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

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

Supplementary materials

Table S1 IECs/IRBs for recruitment wave 1

Table S2 IECs/IRBs for recruitment wave 2

Table S3 IECs/IRBs for recruitment wave 3

Acknowledgments

We acknowledge Elisa Veratelli (University of Ferrara, Ferrara, Italy) for scientific editorial assistance in the preparation of the manuscript. This study received funding support from Chiesi Farmaceutici, Parma, Italy.

Disclosure

DS reports personal fees from Apellis, Cipla, and Peptinnovate; and grants and personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Glenmark, Merck, Mundipharma, Novartis, Pfizer, Pulmatrix, Teva, Theravance, Verona, Genentech, and Skyepharma. SP and SV are employees of Chiesi Farmaceutici. AP reports grants and/or personal fees from Chiesi, AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, Merck Sharp and Menarini, Novartis, Zambon, Pfizer, Dohme, Takeda, Mundipharma, Teva, and Sanofi.