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+)

Prior treatment

• GOLD E (≥2 moderate or 1 severe ECOPD in the previous year)
• Systemic, oral, parenteral corticosteroids used for COPD and/or other diseases in the last 8 weeks before entering in the study (oral/systemic corticosteroids may be used to treat COPD exacerbations during the study).
• ICS treatment (or oral steroid for whatever reason) during the last 8 weeks
• Other concomitant respiratory disease (e.g., bronchiectasis, lung fibrosis, lung neoplasm)
• Use of domiciliary long-term oxygen therapy or non-invasive ventilation
• 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.

Other illness

• 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).
• 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.
• 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
• Unstable or life-threatening cardiac disease, including: 1. Myocardial infarction or unstable angina in the last 6 months 2. Unstable or life-threatening cardiac arrhythmia requiring intervention in the last 3 months. 3. NYHA Class IV Heart failure.

Other

• Active neoplasm
• Life expectancy < 1 yr.
• Current participation in other RCTs
• Non-compliance: subjects at risk of non-compliance, or unable to comply with the study procedures.
• Women who are pregnant or lactating or are planning to become pregnant during the study.
• ECOPD during the last 8 weeks
• Alpha-1 antitrypsin deficiency

• Female or male
• 40-80 yrs. of age
• Current/former smokers ≥10 pack-year
• Diagnosis of COPD according to GOLD 2023 (post-BD FEV1/FVC<0.7 in the appropriate clinical context) with FEV1 post-BD 30-70% of the reference value
• B+ phenotype 1. CAT≥10 despite being on LABA-LAMA for ≥3 months, and 2. 1 moderate ECOPD in the previous year (treated with a short course of oral steroids and/or antibiotics), and 3. ≥150 blood Eos/L (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.