Comparing triple therapy to double therapy for COPD patients at high risk

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+)

This study is testing if a new triple therapy called Trelegy can help adults with COPD who are at high risk feel better compared to the usual double therapy they currently receive.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 1028 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Fundacio Privada Mon Clinic Barcelona (other)
• Locations: 1 site (Barcelona, Catalunya)
• Trial ID: NCT06282861 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of Trelegy, a triple therapy treatment, in patients with Chronic Obstructive Pulmonary Disease (COPD) who are classified as B+ and at high risk for poor clinical control. The study aims to compare the clinical outcomes of these patients receiving Trelegy against those receiving standard dual therapy (LABA-LAMA). Eligible participants are adults aged 40-80 with specific criteria, including a history of moderate exacerbations and elevated eosinophil levels. The primary goal is to assess improvements in clinical control using a validated composite endpoint.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 40-80 with a diagnosis of COPD who have experienced one moderate exacerbation in the past year and have elevated eosinophil levels despite current treatment.

Not a fit: Patients with more severe COPD (GOLD E) or those currently on inhaled corticosteroids may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for COPD patients at high risk of exacerbations, potentially improving their quality of life.

How similar studies have performed: Other studies have shown promising results with triple therapy in COPD, suggesting that this approach may be beneficial for specific patient subgroups.

Eligibility criteria

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.

Where this trial is running

Barcelona, Catalunya

• Hospital Clínic Barcelona — Barcelona, Catalunya, Spain (RECRUITING)

Study contacts

• Principal investigator: Àlvar Agustí — Hospital Clinic of Barcelona
• Study coordinator: Lada Murcia Rosero

Conditions: Chronic Obstructive Pulmonary Disease, COPD, ECOPD, eosinophil, Trelegy, Clinical Control