ANTES B+ Clinical Trial

Fundacio Privada Mon Clinic Barcelona

Status and phase

Enrolling

Phase 4

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: Incruse

Drug: Oxis

Drug: Bretaris

Drug: Brimica

Drug: Spiolto Respimat

Drug: Eklira

Drug: Enurev

Drug: Tovanor

Drug: Ultibro

Drug: Oslif

Drug: Formoterol stada

Drug: Soltel

Drug: Rolufta

Drug: Betamican

Drug: Onbrez

Drug: Gregal

Drug: Formatris

Drug: Anoro

Drug: Beglan

Drug: Laventair

Drug: Broncoral

Drug: Inaspir

Drug: Hirobriz

Drug: Foradil

Drug: Ulunar

Drug: Serevent

Drug: Striverdi

Drug: Tavulus

Drug: Spiriva

Drug: Sirkava

Drug: Duaklir

Drug: Yanimo

Drug: Formoterol Aldo

Drug: Seebri

Drug: Braltus

Drug: Trelegy Ellipta 100/62.5/25Mcg Inh 30D

Drug: Xoterna

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06282861

2023-507304-32 (EudraCT Number)

ANTES B+

Details and patient eligibility

About

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.

Enrollment

1,028 estimated patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,028 participants in 2 patient groups

Trelegy

Experimental group

Description:

Trelegy commercial product. 1 inhalation daily for 12 months

Treatment: