Bakerly Nawar Diar, Woodcock Ashley, New John P, Gibson J Martin, Wu Wei, Leather David, Vestbo Jørgen
Salford Royal NHS Foundation Trust, Salford, UK.
Institute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.
Respir Res. 2015 Sep 4;16(1):101. doi: 10.1186/s12931-015-0267-6.
New treatments need to be evaluated in real-world clinical practice to account for co-morbidities, adherence and polypharmacy.
Patients with chronic obstructive pulmonary disease (COPD), ≥ 40 years old, with exacerbation in the previous 3 years are randomised 1:1 to once-daily fluticasone furoate 100 μg/vilanterol 25 μg in a novel dry-powder inhaler versus continuing their existing therapy. The primary endpoint is the mean annual rate of COPD exacerbations; an electronic medical record allows real-time collection and monitoring of endpoint and safety data.
The Salford Lung Study is the world's first pragmatic randomised controlled trial of a pre-licensed medication in COPD.
Clinicaltrials.gov identifier NCT01551758.
新的治疗方法需要在真实世界的临床实践中进行评估，以考虑合并症、依从性和联合用药情况。
年龄≥40岁、在过去3年中有过病情加重的慢性阻塞性肺疾病（COPD）患者，以1:1的比例随机分配，一组使用新型干粉吸入器每日一次吸入100μg糠酸氟替卡松/25μg维兰特罗，另一组继续其现有治疗。主要终点是COPD病情加重的年均发生率；电子病历可实时收集和监测终点及安全性数据。
索尔福德肺部研究是世界上首个针对COPD中一种未获许可药物的实用性随机对照试验。
Clinicaltrials.gov标识符NCT01551758。
