ANTES B+ Clinical Trial (ANTES B+)

August 11, 2025 updated by: Fundacio Privada Mon Clinic Barcelona

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
    • Catalunya
      • Barcelona, Catalunya, Spain, 08036
        • Hospital Clinic Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female or male
  • 40-80 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
    • 1 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.

Exclusion Criteria:

  • 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
  • Life expectancy < 1 yr.
  • Current participation in other RCTs (randomized clinical trial)
  • Non-compliance: subjects at risk of non-compliance, or unable to comply with the study procedures.
  • Any disease, disability, or geographic location that would limit compliance for scheduled visits.
  • Known allergy to Trelegy® components (vilanterol, umeclidinium and/or fluticasone furoate) or inability to use the Ellipta® device.
  • Women who are pregnant or lactating or are planning to become pregnant during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Trelegy
Trelegy commercial product. 1 inhalation daily for 12 months
Drug: Trelegy Ellipta 100/62.5/25Mcg Inh 30D
Product to be used according to specifications. 1 inhalation daily for 12 months
Other Names:
  • LABA/LAMA/ICS
Active Comparator: LABA-LAMA
Any LABA-LAMA combination approved in Spain is accepted. To be used according to product specifications for 12 months.
Drug: Brimica
As per product specifications
Other Names:
  • LABA/LAMA
Drug: Duaklir
As per product specifications
Other Names:
  • LABA/LAMA
Drug: Ultibro
As per product specifications
Other Names:
  • LABA/LAMA
Drug: Ulunar
As per product specifications
Other Names:
  • LABA/LAMA
Drug: Xoterna
As per product specifications
Other Names:
  • LABA/LAMA
Drug: Anoro
As per product specifications
Other Names:
  • LABA/LAMA
Drug: Laventair
As per product specifications
Other Names:
  • LABA/LAMA
Drug: Spiolto Respimat
As per product specifications
Other Names:
  • LABA/LAMA
Drug: Yanimo
As per product specifications
Other Names:
  • LABA/LAMA
Drug: Foradil
As per product specifications
Other Names:
  • LABA
Drug: Broncoral
As per product specifications
Other Names:
  • LABA
Drug: Formoterol stada
As per product specifications
Other Names:
  • LABA
Drug: Oxis
As per product specifications
Other Names:
  • LABA
Drug: Formatris
As per product specifications
Other Names:
  • LABA
Drug: Formoterol Aldo
As per product specifications
Other Names:
  • LABA
Drug: Onbrez
As per product specifications
Other Names:
  • LABA
Drug: Oslif
As per product specifications
Other Names:
  • LABA
Drug: Hirobriz
As per product specifications
Other Names:
  • LABA
Drug: Striverdi
As per product specifications
Other Names:
  • LABA
Drug: Beglan
As per product specifications
Other Names:
  • LABA
Drug: Betamican
As per product specifications
Other Names:
  • LABA
Drug: Inaspir
As per product specifications
Other Names:
  • LABA
Drug: Serevent
As per product specifications
Other Names:
  • LABA
Drug: Soltel
As per product specifications
Other Names:
  • LABA
Drug: Eklira
As per product specifications
Other Names:
  • LAMA
Drug: Bretaris
As per product specifications
Other Names:
  • LAMA
Drug: Seebri
As per product specifications
Other Names:
  • LAMA
Drug: Tovanor
As per product specifications
Other Names:
  • LAMA
Drug: Enurev
As per product specifications
Other Names:
  • LAMA
Drug: Spiriva
As per product specifications
Other Names:
  • LAMA
Drug: Tavulus
As per product specifications
Other Names:
  • LAMA
Drug: Sirkava
As per product specifications
Other Names:
  • LAMA
Drug: Braltus
As per product specifications
Other Names:
  • LAMA
Drug: Gregal
As per product specifications
Other Names:
  • LAMA
Drug: Incruse
As per product specifications
Other Names:
  • LAMA
Drug: Rolufta
As per product specifications
Other Names:
  • LAMA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical Control (CC)
Time Frame: 3,6,9 and 12 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Important Deterioration (CID)
Time Frame: 3,6,9 and 12 months
Patients persistently non deteriorated by CID-CAT at all study visits.(a subject to be categorized as having control by CID-CAT they must meet the criteria a month 3, 6, 9 and 12).
3,6,9 and 12 months
Patients persistently controlled
Time Frame: 3,6,9 and 12 months

Patients persistently controlled (at all visits) throughout the study between the two study arms as per:

  • CC - Stability Domain

    1. General status since the last visit
    2. Exacerbations in the last 3 months

  • CC - Impact Domain

    1. Sputum color
    2. Rescue medication use
    3. Minutes walked per day
    4. Dyspnea (mMRC)
  • CID-CAT - Exacerbations
  • CID-CAT - (Patient reported outcomes)PROs
  • CID-CAT - Lung function
3,6,9 and 12 months
Time to deterioration
Time Frame: 3,6,9 and 12 months
time to first event of not being CC or suffer CID-CAT
3,6,9 and 12 months
Time to no control event of CC - Stability Domain
Time Frame: 3,6,9 and 12 months
Time to first no control event for CC - Stability Domain
3,6,9 and 12 months
Time to no control event of CC - Impact Domain
Time Frame: 3,6,9 and 12 months
Time to first no control event for CC - Impact Domain
3,6,9 and 12 months
Time to deterioration event of CID-CAT Exacerbations
Time Frame: 3,6,9 and 12 months
Time to deterioration event for CID-CAT Exacerbations
3,6,9 and 12 months
Time to deterioration event of CID-CAT Spirometry
Time Frame: 3,6,9 and 12 months
Time to deterioration event for CID-CAT Spirometry
3,6,9 and 12 months
Exacerbation rate
Time Frame: 3,6,9 and 12 months

To compare several Health status related endpoints between study arms including:

d.To evaluate the mean and annual rate of:

  • Moderate exacerbations (ECOPD)
  • Severe ECOPD (hospitalized)
  • Moderate and Severe ECOPD
3,6,9 and 12 months
Time to first Exacerbation
Time Frame: 3,6,9 and 12 months

To compare several Health status related endpoints between study arms including:

e.To evaluate time to first ECOPD including:

  • Moderate ECOPD
  • Severe ECOPD (hospitalized)
  • Moderate or Severe ECOPD
3,6,9 and 12 months
Spirometry changes
Time Frame: 3,6,9 and 12 months

To compare several Health status related endpoints between study arms including:

f. To assess annual FEV1(Forced Expiratory volume) and FVC (forced vital capacity) changes (ml/year)
3,6,9 and 12 months
Independent predictors
Time Frame: 3,6,9 and 12 months
Independent predictors with a potential negative impact on achieving the CC, each of its domains and each of its variables at each study visit.
3,6,9 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundacio Privada Mon Clinic Barcelona

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GlaxoSmithKline

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Àlvar Agustí, Hospital Clinic of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 29, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 23, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 23, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ANTES B+
  • 2023-507304-32 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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