TRIPLE THERAPY AND CLINICAL CONTROL IN B+ COPD PATIENTS: A PRAGMATIC, PROSPECTIVE, RANDOMIZED TRIAL
"Triple Therapy and Clinical Control in B+ COPD Patients" Background: 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 COPD patients (here termed GOLD B+ patients)characterized by:
1. Remaining symptomatic (CAT≥10) despite regular LABA/LAMA therapy;
2. Having suffered 1moderate exacerbation the previous year;
3. Having blood eosinophil counts (BEC) ≥150 cells/μL.
"Triple Therapy and Clinical Control in B+ COPD Patients" 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;
2. Use a composite index (CC) as the primary result of a COPD trial.
Authors
A Agusti (Dr), JL Lopez-Campos, M Miravitlles, JJ Soler-Cataluña, JM Marin, BG Cosio, B Alcázar Navarrete, JM Echave-Sustaeta, C Casanova, G Peces Barba, JP de-Torres, A Fernandez Villar, J Ancochea, F Villar Alvarez, M Roman Rodriguez, J Molina, JL Garcia-Rivero, C Gonzalez, P Sobradillo, R Faner, C Peña, R Sharma, B Celli.
Read more details at
Noticias relacionadas
Riesgo CV en el Paciente con EPOC: una visión multidisciplinar
Participa en «Riesgo Cardiovascular en el Paciente con EPOC» de la Universidad de Barcelona. Modalidad presencial y online. ¡Inscríbete ahora!
Iniciativa ‘Sense Límits’ de SOCAP y Chiesi: Concienciación y Apoyo a Enfermedades Respiratorias como EPOC y Asma
La Societat Catalana de Pneumologia (SOCAP) y Chiesi han lanzado la iniciativa ‘Sense Límits’ para concienciar sobre las enfermedades respiratorias, con actividades divulgativas y solidarias como espirometrías, pedaleos solidarios y marchas nórdicas, promoviendo la investigación científica y el cuidado de la salud respiratoria.
Relationship between Respiratory Microbiome and Systemic Inflammatory Markers in COPD: A Pilot Study
This study explores how changes in the respiratory microbiome relate to systemic inflammation in COPD patients. It highlights correlations between bacterial abundance, eosinophilic markers, and airflow limitation severity.
Artículos
COPD
- 759578·Alberto Papi et Al.-Relationships between symptoms and lung function in asthma and/or chronic obstructive pulmonary disease in a real-life setting: the NOVEL observational longiTudinal studY
- 759785·Richard Beasley et Al – Prevalence, Diagnostic Utility and Associated Characteristics of Bronchodilator Responsiveness
- 759788·Alvar Agustí, Rod Hughes, Eleni Rapsomaki, Barry Make, Ricardo Del Olmo, Alberto Papi, David Price, Laura Benton, Stefan Franzen, Jørgen Vestbo, Hana Mullerova – The many faces of COPD in real life: a longitudinal analysis of the NOVELTY cohort
- 759883·Alberto Papi, Rosa Faner, Ian Pavord, Federico Baraldi, Vanessa M McDonald, Mike Thomas, Marc Miravitlles, Nicholas Roche, Alvar Agustí. – From treatable traits to GETomics in airway disease: moving towards clinical practice
- 768799·Surya P Bhatt Richard Casaburi Alvar Agusti et Al. Chronic obstructive pulmonary disease: hiding in plain sight, a Statement from the COPD Foundation Medical and Scientific Advisory Committee
Ensayos
- 769685·Nuria Olvera et Al.- Lung Tissue Multi-Layer Network Analysis Uncovers the Molecular Heterogeneity of COPD
- 779885·Ana Rodrigo-T,Jordi Giner,Lidia Perea,Jose Luis Merino,Núria Albacar,Belén Solarat,Diego Castillo,Rosa Faner,Alvar Agustí,Oriol Sibila. Predicting Early Hospital Readmissions in COPD Patients Using an Electronic Nose | Archivos de Bronconeumología
- 788772·Alvar Agustí et al. Add-on inhaled budesonide in the treatment of hospitalised patients with COVID-19: a randomised clinical trial
Imagen obtenida en Canva Pro.
