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.
Expert Opin Pharmacother
; 11(17): 2791-803, 2010 Dec.
Article
em En
| MEDLINE
| ID: mdl-20958119
ABSTRACT
OBJECTIVE:
To investigate the efficacy and safety of ciclesonide in patients with severe asthma over a 1-year period. RESEARCH DESIGN ANDMETHODS:
Patients aged 18 - 75 years with persistent asthma were enrolled in a 12-week, double-blind, randomized study and treated with ciclesonide 320 or 640 µg twice daily (b.i.d.) with the option of continuing in a 40-week extension phase (EP). MAIN OUTCOMESMEASURES:
Change in morning peak expiratory flow (PEF) from baseline to 12 weeks and safety over 1 year.RESULTS:
365 patients were randomized and 275 continued into the EP. During 12 weeks' treatment, morning peak expiratory flow significantly increased by 16 l/min (p < 0.001) and 14 l/min (p = 0.001) in the 320 and 640 µg b.i.d. groups, respectively. Both doses significantly reduced total asthma symptom scores by 0.29 (p < 0.0001). In both groups, the incidence of adverse effects (AEs) was low and mean cortisol levels in serum and urine were not suppressed during the EP.CONCLUSIONS:
Ciclesonide 320 µg b.i.d. sustained lung function and asthma symptoms in patients with severe asthma over 12 weeks' treatment, and maintained lung function during a 40-week EP; ciclesonide 640 µg b.i.d. did not provide additional benefits. Long-term use of ciclesonide was not associated with increased local AEs or negative effects on cortisol levels.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Pregnenodionas
/
Asma
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Antiasmáticos
Tipo de estudo:
Clinical_trials
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Observational_studies
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Prognostic_studies
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Risk_factors_studies
Limite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2010
Tipo de documento:
Article