Preventing clinically important deterioration with single-inhaler triple therapy in COPD.

ABSTRACT: Clinically important deterioration (CID) is a novel composite end-point (lung function, health status, exacerbations) for assessing disease stability in patients with chronic obstructive pulmonary disease (COPD). We prospectively analysed CID in the FULFIL study. FULFIL (ClinicalTrials.gov NCT02345161; randomised, double-blind, double-dummy, multicentre study) compared 24?weeks of once daily, single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25?µg with twice daily budesonide/formoterol (BUD/FOR) 400/12??g in patients aged ?40 years with symptomatic advanced COPD (Global Initiative for Chronic Obstructive Lung Disease group D). A subset of patients received study treatment for up to 52?weeks. Time to first CID event was assessed over 24 and 52?weeks using two approaches for the health status component: St George's Respiratory Questionnaire and COPD assessment test. FF/UMEC/VI significantly reduced the risk of a first CID event by 47-52% versus BUD/FOR in the 24- and 52-week populations using both CID definitions (p<0.001). The median time to first CID event was ?169?days and ?31?days with FF/UMEC/VI and BUD/FOR, respectively. Only stable patients with no CID at 24?weeks demonstrated sustained clinically important improvements in lung function and health status at 52?weeks versus those who had experienced CID. Once daily, single-inhaler FF/UMEC/VI significantly reduced the risk of CID versus twice daily BUD/FOR with a five-fold longer period without deterioration.

SUBMITTER: Naya I 

PROVIDER: S-EPMC6168763 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature