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/ml the 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
48
Product to be used according to specifications. 1 inhalation daily for 12 months
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Hospital Clínic Barcelona
Barcelona, Catalonia, Spain
Clinical Control (CC)
Patient persistently controlled by CC at all study visits (a subject to be categorized as having clinical control they must meet the criteria at month 3, 6, 9 and 12).
Time frame: 3,6,9 and 12 months
Clinical Important Deterioration (CID)
Patients persistently non deteriorated by CID-CAT at all study visits.(a subject to be categorized as having control by CID-CAT they must meet the criteria a month 3, 6, 9 and 12).
Time frame: 3,6,9 and 12 months
Patients persistently controlled
Patients persistently controlled (at all visits) throughout the study between the two study arms as per: * CC - Stability Domain 1. General status since the last visit 2. Exacerbations in the last 3 months * CC - Impact Domain 1. Sputum color 2. Rescue medication use 3. Minutes walked per day 4. Dyspnea (mMRC) * CID-CAT - Exacerbations * CID-CAT - (Patient reported outcomes)PROs * CID-CAT - Lung function
Time frame: 3,6,9 and 12 months
Time to deterioration
time to first event of not being CC or suffer CID-CAT
Time frame: 3,6,9 and 12 months
Time to no control event of CC - Stability Domain
Time to first no control event for CC - Stability Domain
Time frame: 3,6,9 and 12 months
Time to no control event of CC - Impact Domain
Time to first no control event for CC - Impact Domain
Time frame: 3,6,9 and 12 months
Time to deterioration event of CID-CAT Exacerbations
Time to deterioration event for CID-CAT Exacerbations
Time frame: 3,6,9 and 12 months
Time to deterioration event of CID-CAT Spirometry
Time to deterioration event for CID-CAT Spirometry
Time frame: 3,6,9 and 12 months
Exacerbation rate
To compare several Health status related endpoints between study arms including: d.To evaluate the mean and annual rate of: * Moderate exacerbations (ECOPD) * Severe ECOPD (hospitalized) * Moderate and Severe ECOPD
Time frame: 3,6,9 and 12 months
Time to first Exacerbation
To compare several Health status related endpoints between study arms including: e.To evaluate time to first ECOPD including: * Moderate ECOPD * Severe ECOPD (hospitalized) * Moderate or Severe ECOPD
Time frame: 3,6,9 and 12 months
Spirometry changes
To compare several Health status related endpoints between study arms including: f. To assess annual FEV1(Forced Expiratory volume) and FVC (forced vital capacity) changes (ml/year)
Time frame: 3,6,9 and 12 months
Independent predictors
Independent predictors with a potential negative impact on achieving the CC, each of its domains and each of its variables at each study visit.
Time frame: 3,6,9 and 12 months
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