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The efficacy of extrafine beclomethasone dipropionate–formoterol fumarate in COPD patients who are not "frequent exacerbators": a post hoc analysis of the FORWARD study

Authors Singh D, Vezzoli S, Petruzzelli S, Papi A

Received 9 May 2017

Accepted for publication 4 October 2017

Published 3 November 2017 Volume 2017:12 Pages 3263—3271


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 3

Editor who approved publication: Dr Richard Russell

Dave Singh,1 Stefano Vezzoli,2 Stefano Petruzzelli,2 Alberto Papi3

1Medicines Evaluation Unit, University of Manchester, Manchester, UK; 2Chiesi Farmaceutici SpA, Parma, 3Section of Respiratory Diseases, University of Ferrara, Ferrara, Italy

Abstract: The GOLD 2017 strategy document recommends that the pharmacological management of COPD patients be based on the risk of future exacerbations and the severity of symptoms. A threshold of two moderate exacerbations or one hospitalization is used to define high-risk patients. The FORWARD study was a randomized, double-blind, parallel-group trial that compared 48 weeks’ treatment with extrafine beclomethasone dipropionate plus formoterol fumarate (BDP-FF) versus FF in severe COPD patients with a history of one or more exacerbations in the previous year. The new GOLD 2017 recommendations mean that many patients in the FORWARD study are now reclassified as GOLD B. We conducted a post hoc analysis of the FORWARD study, in order to investigate the effects of extrafine BDP/FF in patients with one exacerbation in the previous year, focusing on those categorized as group B using the GOLD 2017 definition. The analysis showed a 35% reduction in exacerbation rate with an inhaled corticosteroid (ICS) + long-acting β-agonist (LABA) versus LABA. We propose that ICS-LABA treatment is a therapeutic option for COPD patients with one exacerbation in the previous year.

Keywords: COPD, GOLD B, GOLD 2017, exacerbations, corticosteroid

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