INTREPID: single- versus multiple-inhaler triple therapy for COPD in usual clinical practice

Abstract

IntroductionReal-world trial data comparing single- with multiple-inhaler triple therapy (MITT) in COPD patients are currently lacking. The effectiveness of once-daily single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) and MITT were compared in usual clinical care.MethodsINTREPID was a multicentre, randomised, open-label, phase IV effectiveness study comparing FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA inhaler with a clinician's choice of any approved non-ELLIPTA MITT in usual COPD clinical practice in five European countries. Primary endpoint was proportion of COPD Assessment Test (CAT) responders (≥2-unit decrease in CAT score from baseline) at Week 24. Secondary endpoints in a subpopulation included change from baseline in forced expiratory volume in 1 s (FEV1) and percentage of patients making ≥1 critical error in inhalation technique at Week 24. Safety was also assessed.Results3092 patients were included (FF/UMEC/VI N=1545; MITT N=1547). The proportion of CAT responders at Week 24 was significantly greater with FF/UMEC/VI versus non-ELLIPTA MITT (odds ratio: 1.31; 95% confidence interval [CI]: 1.13, 1.51; p<0.001) and mean change from baseline in FEV1 was significantly greater with FF/UMEC/VI (77 mL versus 28 mL; treatment difference [95% CI] 50 mL [26, 73]; p<0.001). The percentage of patients with ≥1 critical error in inhalation technique was low in both groups (FF/UMEC/VI 6%, non-ELLIPTA MITT 3%). Safety profiles, including incidence of pneumonia serious adverse events, were similar between treatments.ConclusionsIn a usual clinical care setting, treatment with once-daily single-inhaler FF/UMEC/VI resulted in significantly more patients gaining health status improvement and greater lung function improvement versus non-ELLIPTA MITT.