Efficacy and safety of fluticasone and formoterol in a single pressurized metered dose inhaler.
Respir Med
; 105(5): 674-82, 2011 May.
Article
em En
| MEDLINE
| ID: mdl-21196104
ABSTRACT
BACKGROUND:
Fluticasone and formoterol are well established medications for the treatment of asthma. This study (Clinicaltrials.gov identifier NCT00734318) compares the efficacy and safety of a combination of these drugs in a single inhaler (fluticasone/formoterol) versus the individual components (fluticasone + formoterol).METHODS:
Patients aged ≥ 18 years (n=620) with a history of severe, persistent reversible asthma for ≥ 6 months prior to screening were included in this randomized, double-blind study, which consisted of a screening phase of up to 5 days, a 2-week run-in phase and an 8-week treatment period.RESULTS:
Fluticasone/formoterol (500/20 µg, b.i.d.) was at least as effective as fluticasone + formoterol (500 µg + 24 µg, b.i.d.) with respect to the primary outcomemeasure:
there were similar increases in mean pre-morning dose forced expiratory volume in the first second (FEV(1)) in these two groups. Fluticasone/formoterol (500/20 µg, b.i.d.) also demonstrated similar efficacy to fluticasone + formoterol in terms of change in mean FEV(1) from baseline pre-morning dose to 2 h post-morning dose at week 8, as well as for several secondary parameters. Fluticasone/formoterol (500/20 µg, b.i.d.) demonstrated superiority to fluticasone monotherapy (500 µg, b.i.d.) and fluticasone/formoterol (100/10 µg, b.i.d.) for several secondary efficacy parameters. Fluticasone/formoterol had a similar safety and tolerability profile to fluticasone + formoterol.CONCLUSION:
This study demonstrated that the fluticasone/formoterol combination is at least as effective as its components administered concurrently from separate inhalers. Fluticasone/formoterol (500/20 µg, b.i.d.) showed superior efficacy to its inhaled corticosteroid component alone and the efficacy of fluticasone/formoterol was dose-dependent for several clinically important parameters.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Asma
/
Volume Expiratório Forçado
/
Antiasmáticos
/
Etanolaminas
/
Androstadienos
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
Limite:
Adolescent
/
Adult
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Aged
/
Aged80
/
Female
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Humans
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Male
/
Middle aged
Idioma:
En
Revista:
Respir Med
Ano de publicação:
2011
Tipo de documento:
Article