ANTES B+ Clinical Trial

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

DRUG

Trelegy Ellipta 100/62.5/25Mcg Inh 30D

Product to be used according to specifications. 1 inhalation daily for 12 months

DRUG

Brimica

As per product specifications

DRUG

Duaklir

As per product specifications

DRUG

Ultibro

As per product specifications

DRUG

Ulunar

As per product specifications

DRUG

Xoterna

As per product specifications

DRUG

Anoro

As per product specifications

DRUG

Laventair

As per product specifications

DRUG

Spiolto Respimat

As per product specifications

DRUG

Yanimo

As per product specifications

DRUG

Foradil

As per product specifications

DRUG

Broncoral

As per product specifications

DRUG

Formoterol stada

As per product specifications

DRUG

Oxis

As per product specifications

DRUG

Formatris

As per product specifications

DRUG

Formoterol Aldo

As per product specifications

DRUG

Onbrez

As per product specifications

DRUG

Oslif

As per product specifications

DRUG

Hirobriz

As per product specifications

DRUG

Striverdi

As per product specifications

DRUG

Beglan

As per product specifications

DRUG

Betamican

As per product specifications

DRUG

Inaspir

As per product specifications

DRUG

Serevent

As per product specifications

DRUG

Soltel

As per product specifications

DRUG

Eklira

As per product specifications

DRUG

Bretaris

As per product specifications

DRUG

Seebri

As per product specifications

DRUG

Tovanor

As per product specifications

DRUG

Enurev

As per product specifications

DRUG

Spiriva

As per product specifications

DRUG

Tavulus

As per product specifications

DRUG

Sirkava

As per product specifications

DRUG

Braltus

As per product specifications

DRUG

Gregal

As per product specifications

DRUG

Incruse

As per product specifications

DRUG

Rolufta

As per product specifications

Sponsors & Collaborators

• GlaxoSmithKline

  collaborator INDUSTRY

• Fundacio Privada Mon Clinic Barcelona

  lead OTHER

Principal Investigators

• Àlvar Agustí · Hospital Clinic of Barcelona

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-29

Primary Completion

2025-01-23

Completion

2025-01-23

Countries

• Spain

Study Locations