Efficacy and safety of three ciclesonide doses vs placebo in children with asthma: the RAINBOW study.
Respir Med
; 104(11): 1618-28, 2010 Nov.
Article
en En
| MEDLINE
| ID: mdl-20619624
ABSTRACT
OBJECTIVE:
To evaluate the efficacy and safety of three doses of ciclesonide (with or without spacer) in children with persistent asthma. PATIENTS ANDMETHODS:
This was a multicentre, double-blind, placebo-controlled, 12-week study of ciclesonide 40, 80 or 160 µg (once daily pm). Children (6-11 years) were randomised 11 to treatment via a metered dose inhaler (MDI) or MDI plus spacer. The primary variable was change from baseline in mean morning peak expiratory flow (PEF). Secondary variables included time to first lack of efficacy (LOE), asthma control, forced expiratory volume in 1 s (FEV(1)), asthma symptom score and quality of life (QoL). Safety assessments included adverse events (AEs), urinary cortisol excretion and body height.RESULTS:
In total, 1073 children received treatment. At endpoint, mean morning PEF significantly improved with all doses of ciclesonide vs. placebo. There was no difference over placebo in time to first LOE, but ciclesonide was superior to placebo on asthma control, symptom score, FEV(1) and QoL. There were no differences between the spacer or non-spacer subgroups. The incidences of AEs were comparable between treatment groups (approximately 35%) and there were no between-group differences in body height or urinary cortisol.CONCLUSIONS:
Ciclesonide 40-160 µg once daily is effective and well tolerated in children with persistent asthma; its efficacy and safety are unaffected by the use of a spacer. clinicaltrials.gov registration number NCT00384189.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Pregnenodionas
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Pruebas de Función Respiratoria
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Asma
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Hidrocortisona
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Antiinflamatorios
Tipo de estudio:
Clinical_trials
Límite:
Child
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Female
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Humans
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Male
Idioma:
En
Revista:
Respir Med
Año:
2010
Tipo del documento:
Article
País de afiliación:
Dinamarca