ANTES B+ Clinical Trial - Trial NCT06282861

Timeline & Enrollment

Primary Outcome

Clinical Control (CC)

Summary

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.

ICD-10 Classifications