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: Article (Published version)
Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)
You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use. You may not use the material for commercial purposes.
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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: Article (Published version)
Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)
You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use. You may not use the material for commercial purposes. Exportado de SIDERAL (2025-01-08-09:01:57)
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Record created 2025-01-08, last modified 2025-01-08