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

Halpin, David M.G. ; Worsley, Sally ; Ismaila, Afisi S. ; Beeh, Kai-Michael ; Midwinter, Dawn ; Kocks, Janwillem W.H. ; Irving, Elaine ; Marin, José M. (Universidad de Zaragoza) ; Martin, Neil ; Tabberer, Maggie ; Snowise, Neil G. ; Compton, Chris

Resumen: 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 (FF)/umeclidinium (UMEC)/vilanterol (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 µgviathe ELLIPTA inhaler with a clinician's choice of any approved non-ELLIPTA MITT in usual COPD clinical practice in five European countries. Primary end-point was proportion of COPD Assessment Test (CAT) responders (≥2-unit decrease in CAT score from baseline) at week 24. Secondary end-points in a subpopulation included change from baseline in forced expiratory volume in 1 s (FEV1) and percentage of patients making at least one 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/VIversusnon-ELLIPTA MITT (OR 1.31, 95% CI 1.13–1.51; p<0.001) and mean change from baseline in FEV1was significantly greater with FF/UMEC/VI (77 mLversus28 mL; treatment difference 50 mL, 95% CI 26–73 mL; p<0.001). The percentage of patients with at least one 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 improvementversusnon-ELLIPTA MITT.

Idioma: Inglés

DOI: 10.1183/23120541.00950-2020

Año: 2021

Publicado en: ERJ Open Research 7, 2 (2021), 00950-2020
ISSN: 2312-0541

Factor impacto JCR: 4.239 (2021)

Categ. JCR: RESPIRATORY SYSTEM rank: 29 / 66 = 0.439 (2021) - Q2 - T2

Factor impacto CITESCORE: 4.6 - Medicine (Q2)

Factor impacto SCIMAGO: 0.944 - Pulmonary and Respiratory Medicine (Q2)

Tipo y forma: Artículo (Versión definitiva)

Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)