University of Manchester, Medicines Evaluation Unit, University Hospital of South Manchester Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
Eur Respir J. 2013 Jan;41(1):12-7. doi: 10.1183/09031936.00207611. Epub 2012 May 31.
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.
含有皮质类固醇和长效β-激动剂的联合吸入器用于降低重度慢性阻塞性肺疾病（COPD）患者的恶化率。在严重 COPD 患者中进行的 FORWARD（减少 COPD 恶化的福斯特 48 周试验）临床试验是比较细布地奈德丙酸酯和福莫特罗在联合吸入器中的效果，主要终点是 48 周内的恶化率和 12 周内 1 秒用力呼气量的改善。传统的医生诊断恶化是主要结果之一，收集患者报告结果数据的慢性肺部疾病恶化工具（EXACT）也在被用于增强恶化事件的检测。EXACT 数据正在使用数字平台技术的新应用程序进行收集。因此，预计 FORWARD 将提供关于 EXACT 在大型临床试验环境中检测和衡量恶化的能力的信息。本文描述了 FORWARD 的研究设计。
