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001-es BibID:	BIBFORM024370
Első szerző:	Pedersen, Søren
Cím:	Efficacy and safety of ciclesonide once daily and fluticasone propionate twice daily in children with asthma / Søren Pedersen, Renate Engelstätter, Hans-Jochen Weber, Sabine Hirsch, László Barkai, Andrej Emeryk, Heinrich Weber, Jan Vermeulen
Dátum:	2009
Megjegyzések:	Background: Ciclesonide is a new inhaled corticosteroid (ICS). Information about its clinical efficacy and safety in relation to other ICS in children is needed for clinical positioning. Objective: This 12-week, randomized, double-blind, double-dummy, three-arm, parallel-group study compared the efficacy and safety of ciclesonide with fluticasone propionate in children with mainly moderate and severe persistent asthma. Methods: Seven hundred and forty-four patients (aged 6-11 years) were randomized to ciclesonide (80 or 160 ?g once daily) or fluticasone propionate (88 ?g twice daily), following a 2-4-week run-in. Efficacy measurements included forced expiratory flow in 1 s (FEV<sub>1</sub>), morning peak expiratory flow (PEF), asthma symptom scores, rescue medication use and quality of life. Systemic effect was assessed by 24-hour urine free cortisol adjusted for creatinine. Results: FEV<sub>1</sub> and morning PEF increased from baseline in all groups (p < 0.0001). Ciclesonide 160 ?g was not inferior to fluticasone propionate 176 ?g for FEV<sub>1</sub> (p = 0.0030, one-sided). In all groups, asthma symptom score sums and rescue medication use significantly improved (p < 0.0001). The percentages of asthma symptom-, rescue medication- and nocturnal awakening-free days were high, with no significant differences between treatments. Quality of life scores improved with all treatments (p < 0.0001). A significant dose-response occurred between low and higher doses of ciclesonide for exacerbations and asthma control definitions. The incidences of adverse events were comparable across treatments. Urine free cortisol levels decreased significantly with fluticasone propionate (p = 0.0103), but not with ciclesonide. Conclusion: Once-daily ciclesonide has a clinical effect similar to that of fluticasone propionate, but does not suppress cortisol excretion, in children with moderate and severe asthma. ? 2008 Elsevier Ltd. All rights reserved. PubMed ID: 19141327 UR: http://www.scopus.com/inward/record.url?eid=2-s2.0-67349207839&partnerID=40&md5=d6f76a2546d13a0796a4ec07ffcae279 http://www.scopus.com/record/display.url?origin=inward&eid=2-s2.0-67349207839
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban Treatment Outcome Quality of Life Pregnenediones Methacholine Chloride Male Lung hydrocortisone Humans Forced Expiratory Volume Female Double-Blind Method Dose-Response Relationship, Drug Chronic Disease Child Bronchoconstrictor Agents Asthma Anti-Asthmatic Agents Androstadienes unspecified side effect thrush scoring system school child randomized controlled trial priority journal preschool child peak expiratory flow major clinical study lung function test hydrocortisone urine level human forced expiratory flow drug withdrawal drug safety drug efficacy double blind procedure dose response disease severity disease exacerbation controlled study controlled clinical trial clinical trial ARTICLE salbutamol methacholine Fluticasone propionate creatinine Ciclesonide SAFETY Inhaled corticosteroids Hypothalamic-pituitary-adrenal axis EFFICACY CHILDREN
Megjelenés:	Pulmonary pharmacology & therapeutics. - 22 : 3 (2009), p. 214-220. -
További szerzők:	Engelstätter, Renate Weber, Hans-Jochen Hirsch, Sabine Barkai László (1958-) (gyermekgyógyász) Emeryk, Andrej Weber, Heinrich Vermeulen, Jan
Internet cím:	DOI Intézményi repozitóriumban (DEA) tárolt változat
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