Triple Therapy and Clinical Control in B+ COPD Patients: A Pragmatic, Prospective, Randomized Trial
Year: 2024
Type: article
Abstract: 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.
Source: Archivos de Bronconeumología
Authors: Alvar Agusti, José Luis Lopez-Campos, Marc Miravitlles, Juan Jose Soler-Cataluña, Jose Maria Marin, Borja G. Cosio, Bernardino Alcázar-Navarrete, Jose Maria Echave-Sustaeta, Ciro Casanova, German Peces-Barba, Juan Pablo de-Torres, Alberto Fernandez-Villar, Julio Ancochea, Felipe Villar-Alvarez, Miguel Roman-Rodriguez, Jesus Molina, Juan Luis Garcia-Rivero, Cruz Gonzalez, Patricia Sobradillo, Rosa Faner, Carolina Peña, Raj Sharma, José Luis Izquierdo, Bartolome R. Celli
Institutions: Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Fundació Clínic per a la Recerca Biomèdica, Consorci Institut D'Investigacions Biomediques August Pi I Sunyer, Universitat de Barcelona, Instituto de Salud Carlos III, Instituto de Biomedicina de Sevilla, Hospital Universitario Virgen del Rocío, Universidad de Sevilla, Vall d'Hebron Institut de Recerca, Vall d'Hebron Hospital Universitari, Universitat de València, Hospital Arnau de Vilanova, Hospital Universitario Miguel Servet, Instituto de Investigación Sanitaria Aragón, Health Research Institute of the Balearic Islands, Hospital Universitario Son Espases, Universitat de les Illes Balears, Universidad de Granada, Instituto de Investigación Biosanitaria de Granada, Hospital Universitario Virgen de las Nieves, Hospital Universitario Quirónsalud Madrid, Universidad Europea de Madrid, Universidad de La Laguna, Hospital Universitario Nuestra Señora de Candelaria, Instituto de Investigación Sanitaria Fundación Jiménez Díaz, Navarre Institute of Health Research, Clinica Universidad de Navarra, Hospital Universitario de La Princesa, Universidad Autónoma de Madrid, Marqués de Valdecilla University Hospital, Hospital Clínico Universitario de Valencia, Hospital de Cruces, GlaxoSmithKline (Spain), GlaxoSmithKline (United Kingdom), GlaxoSmithKline Research & Development Limited (United Kingdom), Universidad de Alcalá, Hospital Universitario de Guadalajara, Harvard University
Language: Spanish
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,290
OpenAlex ID: W4395450466