A trial of beclomethasone/formoterol in COPD using EXACT-PRO to measure exacerbations

Dave Singh, Jorg Kampschulte, Jadwiga A. Wedzicha, Paul W. Jones, Géraldine Cohuet, Massimo Corradi, Tim Higenbottam, Stefano Petruzzelli, Jrøgen Vestbo

    Research output: Contribution to journalArticlepeer-review


    Combination inhalers containing corticosteroids and long-acting b-agonists are used to reduce exacerbation rates in patients with severe chronic obstructive pulmonary disease (COPD). The FORWARD (Foster 48-week Trial to Reduce Exacerbations in COPD) clinical trial in severe COPD patients is a comparison of extrafine beclomethasone dipropionate and formoterol in a combination inhaler with extrafine formoterol; the co-primary end-points are exacerbation rates over 48 weeks and improvement in forced expiratory volume in 1 s over 12 weeks. The traditional physician diagnosis of exacerbations is a co-primary outcome, and the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) means of collecting patient-reported outcome data are also being used to enhance the detection of exacerbation events. EXACT data are being collected using a novel application of a digital platform technology. FORWARD is therefore expected to provide information on the ability of EXACT to detect and measure exacerbations in a large clinical trial setting. The study design of FORWARD is described in this article. Copyright©ERS 2013.
    Original languageEnglish
    Pages (from-to)12-17
    Number of pages5
    JournalEuropean Respiratory Journal
    Issue number1
    Publication statusPublished - 1 Jan 2013


    • Chronic obstructive pulmonary disease
    • Corticosteroids


    Dive into the research topics of 'A trial of beclomethasone/formoterol in COPD using EXACT-PRO to measure exacerbations'. Together they form a unique fingerprint.

    Cite this