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

Dave Singh, Gabriele Nicolini, Eddi Bindi, Massimo Corradi, Daniele Guastalla, Jorg Kampschulte, Władysław Pierzchała, Abdullah Sayiner, Mária Szilasi, Claudio Terzano, Jørgen Vestbo, Jorgen Vestbo

    Research output: Contribution to journalArticlepeer-review


    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. 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. © 2014 Singh et al.; licensee BioMed Central Ltd.
    Original languageEnglish
    Article number43
    JournalBMC Pulmonary Medicine
    Issue number1
    Publication statusPublished - 12 Mar 2014


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