Loading clinical trials...
Loading clinical trials...
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+)
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.
Age
40 - 80 years
Sex
ALL
Healthy Volunteers
No
Hospital Clínic Barcelona
Barcelona, Catalonia, Spain
Start Date
February 29, 2024
Primary Completion Date
January 23, 2025
Completion Date
January 23, 2025
Last Updated
August 14, 2025
48
ACTUAL participants
Trelegy Ellipta 100/62.5/25Mcg Inh 30D
DRUG
Brimica
DRUG
Duaklir
DRUG
Ultibro
DRUG
Ulunar
DRUG
Xoterna
DRUG
Anoro
DRUG
Laventair
DRUG
Spiolto Respimat
DRUG
Yanimo
DRUG
Foradil
DRUG
Broncoral
DRUG
Formoterol stada
DRUG
Oxis
DRUG
Formatris
DRUG
Formoterol Aldo
DRUG
Onbrez
DRUG
Oslif
DRUG
Hirobriz
DRUG
Striverdi
DRUG
Beglan
DRUG
Betamican
DRUG
Inaspir
DRUG
Serevent
DRUG
Soltel
DRUG
Eklira
DRUG
Bretaris
DRUG
Seebri
DRUG
Tovanor
DRUG
Enurev
DRUG
Spiriva
DRUG
Tavulus
DRUG
Sirkava
DRUG
Braltus
DRUG
Gregal
DRUG
Incruse
DRUG
Rolufta
DRUG
Lead Sponsor
Fundacio Privada Mon Clinic Barcelona
Collaborators
NCT07477600
NCT05878769
NCT06717659
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions