Resumen de Triple Therapy and Clinical Control in B+ COPD Patients: A Pragmatic, Prospective, Randomized Trial
Àlvar Agustí García-Navarro, José Luis López-Campos Bodineau, Marc Miravitlles, Juan José Soler Cataluña, J. M. Marín Trigo, B. G. Cosío, Bernardino Alcázar Navarrete, J. Mª Echave-Sustaeta, Ciro Casanova Macario, Germán Peces Barba, Juan Pablo de Torres Tajes, Alberto Fernandez Villar, Julio Ancochea Bermúdez, Felipe Villar Álvarez, Miguel Roman Rodriguez, Jesús Molina París, Juan Luis García Rivero, C. González Villaescusa, Patricia Sobradillo, Maria Rosa Faner Canet, Carolina Peña, Raj Sharma, José Luis Izquierdo Alonso, Bartolomé R. Celli
Introduction 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.
