000147886 001__ 147886
000147886 005__ 20250923084439.0
000147886 0247_ $$2doi$$a10.1016/j.arbres.2024.04.008
000147886 0248_ $$2sideral$$a141353
000147886 037__ $$aART-2024-141353
000147886 041__ $$aeng
000147886 100__ $$aAgusti, Alvar
000147886 245__ $$aTriple Therapy and Clinical Control in B+ COPD Patients: A Pragmatic, Prospective, Randomized Trial
000147886 260__ $$c2024
000147886 5060_ $$aAccess copy available to the general public$$fUnrestricted
000147886 5203_ $$aIntroduction: Treatment with LABA/LAMA is recommended in GOLD B patients. We hypothesized that triple therapy (LABA/LAMA/ICS) will be superior to LABA/LAMA in achieving and maintaining clinical control (CC), a composite outcome that considers both impact and disease stability in a subgroup of GOLD B patients (here termed GOLD B+ patients) characterized by: (1) remaining symptomatic (CAT≥10) despite regular LABA/LAMA therapy; (2) having suffered one moderate exacerbation in the previous year; and (3) having blood eosinophil counts (BEC) ≥150cells/μL.
Methods: The ANTES B+ study is a prospective, multicenter, open label, randomized, pragmatic, controlled trial designed to test this hypothesis. It will randomize 1028 B+ patients to continue with their usual LABA/LAMA combination prescribed by their attending physician or to begin fluticasone furoate (FF) 92μg/umeclidinium (UMEC) 55μg/vilanterol (VI) 22μg in a single inhaler q.d. for 12 months. The primary efficacy outcome will be the level of CC achieved. Secondary outcomes include the clinical important deterioration index (CID), annual rate of exacerbations, and FEV1. Exploratory objectives include the interaction of BEC and smoking status, all-cause mortality and proportion of patients on LABA/LAMA arm that switch therapy arms. Safety analysis include adverse events and incidence of pneumonia.
Results: The first patient was recruited on February 29, 2024; results are expected in the first quarter of 2026.
Conclusions: The ANTES B+ study is the first to: (1) explore the efficacy and safety of triple therapy in a population of B+ COPD patients and (2) use a composite index (CC) as the primary result of a COPD trial.
000147886 540__ $$9info:eu-repo/semantics/openAccess$$aby-nd$$uhttp://creativecommons.org/licenses/by-nd/3.0/es/
000147886 590__ $$a9.2$$b2024
000147886 592__ $$a0.466$$b2024
000147886 591__ $$aRESPIRATORY SYSTEM$$b6 / 108 = 0.056$$c2024$$dQ1$$eT1
000147886 593__ $$aPulmonary and Respiratory Medicine$$c2024$$dQ3
000147886 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion
000147886 700__ $$aLopez-Campos, José Luis
000147886 700__ $$aMiravitlles, Marc
000147886 700__ $$aSoler-Cataluña, Juan Jose
000147886 700__ $$0(orcid)0000-0001-9096-2294$$aMarin, Jose Maria$$uUniversidad de Zaragoza
000147886 700__ $$aCosio, Borja G.
000147886 700__ $$aAlcázar-Navarrete, Bernardino
000147886 700__ $$aEchave-Sustaeta, Jose Maria
000147886 700__ $$aCasanova, Ciro
000147886 700__ $$aPeces-Barba, German
000147886 700__ $$ade-Torres, Juan Pablo
000147886 700__ $$aFernandez-Villar, Alberto
000147886 700__ $$aAncochea, Julio
000147886 700__ $$aVillar-Alvarez, Felipe
000147886 700__ $$aRoman-Rodriguez, Miguel
000147886 700__ $$aMolina, Jesus
000147886 700__ $$aGarcia-Rivero, Juan Luis
000147886 700__ $$aGonzalez, Cruz
000147886 700__ $$aSobradillo, Patricia
000147886 700__ $$aFaner, Rosa
000147886 700__ $$aPeña, Carolina
000147886 700__ $$aSharma, Raj
000147886 700__ $$aIzquierdo, José Luis
000147886 700__ $$aCelli, Bartolome R.
000147886 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina
000147886 773__ $$g60, 7 (2024), 417-422$$pArch. bronconeumol.$$tArchivos de Bronconeumologia$$x0300-2896
000147886 8564_ $$s1125417$$uhttps://zaguan.unizar.es/record/147886/files/texto_completo.pdf$$yVersión publicada
000147886 8564_ $$s2622989$$uhttps://zaguan.unizar.es/record/147886/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada
000147886 909CO $$ooai:zaguan.unizar.es:147886$$particulos$$pdriver
000147886 951__ $$a2025-09-22-14:49:17
000147886 980__ $$aARTICLE