Clinically important deterioration in advanced COPD patients using single inhaler triple therapy: results from the FULFIL study

Abstract

A prospective analysis of clinically important deterioration (CID), a composite measure (lung function, health status and exacerbations) of worsening COPD (Singh, et al. Int J COPD 2016; 11:1413), in the FULFIL study is reported. FULFIL assessed once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100μg/62.5μg/25μg via a single ELLIPTA ® inhaler vs. twice-daily budesonide/formoterol (BUD/FOR) 400μg/12μg via the Turbuhaler ® in patients with advanced COPD (Lomas, et al. ERJ 2016;48:PA4629). CID was assessed for 24 weeks (intent-to-treat population; ITT) and 52 weeks (extension study; EXT) and defined as: D1, deterioration from baseline of ≥100mL in FEV1 or ≥4 units in St Georges Respiratory Questionnaire (SGRQ) score or a moderate-severe exacerbation; D2, replaced SGRQ with a >2 unit deterioration in COPD assessment test (CAT) score. Risk reduction was derived from time to first event analysis using a Cox proportional hazard model. In the ITT (N=1810) and EXT (n=430), FF/UMEC/VI significantly reduced the risk of a CID by 47–52% vs. BUD/FOR (p In this prospective analysis, FF/UMEC/VI reduced the risk of CIDs vs. BUD/FOR, and CAT and SGRQ provided comparable results.