Triple Therapy and Clinical Control in B+ COPD Patients: A Pragmatic, Prospective, Randomized Trial

• Alvar Agusti ^[11] ; José Luis Lopez Campos ^[12] ; Marc Miravitlles ^[13] ; Juan Jose Soler Cataluña ^[1] ; Jose Maria Marin ^[2] ; Borja G. Cosio ^[14] ; Bernardino Alcázar Navarrete ^[3] ; Jose Maria Echave Sustaeta ^[4] ; Ciro Casanova ^[15] ; German Peces Barba ^[5] ; Juan Pablo de Torres ^[6] ; Alberto Fernandez Villar ^[6] ; Julio Ancochea ^[1] ; Felipe Villar Alvarez ^[16] ; Miguel Roman Rodriguez ^[17] ; Jesus Molina ^[18] ; Juan Luis Garcia Rivero ^[7] ; Cruz Gonzalez ^[19] ; Patricia Sobradillo ^[20] ; Rosa Faner ^[8] ; Carolina Peña ^[21] ; Raj Sharma ^[22] ; José Luis Izquierdo ^[9] ; Bartolome R. Celli ^[10]
  1. [1] Centro de Investigacion Biomedica en Red de Enfermedades Respiratorias

     Centro de Investigacion Biomedica en Red de Enfermedades Respiratorias

     Madrid, España

     
  2. [2] Hospital Miguel Servet

     Hospital Miguel Servet

     Zaragoza, España

     
  3. [3] Hospital Universitario Virgen de las Nieves

     Hospital Universitario Virgen de las Nieves

     Granada, España

     
  4. [4] Universidad Europea de Madrid

     Universidad Europea de Madrid

     Madrid, España

     
  5. [5] Fundación Jiménez Díaz

     Fundación Jiménez Díaz

     Madrid, España

     
  6. [6] Universidad de Navarra

     Universidad de Navarra

     Pamplona, España

     
  7. [7] Hospital Universitario Marqués de Valdecilla

     Hospital Universitario Marqués de Valdecilla

     Santander, España

     
  8. [8] Universitat de Barcelona

     Universitat de Barcelona

     Barcelona, España

     
  9. [9] Hospital Universitario de Guadalajara

     Hospital Universitario de Guadalajara

     Guadalajara, España

     
  10. [10] Harvard Medical School

      Harvard Medical School

      City of Boston, Estados Unidos

      
  11. [11] Cátedra Salud Respiratoria, Universidad Barcelona, Institut Respiratori, Clinic Barcelona, FCRB-IDIBAPS, CIBERES, Spain
  12. [12] Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío/Universidad de Sevilla, Spain
  13. [13] Pneumology Department, Hospital Universitari Vall d’Hebron/Vall d’Hebron Institut de Recerca (VHIR), Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain
  14. [14] Department of Respiratory Medicine, Hospital Universitario Son Espases-IdISBa, Universidad de las Islas Baleares, CIBERES, Spain
  15. [15] Pulmonary Department – Research Unit, Hospital Universitario Nuestra Señora de La Candelaria, CIBERES, ISCIII, Universidad de La Laguna, Santa Cruz de Tenerife, Spain
  16. [16] Pulmonology Department, IIS Fundación Jiménez Díaz, Universidad Autónoma of Madrid, CIBER Enfermedades Respiratorias, Madrid, Spain
  17. [17] Primary Care Health Service Mallorca, Instituto de Investigación Sanitaria de las Islas Baleares (IdISBa) Palma, Universidad de las Islas Baleares, Spain
  18. [18] Centro de Salud Francia, Fuenlabrada, Madrid, Spain
  19. [19] Respiratory Department, Hospital Clínico Universitario, Valencia, Spain
  20. [20] Pulmonology Department, Hospital Universitario de Cruces, Barakaldo, Vizcaya, Spain
  21. [21] GSK, Madrid, Spain
  22. [22] GSK, London, UK

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• Localización: Archivos de bronconeumología: Organo oficial de la Sociedad Española de Neumología y Cirugía Torácica SEPAR y la Asociación Latinoamericana de Tórax ( ALAT ), ISSN 0300-2896, Vol. 60, Nº. 7, 2024, págs. 417-422
• Idioma: inglés
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• Resumen

  • 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.