TY - JOUR T1 - A trial of beclomethasone/formoterol in COPD using EXACT-PRO to measure exacerbations JF - European Respiratory Journal JO - Eur Respir J SP - 12 LP - 17 DO - 10.1183/09031936.00207611 VL - 41 IS - 1 AU - Dave Singh AU - Jorg Kampschulte AU - Jadwiga A. Wedzicha AU - Paul W. Jones AU - Géraldine Cohuet AU - Massimo Corradi AU - Tim Higenbottam AU - Stefano Petruzzelli AU - Jørgen Vestbo Y1 - 2013/01/01 UR - http://erj.ersjournals.com/content/41/1/12.abstract N2 - Combination inhalers containing corticosteroids and long-acting β-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. ER -