Extrafine beclomethasone/formoterol in severe COPD patients with history of exacerbations

J. A. Wedzicha, D. Singh, J. Vestbo, P. L. Paggiaro, P. W. Jones, F. Bonnet-Gonod, G. Cohuet, M. Corradi, S. Vezzoli, S. Petruzzelli, A. Agusti

    Research output: Contribution to journalArticlepeer-review


    The FORWARD study is a randomised, double-blind trial that compares the efficacy and safety of 48 weeks treatment with extrafine beclomethasone dipropionate/formoterol fumarate (BDP/FOR), 100/6 μg pMDI, 2 inhalations BID, vs. FOR 12 μg pMDI, 1 inhalation BID, in severe COPD patients with a history of exacerbations. Co-primary endpoints were exacerbation rate over 48 weeks and pre-dose morning FEV1 at 12 weeks. The ITT population included 1186 patients (69% males, mean age 64 years) with severe airflow limitation (mean post-bronchodilator FEV1 42% predicted). Salbutamol as rescue therapy, theophylline and tiotropium (if stable regimen prior to screening) were allowed. Compared to FOR, BDP/FOR: (1) reduced the exacerbation rate (rate ratio: 0.72 [95% confidence interval 0.62-0.84], p <0.001); (2) improved pre-dose morning FEV1 (mean difference: 0.069 L [0.043-0.095] p <0.001); (3) prolonged the time to first exacerbation; (4) improved the SGRQ total score. The percentage of patients with adverse events was similar (52.1% with BDP/FOR and 49.2% with FOR). Pneumonia incidence was low, slightly higher with BDP/FOR (3.8%) than with FOR (1.8%). No difference for laboratory values, ECG or vital signs. Extrafine BDP/FOR significantly reduces the exacerbation rate and improves lung function of patients with severe COPD and history of exacerbations as compared to FOR alone. © 2014 The Authors. Published by Elsevier Ltd.
    Original languageEnglish
    Pages (from-to)1153-1162
    Number of pages9
    JournalRespiratory Medicine
    Issue number8
    Publication statusPublished - 2014


    • COPD
    • Exacerbation
    • Extrafine
    • Inhaled steroids
    • Long acting bronchodilators
    • Patient reported outcomes


    Dive into the research topics of 'Extrafine beclomethasone/formoterol in severe COPD patients with history of exacerbations'. Together they form a unique fingerprint.

    Cite this