A TRIAL OF BECLOMETHASONE/FORMOTEROL IN COPD USINGEXACT-PRO TO MEASURE EXACERBATIONS

Combination inhalers containing corticosteroids and long acting beta agonists are used to reduce exacerbation rates in patients with severe 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 (BDP/F) in a combination inhaler with extrafine F ; the co-primary endpoints are exacerbation rates over 48 weeks and improvement in FEV1 over 12 weeks. The traditional physician diagnosis of exacerbations is a co-primary outcome, and the EXACT means of collecting patient-reported outcome (PRO) data is also being used to enhance the detection of exacerbation events. EXACT data is 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 paper.