ANTES B+ Clinical Trial (ANTES B+)

March 4, 2024 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1028

Phase

  • 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 Locations

  • Spain
    • Catalunya
      • Barcelona, Catalunya, Spain, 08036
        • Recruiting
        • Hospital Clinic Barcelona
        • Contact:
        • Contact:
          • Nestor Soler

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

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
Intervention / Treatment
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

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

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

Fundacio Privada Mon Clinic Barcelona

Collaborators

GlaxoSmithKline

Investigators

  • 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)

February 29, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

February 13, 2024

First Submitted That Met QC Criteria

February 21, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANTES B+
  • 2023-507304-32 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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