciclesonide Inhaled with or without Spacer.Clinical medicine insights. Pediatrics · 2010Article
- Management of asthma in adults.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2009Review
- Ciclesonide: a safe and effective inhaled corticosteroid for the treatment of asthma.Journal of asthma and allergy · 2009Article
- Clinical pharmacokinetic and pharmacodynamic profile of inhaled ciclesonide.Clinical pharmacokinetics · 2009Review
- Metabolism of ciclesonide in the upper and lower airways: review of available data.Journal of asthma and allergy · 2008Article
- Review
- In vitro metabolism of beclomethasone dipropionate, budesonide, ciclesonide, and fluticasone propionate in human lung precision-cut tissue slices.Respiratory research · 2007Article
- Ciclesonide for the treatment of asthma.Therapeutics and clinical risk management · 2006Article
- Ciclesonide in persistent asthma: the evidence of its therapeutic value.Core evidence · 2006Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveInhaled corticosteroids may cause oropharyngeal side effects if deposited in the oropharynx in active form. Ciclesonide, an inhaled corticosteroid with low glucocorticoid receptor affinity, is activated primarily in the lung by esterases to an active metabolite, desisobutyryl-ciclesonide (des-CIC), with high glucocorticoid receptor affinity. We studied oropharyngeal deposition of ciclesonide, des-CIC, and budesonide.
methodsIn an open-label, randomized, two-treatment (administered in sequence), five-period study, 18 healthy subjects received 800 microg (ex-valve) inhaled ciclesonide via a hydrofluoroalkane-pressurized, metered-dose inhaler followed by 800 microg budesonide (Pulmicort) by a chlorofluorocarbon-pressurized, metered-dose inhaler (four puffs of 200 microg each, ex-valve) or vice versa. Oropharyngeal cavity rinsing was performed immediately, or 15, 30, 45, or 60 min after inhalation (one rinsing per study period), and the solutions were analyzed using liquid chromatography with tandem mass spectrometric detection.
resultsCiclesonide and budesonide were detected in most oropharyngeal wash samples. Maximal concentration of each inhaled corticosteroid was reached immediately post-inhalation; maximal concentrations of ciclesonide and des-CIC were 30% and 0.67%, respectively, of budesonide. Oropharyngeal deposition of ciclesonide and budesonide decreased rapidly within 15 min post-inhalation, and less rapidly thereafter. Less than 10% of the residual ciclesonide in the oropharynx was converted to des-CIC. The molar dose-adjusted amount of des-CIC was 4% of budesonide (P < 0.0001). There were no significant adverse events.
conclusionOropharyngeal deposition of des-CIC was more than one order of magnitude lower than that of budesonide when administered by the respective metered-dose inhalers. This may explain the low frequency of oropharyngeal side effects of ciclesonide in clinical studies.
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