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Chronic Obstructive Pulmonary DiseasePhase 4ANTES B+NCT06282861

ANTES B+ Clinical Trial

A Phase 4 study testing Trelegy Ellipta 100/62.5/25Mcg Inh 30D, Brimica and Duaklir in people with Chronic Obstructive Pulmonary Disease, run by Fundacio Privada Mon Clinic Barcelona at 1 site in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Trelegy Ellipta 100/62.5/25Mcg Inh 30D, Brimica and Duaklir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteSpain
Study dates
29 Feb 2024to 23 Jan 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • 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
Show all 21Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Clínic Barcelona

    Barcelona, Catalonia, 08036

Other trials in Spain

About this study

Official title: 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).
Read more

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.

Being tested
Trelegy Ellipta 100/62.5/25Mcg Inh 30D, Brimica, Duaklir, Ultibro, Ulunar
Keywords
COPD, ECOPD, eosinophil, Trelegy, Clinical Control
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trelegy Ellipta 100/62.5/25Mcg Inh 30DDrug

    Also called LABA/LAMA/ICS

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

  • BrimicaDrug

    Also called LABA/LAMA

    As per product specifications

  • DuaklirDrug

    Also called LABA/LAMA

    As per product specifications

  • UltibroDrug

    Also called LABA/LAMA

    As per product specifications

  • UlunarDrug

    Also called LABA/LAMA

    As per product specifications

  • XoternaDrug

    Also called LABA/LAMA

    As per product specifications

  • AnoroDrug

    Also called LABA/LAMA

    As per product specifications

  • LaventairDrug

    Also called LABA/LAMA

    As per product specifications

  • Spiolto RespimatDrug

    Also called LABA/LAMA

    As per product specifications

  • YanimoDrug

    Also called LABA/LAMA

    As per product specifications

  • ForadilDrug

    Also called LABA

    As per product specifications

  • BroncoralDrug

    Also called LABA

    As per product specifications

  • Formoterol stadaDrug

    Also called LABA

    As per product specifications

  • OxisDrug

    Also called LABA

    As per product specifications

  • FormatrisDrug

    Also called LABA

    As per product specifications

  • Formoterol AldoDrug

    Also called LABA

    As per product specifications

  • OnbrezDrug

    Also called LABA

    As per product specifications

  • OslifDrug

    Also called LABA

    As per product specifications

  • HirobrizDrug

    Also called LABA

    As per product specifications

  • StriverdiDrug

    Also called LABA

    As per product specifications

  • BeglanDrug

    Also called LABA

    As per product specifications

  • BetamicanDrug

    Also called LABA

    As per product specifications

  • InaspirDrug

    Also called LABA

    As per product specifications

  • SereventDrug

    Also called LABA

    As per product specifications

  • SoltelDrug

    Also called LABA

    As per product specifications

  • EkliraDrug

    Also called LAMA

    As per product specifications

  • BretarisDrug

    Also called LAMA

    As per product specifications

  • SeebriDrug

    Also called LAMA

    As per product specifications

  • TovanorDrug

    Also called LAMA

    As per product specifications

  • EnurevDrug

    Also called LAMA

    As per product specifications

  • SpirivaDrug

    Also called LAMA

    As per product specifications

  • TavulusDrug

    Also called LAMA

    As per product specifications

  • SirkavaDrug

    Also called LAMA

    As per product specifications

  • BraltusDrug

    Also called LAMA

    As per product specifications

  • GregalDrug

    Also called LAMA

    As per product specifications

  • IncruseDrug

    Also called LAMA

    As per product specifications

  • RoluftaDrug

    Also called LAMA

    As per product specifications

Study groups in NCT06282861
Study groupRoleWhat they receive
TrelegyExperimentalTrelegy commercial product. 1 inhalation daily for 12 months
Receives: Drug: Trelegy Ellipta 100/62.5/25Mcg Inh 30D
LABA-LAMAActive comparatorAny LABA-LAMA combination approved in Spain is accepted. To be used according to product specifications for 12 months.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 3,6,9 and 12 months

Secondary outcomes (11)

  1. Clinical Important Deterioration (CID)

    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).

    Measured: 3,6,9 and 12 months

  2. Patients persistently controlled

    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

    Measured: 3,6,9 and 12 months

  3. Time to deterioration

    time to first event of not being CC or suffer CID-CAT

    Measured: 3,6,9 and 12 months

  4. Time to no control event of CC - Stability Domain

    Time to first no control event for CC - Stability Domain

    Measured: 3,6,9 and 12 months

  5. Time to no control event of CC - Impact Domain

    Time to first no control event for CC - Impact Domain

    Measured: 3,6,9 and 12 months

  6. Time to deterioration event of CID-CAT Exacerbations

    Time to deterioration event for CID-CAT Exacerbations

    Measured: 3,6,9 and 12 months

  7. Time to deterioration event of CID-CAT Spirometry

    Time to deterioration event for CID-CAT Spirometry

    Measured: 3,6,9 and 12 months

  8. Exacerbation rate

    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

    Measured: 3,6,9 and 12 months

  9. Time to first Exacerbation

    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

    Measured: 3,6,9 and 12 months

  10. Spirometry changes

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

    1. To assess annual FEV1(Forced Expiratory volume) and FVC (forced vital capacity) changes (ml/year)

    Measured: 3,6,9 and 12 months

  11. Independent predictors

    Independent predictors with a potential negative impact on achieving the CC, each of its domains and each of its variables at each study visit.

    Measured: 3,6,9 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start29 Feb 2024
  3. Primary completion23 Jan 2025
  4. Study completion23 Jan 2025

Why it stopped: Delays in the opening and activation of participating sites, and a low recruitment rate, with only 48 participants enrolled over the course of one year

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase IV, open-label, prospective, pragmatic, interventional, randomized (1:1), multicenter, controlled, 12-month follow-up trial.
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06282861
Sponsor's protocol ID
ANTES B+
Other IDs
2023-507304-32, 2023
Acronym
ANTES B+
Status last verified
Aug 2025
First submitted
13 Feb 2024
Last updated
14 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Trelegy Ellipta 100/62.5/25Mcg Inh 30D, Brimica and Duaklir in people with Chronic Obstructive Pulmonary Disease, run by Fundacio Privada Mon Clinic Barcelona at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Delays in the opening and activation of participating sites, and a low recruitment rate, with only 48 participants enrolled over the course of one year). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Control (CC) (time frame: 3,6,9 and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06282861.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025; AzTrials last refreshed its copy on 3 Nov 2026.

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