Population under study: Patients with chronic obstructive pulmonary disease (COPD) who remain symptomatic (CAT=10) despite current treatment with dual long-acting bronchodilator therapy with LABA-LAMA, have suffered 1 moderate COPD exacerbation in the previous year (treated with oral corticosteroids and/or antibiotics), and have a blood eosinophil count =150 Eos/?L. A total of 1028 patients from 40 to 80 years old will be included.
Phase and design: Phase IV, open-label, prospective, pragmatic, interventional, randomized (1:1), multicenter, controlled, 12-month duration study.
Investigational drug: Trelegy®
Auxiliary medications: None
Primary objective: 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 (as detailed below).
Primary endpoint: 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).