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Vol. 60. Issue 7.
Pages 417-422 (July 2024)
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Vol. 60. Issue 7.
Pages 417-422 (July 2024)
Original Article
Triple Therapy and Clinical Control in B+ COPD Patients: A Pragmatic, Prospective, Randomized Trial
Alvar Agustia,
Corresponding author

Corresponding author.
, José Luis Lopez-Camposb,c, Marc Miravitllesd, Juan Jose Soler-Cataluñac,e,f, Jose Maria Maring, Borja G. Cosioh, Bernardino Alcázar-Navarretei, Jose Maria Echave-Sustaetaj, Ciro Casanovak, German Peces-Barbal, Juan Pablo de-Torresm, Alberto Fernandez-Villarc,n, Julio Ancocheao, Felipe Villar-Alvarezp, Miguel Roman-Rodriguezq, Jesus Molinar,s, Juan Luis Garcia-Riverot, Cruz Gonzalezu, Patricia Sobradillov, Rosa Fanerw..., Carolina Peñax, Raj Sharmay, José Luis Izquierdoz, Bartolome R. CelliaaVer más
a Cátedra Salud Respiratoria, Universidad Barcelona, Institut Respiratori, Clinic Barcelona, FCRB-IDIBAPS, CIBERES, Spain
b Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío/Universidad de Sevilla, Spain
c Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain
d Pneumology Department, Hospital Universitari Vall d’Hebron/Vall d’Hebron Institut de Recerca (VHIR), Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain
e Servicio de Neumología, Hospital Arnau de Vilanova-Lliria, Valencia, Spain
f Departamento de Medicina, Universitat de València, Spain
g Respiratory Service, Hospital Universitario Miguel Servet, IISAragón, Zaragoza, Spain
h Department of Respiratory Medicine, Hospital Universitario Son Espases-IdISBa, Universidad de las Islas Baleares, CIBERES, Spain
i Servicio de Neumología, Hospital Universitario Virgen de las Nieves, IBS-Granada, Universidad de Granada, CIBERES, Spain
j Pulmonary Department, Hospital Universitario Quironsalud Madrid, Universidad Europea de Madrid, Spain
k Pulmonary Department – Research Unit, Hospital Universitario Nuestra Señora de La Candelaria, CIBERES, ISCIII, Universidad de La Laguna, Santa Cruz de Tenerife, Spain
l Pulmonology Department, IIS Fundación Jiménez Díaz, CIBERES, Spain
m Pulmonary Department, Clinica Universidad de Navarra, IdisNa, Spain
n Servicio de Neumología, Hospital Álvaro Cunqueiro, Instituto de Investigación Sanitaria Galicia Sur, Vigo, Spain
o Hospital Universitario de La Princesa, Universidad Autónoma de Madrid, CIBER Enfermedades Respiratorias, Madrid, Spain
p Pulmonology Department, IIS Fundación Jiménez Díaz, Universidad Autónoma of Madrid, CIBER Enfermedades Respiratorias, Madrid, Spain
q Primary Care Health Service Mallorca, Instituto de Investigación Sanitaria de las Islas Baleares (IdISBa) Palma, Universidad de las Islas Baleares, Spain
r Centro de Salud Francia, Fuenlabrada, Madrid, Spain
s Dirección Asistencial Oeste, Spain
t Respiratory Department, Hospital Universitario Marqués de Valdecilla, Santander, Spain
u Respiratory Department, Hospital Clínico Universitario, Valencia, Spain
v Pulmonology Department, Hospital Universitario de Cruces, Barakaldo, Vizcaya, Spain
w Biomedicine Department, University of Barcelona, FCRB-IDIBAPS, CIBERES, Barcelona, Spain
x GSK, Madrid, Spain
y GSK, London, UK
z Department of Medicine and Medical Specialties, Universidad de Alcalá, Alcalá de Henares, Madrid, Respiratory Medicine, Hospital Universitario de Guadalajara, Guadalajara, Spain
aa Harvard Medical School, Boston, USA
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Table 1. Trial Population of the B+ Study.

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 (CAT10) despite regular LABA/LAMA therapy; (2) having suffered one moderate exacerbation in the previous year; and (3) having blood eosinophil counts (BEC) ≥150cells/μL.


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.


The first patient was recruited on February 29, 2024; results are expected in the first quarter of 2026.


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.

Chronic bronchitis
GOLD groups
Tobacco smoking
Inhaled steroids


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