PT  - JOURNAL ARTICLE
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
TI  - A trial of beclomethasone/formoterol in COPD using EXACT-PRO to measure exacerbations
AID  - 10.1183/09031936.00207611
DP  - 2013 Jan 01
TA  - European Respiratory Journal
PG  - 12--17
VI  - 41
IP  - 1
4099  - http://erj.ersjournals.com/content/41/1/12.short
4100  - http://erj.ersjournals.com/content/41/1/12.full
SO  - Eur Respir J2013 Jan 01; 41
AB  - 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.