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

作者：Singh Dave^*; Kampschulte Jorg; Wedzicha Jadwiga A; Jones Paul W; Cohuet Geraldine; Corradi Massimo; Higenbottam Tim; Petruzzelli Stefano; Vestbo Jorgen

来源：European Respiratory Journal, 2013, 41(1): 12-17.

DOI：10.1183/09031936.00207611

• Chronic obstructive pulmonary disease
• corticosteroids

Combination inhalers containing corticosteroids and long-acting beta-agonists are used to reduce exacerbation rates in patients with severe chronic obstructive pulmonary disease (COPD). %26lt;br%26gt;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. %26lt;br%26gt;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.

• 出版日期2013-1