Journal Information
Vol. 60. Issue 7.
Pages 417-422 (July 2024)
Share
Share
Download PDF
More article options
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
Visits
4325
Alvar Agustia,
Corresponding author
aagusti@clinic.cat

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
Ver más
This item has received
Article information
Abstract
Full Text
Bibliography
Download PDF
Statistics
Figures (3)
Show moreShow less
Tables (1)
Table 1. Trial Population of the B+ Study.
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 (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.

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.

Keywords:
Chronic bronchitis
Emphysema
Exacerbations
GOLD groups
Tobacco smoking
Inhaled steroids

Article

These are the options to access the full texts of the publication Archivos de Bronconeumología
Member
If you are a member of SEPAR:
  • Go to >>>SEPAR<<< website and sign in.
Subscriber
Subscriber

If you already have your login data, please click here .

If you have forgotten your password you can you can recover it by clicking here and selecting the option “I have forgotten my password”
Subscribe
Subscribe to

Archivos de Bronconeumología

Purchase
Purchase article

Purchasing article the PDF version will be downloaded

Price 19.34 €

Purchase now
Contact
Phone for subscriptions and reporting of errors
From Monday to Friday from 9 a.m. to 6 p.m. (GMT + 1) except for the months of July and August which will be from 9 a.m. to 3 p.m.
Calls from Spain
932 415 960
Calls from outside Spain
+34 932 415 960
Email
Archivos de Bronconeumología
Article options
Tools

Are you a health professional able to prescribe or dispense drugs?