Research article
Dave Singh,
Gabriele Nicolini,
Eddi Bindi,
Massimo Corradi,
Daniele Guastalla,
Jorg Kampschulte,
W¿adys¿aw Pierzcha¿a,
Abdullah Sayiner,
Mária Szilasi,
Claudio Terzano and
Jørgen Vestbo
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BMC Pulmonary Medicine 2014, 14:43 doi:10.1186/1471-2466-14-43
Published: 12 March 2014
Abstract (provisional)
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 mug or FP/S 500/50 mug 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. George's Respiratory Questionnaire, six minute walking test and COPD exacerbations.
Results
BDP/FF was equivalent to FP/S in terms of TDI score and superior in terms of FEV1 change from pre-dose (p < 0.001). There were no significant differences between treatments in secondary outcome measures, confirming overall comparability in terms of efficacy and tolerability. Moreover, a clinically relevant improvement (>4 units) in SGRQ was detected in the BDP/FF group only.
Conclusion
BDP/FF extrafine combination provides COPD patients with an equivalent improvement of dyspnoea and a faster bronchodilation in comparison to FP/S.
Trial registration: ClinicalTrials.gov: NCT01245569
The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.
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