protocolSection identificationModule nctId: NCT06282861, orgStudyIdInfo id: ANTES B+, secondaryIdInfos id: 2023-507304-32, type: EUDRACT_NUMBER, briefTitle: ANTES B+ Clinical Trial, acronym: ANTES B+, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Fundacio Privada Mon Clinic Barcelona, class: OTHER, collaborators name: GlaxoSmithKline, descriptionModule briefSummary: Current guidelines recommend initial treatment with dual long-acting bronchodilator therapy (LABA-LAMA) in patients with Chronic Obstructive Pulmonary Disease (COPD) of group B (defined by CAT≥10 and none or 1 moderate exacerbation). However, the investigators hypothesize that there is a subgroup of B patients (B+) at a particularly high risk for poor clinical control, characterized by the following:* 1 moderate exacerbation in the previous year* CAT≥10 despite current treatment with LABA -LAMA* Blood eosinophil levels of ≥150 cells/mlthe investigators further hypothesize that B+ patients could benefit from triple therapy treatment (LABA-LAMA + Inhaled Corticosteroids). Therefore, the main goal of this clinical trial is to compare the efficacy of Trelegy (triple therapy) in improving clinical control in GOLD B+ patients with chronic obstructive disease when compared to standard double therapy (LABA -LAMA).The clinical control is a validated composite endpoint that includes two domains, the patient's stability, and the impact of the disease.1028 patients will be randomly allocated to receive either the standard therapy or Trelegy and will be monitored by the investigators for 1 year in 2 on-site visits + 2 remote visits., conditionsModule conditions: Chronic Obstructive Pulmonary Disease, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Phase IV, open-label, prospective, pragmatic, interventional, randomized (1:1), multicenter, controlled, 12-month follow-up trial., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 1028, type: ESTIMATED, armsInterventionsModule interventions name: Trelegy Ellipta 100/62.5/25Mcg Inh 30D, interventions name: Brimica, interventions name: Duaklir, interventions name: Ultibro, interventions name: Ulunar, interventions name: Xoterna, interventions name: Anoro, interventions name: Laventair, interventions name: Spiolto Respimat, interventions name: Yanimo, interventions name: Foradil, interventions name: Broncoral, interventions name: Formoterol stada, interventions name: Oxis, interventions name: Formatris, interventions name: Formoterol Aldo, interventions name: Onbrez, interventions name: Oslif, interventions name: Hirobriz, interventions name: Striverdi, interventions name: Beglan, interventions name: Betamican, interventions name: Inaspir, interventions name: Serevent, interventions name: Soltel, interventions name: Eklira, interventions name: Bretaris, interventions name: Seebri, interventions name: Tovanor, interventions name: Enurev, interventions name: Spiriva, interventions name: Tavulus, interventions name: Sirkava, interventions name: Braltus, interventions name: Gregal, interventions name: Incruse, interventions name: Rolufta, outcomesModule primaryOutcomes measure: Clinical Control (CC), secondaryOutcomes measure: Clinical Important Deterioration (CID), secondaryOutcomes measure: Patients persistently controlled, secondaryOutcomes measure: Time to deterioration, secondaryOutcomes measure: Time to no control event of CC - Stability Domain, secondaryOutcomes measure: Time to no control event of CC - Impact Domain, secondaryOutcomes measure: Time to deterioration event of CID-CAT Exacerbations, secondaryOutcomes measure: Time to deterioration event of CID-CAT Spirometry, secondaryOutcomes measure: Exacerbation rate, secondaryOutcomes measure: Time to first Exacerbation, secondaryOutcomes measure: Spirometry changes, secondaryOutcomes measure: Independent predictors, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Clínic Barcelona, status: RECRUITING, city: Barcelona, state: Catalunya, zip: 08036, country: Spain, contacts name: Àlvar Agustí, role: CONTACT, phone: 93 227 57 79, email: aagusti@clinic.cat, contacts name: Nestor Soler, role: CONTACT, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False