Woodcock Ashley, Bakerly Nawar Diar, New John P, Gibson J Martin, Wu Wei, Vestbo Jørgen, Leather David
Institute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.
Salford Royal NHS Foundation Trust, Salford, UK.
BMC Pulm Med. 2015 Dec 10;15:160. doi: 10.1186/s12890-015-0150-8.
Novel therapies need to be evaluated in normal clinical practice to allow a true representation of the treatment effectiveness in real-world settings.
METHODS/DESIGN: The Salford Lung Study is a pragmatic randomised controlled trial in adult asthma, evaluating the clinical effectiveness and safety of once-daily fluticasone furoate (100 μg or 200 μg)/vilanterol 25 μg in a novel dry-powder inhaler, versus existing asthma maintenance therapy. The study was initiated before this investigational treatment was licensed and conducted in real-world clinical practice to consider adherence, co-morbidities, polypharmacy, and real-world factors.
Asthma Control Test at week 24; safety endpoints include the incidence of serious pneumonias. The study utilises the Salford electronic medical record, which allows near to real-time collection and monitoring of safety data.
The Salford Lung Study is the world's first pragmatic randomised controlled trial of a pre-licensed medication in asthma. Use of patients' linked electronic health records to collect clinical endpoints offers minimal disruption to patients and investigators, and also ensures patient safety. This highly innovative study will complement standard double-blind randomised controlled trials in order to improve our understanding of the risk/benefit profile of fluticasone furoate/vilanterol in patients with asthma in real-world settings.
Clinicaltrials.gov, NCT01706198; 04 October 2012.
新型疗法需要在正常临床实践中进行评估，以便真实反映其在现实环境中的治疗效果。
方法/设计：索尔福德肺部研究是一项针对成人哮喘的实用随机对照试验，旨在评估新型干粉吸入器中每日一次的糠酸氟替卡松（100μg或200μg）/维兰特罗25μg与现有哮喘维持疗法相比的临床有效性和安全性。该研究在这种研究性治疗获得许可之前启动，并在现实临床实践中进行，以考虑依从性、合并症、联合用药和现实因素。
第24周时的哮喘控制测试；安全终点包括严重肺炎的发生率。该研究利用索尔福德电子病历，可实现近乎实时的安全数据收集和监测。
索尔福德肺部研究是世界上首个针对哮喘患者使用未获许可药物的实用随机对照试验。利用患者关联的电子健康记录收集临床终点数据对患者和研究人员的干扰最小，同时也确保了患者安全。这项极具创新性的研究将补充标准双盲随机对照试验，以增进我们对糠酸氟替卡松/维兰特罗在现实环境中哮喘患者风险/获益情况的了解。
Clinicaltrials.gov，NCT01706198；2012年10月4日。
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