AI Article Synopsis
- The ANTES B+ study evaluates whether adding an inhaled corticosteroid (ICS) to a combination of long-acting beta agonist (LABA) and long-acting muscarinic antagonist (LAMA) improves clinical control in GOLD B COPD patients who are still symptomatic despite current treatment.
- It will involve 1028 patients who will either continue their current LABA/LAMA regimen or switch to a new triple therapy for a year, measuring outcomes like clinical control, exacerbation rates, and lung function.
- The study is significant as it is the first to test this approach in a specific COPD patient group and to use a composite index to measure primary outcomes, with results expected by early 2026.
Article Abstract
Introduction: Treatment with LABA/LAMA is recommended in GOLD B patients. We hypothesized that triple therapy (LABA/LAMA/ICS) will be superior to LABA/LAMA in achieving and maintaining clinical control (CC), a composite outcome that considers both impact and disease stability in a subgroup of GOLD B patients (here termed GOLD B+ patients) characterized by: (1) remaining symptomatic (CAT≥10) despite regular LABA/LAMA therapy; (2) having suffered one moderate exacerbation in the previous year; and (3) having blood eosinophil counts (BEC) ≥150cells/μL.
Methods: The ANTES B+ study is a prospective, multicenter, open label, randomized, pragmatic, controlled trial designed to test this hypothesis. It will randomize 1028 B+ patients to continue with their usual LABA/LAMA combination prescribed by their attending physician or to begin fluticasone furoate (FF) 92μg/umeclidinium (UMEC) 55μg/vilanterol (VI) 22μg in a single inhaler q.d. for 12 months. The primary efficacy outcome will be the level of CC achieved. Secondary outcomes include the clinical important deterioration index (CID), annual rate of exacerbations, and FEV1. Exploratory objectives include the interaction of BEC and smoking status, all-cause mortality and proportion of patients on LABA/LAMA arm that switch therapy arms. Safety analysis include adverse events and incidence of pneumonia.
Results: The first patient was recruited on February 29, 2024; results are expected in the first quarter of 2026.
Conclusions: The ANTES B+ study is the first to: (1) explore the efficacy and safety of triple therapy in a population of B+ COPD patients and (2) use a composite index (CC) as the primary result of a COPD trial.
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| http://dx.doi.org/10.1016/j.arbres.2024.04.008 | DOI Listing |
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