Extrafine beclomethasone/formoterol compared to fluticasone/salmeterol combination therapy in COPD.

ABSTRACT:

Background

The study evaluated the efficacy of beclomethasone dipropionate/formoterol fumarate (BDP/FF) extrafine combination versus fluticasone propionate/salmeterol (FP/S) combination in COPD patients.

Methods

The trial was a 12-week multicentre, randomised, double-blind, double dummy study; 419 patients with moderate/severe COPD were randomised to BDP/FF 200/12 μg or FP/S 500/50 μg twice daily. The primary objective was to demonstrate the equivalence between treatments in terms of Transition Dyspnoea Index (TDI) score and the superiority of BDP/FF in terms of change from pre-dose in the first 30 minutes in forced expiratory volume in the first second (FEV1). Secondary endpoints included lung function, symptom scores, symptom-free days and use of rescue medication, St. Geo

SUBMITTER: Singh D 

PROVIDER: S-EPMC4008134 | biostudies-literature | 2014 Mar

REPOSITORIES: biostudies-literature