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

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...

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Autores principales: Singh, Dave, Nicolini, Gabriele, Bindi, Eddi, Corradi, Massimo, Guastalla, Daniele, Kampschulte, Jorg, Pierzchała, Władysław, Sayiner, Abdullah, Szilasi, Mária, Terzano, Claudio, Vestbo, Jørgen
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4008134/
https://www.ncbi.nlm.nih.gov/pubmed/24621109
http://dx.doi.org/10.1186/1471-2466-14-43
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author Singh, Dave
Nicolini, Gabriele
Bindi, Eddi
Corradi, Massimo
Guastalla, Daniele
Kampschulte, Jorg
Pierzchała, Władysław
Sayiner, Abdullah
Szilasi, Mária
Terzano, Claudio
Vestbo, Jørgen
author_facet Singh, Dave
Nicolini, Gabriele
Bindi, Eddi
Corradi, Massimo
Guastalla, Daniele
Kampschulte, Jorg
Pierzchała, Władysław
Sayiner, Abdullah
Szilasi, Mária
Terzano, Claudio
Vestbo, Jørgen
author_sort Singh, Dave
collection PubMed
description 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 (FEV(1)). 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 FEV(1) 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
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spelling pubmed-40081342014-05-03 Extrafine Beclomethasone/formoterol compared to Fluticasone/salmeterol Combination Therapy in COPD Singh, Dave Nicolini, Gabriele Bindi, Eddi Corradi, Massimo Guastalla, Daniele Kampschulte, Jorg Pierzchała, Władysław Sayiner, Abdullah Szilasi, Mária Terzano, Claudio Vestbo, Jørgen BMC Pulm Med Research Article 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 (FEV(1)). 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 FEV(1) 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 BioMed Central 2014-03-12 /pmc/articles/PMC4008134/ /pubmed/24621109 http://dx.doi.org/10.1186/1471-2466-14-43 Text en Copyright © 2014 Singh et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited.
spellingShingle Research Article
Singh, Dave
Nicolini, Gabriele
Bindi, Eddi
Corradi, Massimo
Guastalla, Daniele
Kampschulte, Jorg
Pierzchała, Władysław
Sayiner, Abdullah
Szilasi, Mária
Terzano, Claudio
Vestbo, Jørgen
Extrafine Beclomethasone/formoterol compared to Fluticasone/salmeterol Combination Therapy in COPD
title Extrafine Beclomethasone/formoterol compared to Fluticasone/salmeterol Combination Therapy in COPD
title_full Extrafine Beclomethasone/formoterol compared to Fluticasone/salmeterol Combination Therapy in COPD
title_fullStr Extrafine Beclomethasone/formoterol compared to Fluticasone/salmeterol Combination Therapy in COPD
title_full_unstemmed Extrafine Beclomethasone/formoterol compared to Fluticasone/salmeterol Combination Therapy in COPD
title_short Extrafine Beclomethasone/formoterol compared to Fluticasone/salmeterol Combination Therapy in COPD
title_sort extrafine beclomethasone/formoterol compared to fluticasone/salmeterol combination therapy in copd
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4008134/
https://www.ncbi.nlm.nih.gov/pubmed/24621109
http://dx.doi.org/10.1186/1471-2466-14-43
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