LATE-BREAKING ABSTRACT: Effect of fluticasone furoate (FF)/vilanterol (VI) on the rate of COPD exacerbations in everyday clinical practice: Results of the COPD Salford lung study (SLS)

SLS is an open label RCT that aims to guide COPD treatment by generating effectiveness and safety data in a population intended to represent that seen in everyday clinical practice (Bakerly et al. Respir Res 2015;16:101). COPD patients >40 years with ≥1 exacerbation in the previous 3 years were randomized 1:1 to initiate treatment with FF/VI 100/25mcg OD or continue on usual maintenance therapy (UC) for 12 months. Safety monitoring was performed by telephone every 3 months (unless other contact); other data were collected in real-time using an integrated primary & secondary care electronic medical record to normalise the patient experience. Primary endpoint is annual rate of moderate/severe exacerbations. Based on 2799 ITT patients; baseline exacerbation rate was 2.01; pre-bronchodilator FEV 1 % predicted was 56%. 177 patients experienced an SAE of pneumonia 94 initiated on FF/VI; 83 on UC (Incidence ratio 1.1, 95% CI 0.9–1.5). The SAE profile was similar across the groups. In an everyday clinical practice setting treatment initiated with FF/VI significantly reduced the rate of exacerbations compared with UC. FF/VI was non-inferior to UC for incidence of pneumonia. GSK Funded (HZC115151; NCT01551758).