NCT06282861

ANTES B+ Clinical Trial

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+)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Fundacio Privada Mon Clinic Barcelona · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2024-02-29
• Primary completion: 2025-01-23
• Completion: 2025-01-23
• First posted: 2024-02-28
• Last updated: 2025-08-14

Locations

1 site across 1 country: Spain