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THE ANTES B+ STUDY: AN OPEN-LABEL, PRAGMATIC, RANDOMIZED, CONTROLLED TRIAL OF TRIPLE THERAPY VERSUS LABA-LAMA COMBINATION TO IMPROVE CLINICAL CONTROL IN HIGH-RISK GOLD B PATIENTS (B+)

Key facts

Where
Barcelona, Burgos, Cáceres, Fuenlabrada, Galdakao, Granada, Guadalajara, L'hospitalet De Llobregat, Lleida, Madrid, Majadahonda, Málaga, Oviedo, Palma, Pamplona, Ponferrada, Pozuelo de Alarcón, Salamanca, Santa Cruz de Tenerife, Santander, Sevilla, Valencia, Valladolid, Vigo és Zaragoza, SpanyolországSee the 37 sites
Phase
4. fázis

Where in Spanyolország

  • Consorci D'atencio Primaria De Salut Barcelona EsquerraBarcelona, SpanyolországNo longer taking part
  • Hospital Clinic de BarcelonaBarcelona, SpanyolországNo longer taking part
  • Hospital Universitari Vall d'HebronBarcelona, SpanyolországNo longer taking part
  • Hospital Universitario De BurgosBurgos, SpanyolországNo longer taking part
  • Hospital San Pedro De AlcántaraCáceres, SpanyolországNo longer taking part
  • Centro de Salud FranciaFuenlabrada, SpanyolországNo longer taking part
  • Hospital de Galdakao-UsansoloGaldakao, SpanyolországNo longer taking part
  • Hospital Universitario Virgen de las NievesGranada, SpanyolországNo longer taking part
  • Hospital Universitario De Guadalajara SESCAMGuadalajara, SpanyolországNo longer taking part
  • Bellvitge University HospitalL'hospitalet De Llobregat, SpanyolországNo longer taking part
  • Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De LleidaLleida, SpanyolországNo longer taking part
  • Clinica Universidad de NavarraMadrid, SpanyolországNo longer taking part
  • Hospital Clínico San CarlosMadrid, SpanyolországNo longer taking part
  • Hospital Universitario de la PrincesaMadrid, SpanyolországNo longer taking part
  • Hospital Universitario Fundación Jiménez DíazMadrid, SpanyolországNo longer taking part
  • Hospital Universitario Infanta LeonorMadrid, SpanyolországNo longer taking part
  • Hospital Universitario La PazMadrid, SpanyolországNo longer taking part
  • Hospital Universitario Puerta de Hierro de MajadahondaMajadahonda, SpanyolországNo longer taking part
  • Hospital Universitario Regional de MálagaMálaga, SpanyolországNo longer taking part
  • Hospital Universitario Central De AsturiasOviedo, SpanyolországNo longer taking part
  • Servei De Salut De Les Illes BalearsPalma, SpanyolországNo longer taking part
  • University Hospital Son EspasesPalma, SpanyolországNo longer taking part
  • Clínica Universidad de navarraPamplona, SpanyolországNo longer taking part
  • Hospital Universitario de NavarraPamplona, SpanyolországNo longer taking part
  • Hospital El BierzoPonferrada, SpanyolországNo longer taking part
  • Hospital Universitario Quironsalud MadridPozuelo de Alarcón, SpanyolországNo longer taking part
  • Hospital Universitario De SalamancaSalamanca, SpanyolországNo longer taking part
  • Hospital Universitario Nuestra Señora de CandelariaSanta Cruz de Tenerife, SpanyolországNo longer taking part
  • Hospital Universitario Marqués de ValdecillaSantander, SpanyolországNo longer taking part
  • University Hospital Virgen Del Rocio S.L.Sevilla, SpanyolországNo longer taking part
  • Hospital Arnau de Vilanova de ValenciaValencia, SpanyolországNo longer taking part
  • Hospital Universitario Dr. Peset AleixandreValencia, SpanyolországNo longer taking part
  • Hospital Universitario Y Politecnico La FeValencia, SpanyolországNo longer taking part
  • Hospital Universitario Rio HortegaValladolid, SpanyolországNo longer taking part
  • Complexo Hospitalario Universitario De VigoVigo, SpanyolországNo longer taking part
  • Hospital Clinico Universitario Lozano BlesaZaragoza, SpanyolországNo longer taking part
  • Hospital Unviersitario Miguel ServetZaragoza, SpanyolországNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Fundacio Privada Mon Clinic Barcelona
Trial code
EU 2023-507304-32-00
Record updated
2024. április 4.
Original description
To determine the efficacy of Trelegy® vs. LABA-LAMA treatment in improving clinical control (CC), a validated composite endpoint that includes two domains, stability, and impact, in COPD B+ patientsRead full original descriptionShow less

To determine the efficacy of Trelegy® vs. LABA-LAMA treatment in improving clinical control (CC), a validated composite endpoint that includes two domains, stability, and impact, in COPD B+ patients

Inclusion: Female or male; 40-80 yrs. of age; Current/former smokers ≥10 pack-year; Diagnosis of COPD according to GOLD 2023 (post-BD FEV1/FVC<0.7 in the appropriate clinical context) with FEV1 post-BD 30-70% of the reference value; B+ phenotype 1. CAT≥10 despite being on LABA-LAMA for ≥3 months, and 2. 1 moderate ECOPD in the previous year (treated with a short course of oral steroids and/or antibiotics), and 3. ≥150 blood Eos/L (as determined by a single Eos measurement in the previous 12 months available in the medical record of the patient); A signed and dated written informed consent prior to study participation.

Exclusion: GOLD E (≥2 moderate or 1 severe ECOPD in the previous year); Systemic, oral, parenteral corticosteroids used for COPD and/or other diseases in the last 8 weeks before entering in the study (oral/systemic corticosteroids may be used to treat COPD exacerbations during the study); ICS treatment (or oral steroid for whatever reason) during the last 8 weeks; Other concomitant respiratory disease (e.g., bronchiectasis, lung fibrosis, lung neoplasm); Use of domiciliary long-term oxygen therapy or non-invasive ventilation; Participation on Pulmonary Rehabilitation Program within 4 weeks prior to Screening or subjects who plan to enter the acute phase of a Pulmonary Rehabilitation Program during the study; Long term antibiotic therapy (antibiotics are allowed for the short-term treatment of an exacerbation or for short term treatment of other acute infections during the study); Any disease, disability, or geographic location that would limit compliance for scheduled visits; Known allergy to Trelegy® components (vilanterol, umeclidinium and/or fluticasone furoate) or inability to use the Ellipta® device; Current diagnosis of asthma or documented history of asthma in the medical record of the patient according to the 2023 Global Initiative for Asthma (GINA) guidelines or other accepted guidelines; Unstable or life-threatening cardiac disease, including: 1. Myocardial infarction or unstable angina in the last 6 months 2. Unstable or life-threatening cardiac arrhythmia requiring intervention in the last 3 months. 3. NYHA Class IV Heart failure; Active neoplasm; Life expectancy < 1 yr; Current participation in other RCTs; Non-compliance: subjects at risk of non-compliance, or unable to comply with the study procedures; Women who are pregnant or lactating or are planning to become pregnant during the study; ECOPD during the last 8 weeks; Alpha-1 antitrypsin deficiency.

EU CTIS 2023-507304-32-00