ANTES B+ Clinical Trial

Chronic Obstructive Pulmonary Disease Clinical Trial

— ANTES B+  

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+)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06282861
• Other study ID #: ANTES B+
• Secondary ID: 2023-507304-32
• Status: Recruiting
• Phase: Phase 4
• Start date: February 29, 2024
• Est. completion date: September 2025

Study information

• Verified date: March 2024
• Source: Fundacio Privada Mon Clinic Barcelona
• Contact: Lada Murcia Rosero
• Phone: 645093750
• Email: lmurcia[@]bcccbarcelona.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1028
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Trelegy Ellipta 100/62.5/25Mcg Inh 30D
Product to be used according to specifications. 1 inhalation daily for 12 months
• Brimica
As per product specifications
• Duaklir
As per product specifications
• Ultibro
As per product specifications
• Ulunar
As per product specifications
• Xoterna
As per product specifications
• Anoro
As per product specifications
• Laventair
As per product specifications
• Spiolto Respimat
As per product specifications
• Yanimo
As per product specifications
• Foradil
As per product specifications
• Broncoral
As per product specifications
• Formoterol stada
As per product specifications
• Oxis
As per product specifications
• Formatris
As per product specifications
• Formoterol Aldo
As per product specifications
• Onbrez
As per product specifications
• Oslif
As per product specifications
• Hirobriz
As per product specifications
• Striverdi
As per product specifications
• Beglan
As per product specifications
• Betamican
As per product specifications
• Inaspir
As per product specifications
• Serevent
As per product specifications
• Soltel
As per product specifications
• Eklira
As per product specifications
• Bretaris
As per product specifications
• Seebri
As per product specifications
• Tovanor
As per product specifications
• Enurev
As per product specifications
• Spiriva
As per product specifications
• Tavulus
As per product specifications
• Sirkava
As per product specifications
• Braltus
As per product specifications
• Gregal
As per product specifications
• Incruse
As per product specifications
• Rolufta
As per product specifications

Locations

Country	Name	City	State
Spain	Hospital Clínic Barcelona	Barcelona	Catalunya

Sponsors (2)

Lead Sponsor	Collaborator
Fundacio Privada Mon Clinic Barcelona	GlaxoSmithKline

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	3,6,9 and 12 months
Secondary	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).	3,6,9 and 12 months
Secondary	Patients persistently controlled	Patients persistently controlled (at all visits) throughout the study between the two study arms as per: CC - Stability Domain; General status since the last visit; Exacerbations in the last 3 months; CC - Impact Domain; Sputum color; Rescue medication use; Minutes walked per day; Dyspnea (mMRC); CID-CAT - Exacerbations; CID-CAT - (Patient reported outcomes)PROs; CID-CAT - Lung function	3,6,9 and 12 months
Secondary	Time to deterioration	time to first event of not being CC or suffer CID-CAT	3,6,9 and 12 months
Secondary	Time to no control event of CC - Stability Domain	Time to first no control event for CC - Stability Domain	3,6,9 and 12 months
Secondary	Time to no control event of CC - Impact Domain	Time to first no control event for CC - Impact Domain	3,6,9 and 12 months
Secondary	Time to deterioration event of CID-CAT Exacerbations	Time to deterioration event for CID-CAT Exacerbations	3,6,9 and 12 months
Secondary	Time to deterioration event of CID-CAT Spirometry	Time to deterioration event for CID-CAT Spirometry	3,6,9 and 12 months
Secondary	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	3,6,9 and 12 months
Secondary	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	3,6,9 and 12 months
Secondary	Spirometry changes	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
Secondary	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.	3,6,9 and 12 months