• Dave Singh, Jorg Kampschulte, Jadwiga A Wedzicha, Paul W Jones, Géraldine Cohuet, Massimo Corradi, Tim Higenbottam, Stefano Petruzzelli, and Jørgen Vestbo.
• University of Manchester, Medicines Evaluation Unit, University Hospital of South Manchester Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK. dsingh@meu.org.uk
• Eur. Respir. J. 2013 Jan 1;41(1):12-7.

AbstractCombination 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.

14 keywords...

hide…