ANTES B+ Clinical Trial

NCT06282861 | Terminated Phase 4

• 2 other identifiers: ANTES B+2023-507304-32
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

COPD; ECOPD; eosinophil; Trelegy; Clinical Control

Outcome Measures

Primary Outcomes (1)

• Clinical Control (CC)

  Patient persistently controlled by CC at all study visits (a subject to be categorized as having clinical control they must meet the criteria at month 3, 6, 9 and 12).

  3,6,9 and 12 months

Secondary Outcomes (11)

• Clinical Important Deterioration (CID)

  3,6,9 and 12 months

• Patients persistently controlled

  3,6,9 and 12 months

• Time to deterioration

  3,6,9 and 12 months

• Time to no control event of CC - Stability Domain

  3,6,9 and 12 months

• Time to no control event of CC - Impact Domain

  3,6,9 and 12 months

Study Arms (2)

Trelegy

EXPERIMENTAL

Trelegy commercial product. 1 inhalation daily for 12 months

Drug: Trelegy Ellipta 100/62.5/25Mcg Inh 30D

LABA-LAMA

ACTIVE COMPARATOR

Any LABA-LAMA combination approved in Spain is accepted. To be used according to product specifications for 12 months.

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

Interventions

Trelegy Ellipta 100/62.5/25Mcg Inh 30D DRUG

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

Also known as: LABA/LAMA/ICS

Trelegy

Brimica DRUG

As per product specifications

Also known as: LABA/LAMA

LABA-LAMA

Duaklir DRUG

As per product specifications

Also known as: LABA/LAMA

LABA-LAMA

Ultibro DRUG

As per product specifications

Also known as: LABA/LAMA

LABA-LAMA

Ulunar DRUG

As per product specifications

Also known as: LABA/LAMA

LABA-LAMA

Xoterna DRUG

As per product specifications

Also known as: LABA/LAMA

LABA-LAMA

Anoro DRUG

As per product specifications

Also known as: LABA/LAMA

LABA-LAMA

Laventair DRUG

As per product specifications

Also known as: LABA/LAMA

LABA-LAMA

Spiolto Respimat DRUG

As per product specifications

Also known as: LABA/LAMA

LABA-LAMA

Yanimo DRUG

As per product specifications

Also known as: LABA/LAMA

LABA-LAMA

Foradil DRUG

As per product specifications

Also known as: LABA

LABA-LAMA

Broncoral DRUG

As per product specifications

Also known as: LABA

LABA-LAMA

Formoterol stada DRUG

As per product specifications

Also known as: LABA

LABA-LAMA

Oxis DRUG

As per product specifications

Also known as: LABA

LABA-LAMA

Formatris DRUG

As per product specifications

Also known as: LABA

LABA-LAMA

Formoterol Aldo DRUG

As per product specifications

Also known as: LABA

LABA-LAMA

Onbrez DRUG

As per product specifications

Also known as: LABA

LABA-LAMA

Oslif DRUG

As per product specifications

Also known as: LABA

LABA-LAMA

Hirobriz DRUG

As per product specifications

Also known as: LABA

LABA-LAMA

Striverdi DRUG

As per product specifications

Also known as: LABA

LABA-LAMA

Beglan DRUG

As per product specifications

Also known as: LABA

LABA-LAMA

Betamican DRUG

As per product specifications

Also known as: LABA

LABA-LAMA

Inaspir DRUG

As per product specifications

Also known as: LABA

LABA-LAMA

Serevent DRUG

As per product specifications

Also known as: LABA

LABA-LAMA

Soltel DRUG

As per product specifications

Also known as: LABA

LABA-LAMA

Eklira DRUG

As per product specifications

Also known as: LAMA

LABA-LAMA

Bretaris DRUG

As per product specifications

Also known as: LAMA

LABA-LAMA

Seebri DRUG

As per product specifications

Also known as: LAMA

LABA-LAMA

Tovanor DRUG

As per product specifications

Also known as: LAMA

LABA-LAMA

Enurev DRUG

As per product specifications

Also known as: LAMA

LABA-LAMA

Spiriva DRUG

As per product specifications

Also known as: LAMA

LABA-LAMA

Tavulus DRUG

As per product specifications

Also known as: LAMA

LABA-LAMA

Sirkava DRUG

As per product specifications

Also known as: LAMA

LABA-LAMA

Braltus DRUG

As per product specifications

Also known as: LAMA

LABA-LAMA

Gregal DRUG

As per product specifications

Also known as: LAMA

LABA-LAMA

Incruse DRUG

As per product specifications

Also known as: LAMA

LABA-LAMA

Rolufta DRUG

As per product specifications

Also known as: LAMA

LABA-LAMA

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male
• yrs. of age
• Current/former smokers ≥10 pack-year
• Diagnosis of COPD according to GOLD 2023 (post-bronchodilator(BD) FEV1/FVC\<0.7 in the appropriate clinical context) with FEV1 post-BD 30-70% of the reference value
• B+ phenotype
• CAT≥10 despite being on LABA-LAMA for ≥3 months, and
• moderate ECOPD in the previous year (treated with a short course of oral steroids and/or antibiotics), and
• ≥150 blood Eos/ μL (as determined by a single Eos measurement in the previous 12 months available in the medical record of the patient)
• A signed and dated written informed consent prior to study participation.

You may not qualify if:

• GOLD E (≥2 moderate or 1 severe ECOPD in the previous year)
• ICS treatment (or oral steroid for whatever reason) during the last 8 weeks (10)
• ECOPD during the last 8 weeks
• Current diagnosis of asthma or documented history of asthma in the medical record of the patient according to the 2023 Global Initiative for Asthma (GINA) guidelines or other accepted guidelines
• Other concomitant respiratory disease (e.g., bronchiectasis, lung fibrosis, lung neoplasm)
• Use of domiciliary long-term oxygen therapy or non-invasive ventilation
• Alpha-1 antitrypsin deficiency
• Unstable or life-threatening cardiac disease, including:
• Myocardial infarction or unstable angina in the last 6 months
• Unstable or life-threatening cardiac arrhythmia requiring intervention in the last 3 months.
• New York Heart Association (NYHA) Class IV Heart failure.
• Participation on Pulmonary Rehabilitation Program within 4 weeks prior to Screening or subjects who plan to enter the acute phase of a Pulmonary Rehabilitation Program during the study.
• Long term antibiotic therapy (antibiotics are allowed for the short-term treatment of an exacerbation or for short term treatment of other acute infections during the study).
• Systemic, oral, parenteral corticosteroids used for COPD and/or other diseases in the 8 weeks before entering in the study (oral/systemic corticosteroids may be used to treat COPD exacerbations during the study).
• Active neoplasm

Sponsors & Collaborators

• Fundacio Privada Mon Clinic Barcelona: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Hospital Clínic Barcelona

Barcelona, Catalonia, 08036, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

tiotropium-olodaterol; Formoterol Fumarate; indacaterol; olodaterol; Salmeterol Xinafoate; Glycopyrrolate; Tiotropium Bromide; GSK573719

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Albuterol; Phenethylamines; Ethylamines; Quaternary Ammonium Compounds; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Àlvar Agustí

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase IV, open-label, prospective, pragmatic, interventional, randomized (1:1), multicenter, controlled, 12-month follow-up trial.

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 28, 2024
• Study Start: February 29, 2024
• Primary Completion: January 23, 2025
• Study Completion: January 23, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)