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+)

Chronic Obstructive Pulmonary Disease

To determine the existence of an association between the use of Trelegy® vs. LABA-LAMA treatment with being a patient persistently controlled by CC at all study visits (a subject to be a categorize as having clinical control they must meet the criteria at month 3, 6, 9 and 12).

To determine the existence of an association between the use of Trelegy® vs. LABA-LAMA treatment with being a patient persistently non deteriorated by CID-CAT at all study visits.(a subject to be a categorize as having control by CID-CAT they must meet the criteria a month 3, 6, 9 and 12)., To compare several Health status related endpoints between study arms including the existence of an association between the use of Trelegy vs. LABA-LAMA treatment with being a patient persistenly controlled (at all visits) throughout the study between the two study arms as per CC - Stability Domain (1.General status since the last visit and 2. Exacerbations in the last 3 months), To compare several Health status related endpoints between study arms including the existence of an association between the use of Trelegy vs. LABA-LAMA treatment with being a patient persistenly controlled (at all visits) throughout the study between the two study arms as per CC - Impact Domain (1.Sputum color, 2. Rescue Medication, 3. Minute walked per day and 4. Dyspnea (mMRC))), To compare several Health status related endpoints between study arms including the existence of an association between the use of Trelegy vs. LABA-LAMA treatment with being a patient persistenly controlled (at all visits) throughout the study between the two study arms as per CID-CAT – Exacerbations, To compare several Health status related endpoints between study arms including the existence of an association between the use of Trelegy vs. LABA-LAMA treatment with being a patient persistenly controlled (at all visits) throughout the study between the two study arms as per CID-CAT – PROs, To compare several Health status related endpoints between study arms including the existence of an association between the use of Trelegy vs. LABA-LAMA treatment with being a patient persistenly controlled (at all visits) throughout the study between the two study arms as per CID-CAT – Lung function, To compare several Health status related endpoints between study arms including: To evaluate time to first not being CC or suffer CID-CAT, To compare several Health status related endpoints between study arms including evaluate the time to first not achievement event for CC - Stability Domain (1. General status since the last visit and 2. Exacerbations in the last 3 months), To compare several Health status related endpoints between study arms including evaluate the time to first not achievement event for CC - Impact Domain (1. Sputum color, 2. Rescue medication use, 3. Minutes walked per day and 4. Dyspnea (mMRC)), To compare several Health status related endpoints between study arms including evaluate the time to first not achievement event for CID-CAT Exacerbations, To compare several Health status related endpoints between study arms including evaluate the time to first not achievement event for CID-CAT Spirometry, To compare several Health status related endpoints between study arms including to evaluate the mean and annual rate of: 1. Moderate exacerbations (ECOPD), 2. Severe ECOPD (hospitalized) and 3. Moderate and Severe ECOPD, To compare several Health status related endpoints between study arms including to evaluate time to first ECOPD including: 1. Moderate ECOPD, 2. Severe ECOPD (hospitalized) and 3. Moderate to Severe ECOPD, To compare several Health status related endpoints between study arms including to assess annual FEV1 and FVC changes (ml/year), To identify independent predictors with a potential negative impact on achieving the CC, each of its domains and each of its variables at each study visit.

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