Extrafine Beclomethasone/formoterol compared to Fluticasone/salmeterol Combination Therapy in COPD

D. Singh, G. Nicolini, E. Bindi, M. Corradi, D. Guastalla, J. Kampschulte, W. Pierzchala, A. Sayiner, M. Szilasi, C. Terzano, Jørgen Vestbo, Future Foster Upgrades TherapeUtic

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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 mu g or FP/S 500/50 mu g 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.
Original languageEnglish
Article number43
JournalB M C Pulmonary Medicine
Volume14
Number of pages9
ISSN1471-2466
DOIs
Publication statusPublished - 2014

Cite this

Singh, D., Nicolini, G., Bindi, E., Corradi, M., Guastalla, D., Kampschulte, J., Pierzchala, W., Sayiner, A., Szilasi, M., Terzano, C., Vestbo, J., & TherapeUtic, F. F. U. (2014). Extrafine Beclomethasone/formoterol compared to Fluticasone/salmeterol Combination Therapy in COPD. B M C Pulmonary Medicine, 14, [43]. https://doi.org/10.1186/1471-2466-14-43