Exacerbantes Study
"ANTES" Proposal: A New Approach to Exacerbation in COPD Patients. Exacerbantes Study.
"ANTES" Proposal: A New Approach to Exacerbation in COPD Patients. Exacerbantes Study.
Sponsor study identifier
observational
400
0 countries
N/A
Study Start
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2024
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Study Completion
March 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is understood as a complex and heterogeneous syndrome, which requires an increasingly personalized approach. A new approach to AECOPD recognized that several etiopathogenic mechanisms can lead to a worsening ot the patients. This new approach is based on the identification of different treatable traits (TTs). The goal of this observational study is to describe how TTs are distributed in patients with AECOPD in primary care (PC) and hospital emergencies department (HED) to address their complexity and heterogeneity. As a secondary outcomes we also try to evaluate the relationship of TTs with relevant clinical outcomes (relapse, recurrence, MACE (Major Adverse Cardiovascular Event) and all-cause mortality) and create a risk score and compare this new severity score with Rome and GesEPOC proposals. In the AP group, a series of basic tests for routine use will be systematically performed, among which chest x-ray, electrocardiogram and other new tests such as microspirometry (COPD-6) and a point of care determination of capillary C-reactive protein (CRP). In the HED group routine determinations will be expanded to include blood tests, arterial blood gases and biomarkers (CRP, TnT, NT-proBNP and D-Dimer). Patients will be re-evaluated 90 days after the initial episode, to evaluate different clinical outcomes. The estimated sample size is 400 patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 19, 2023
Actual (reported)November 27, 2023
Actual (reported)December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To describe treatable traits (TTs) distribution in AECOPD
A treatable trait is defined as a clinical, functional or biological features, which can be identified through the use of diagnostic tests or biomarkers, and which have a specific treatment
Acute presentation of clinical worsening (less than 14 days)
To evaluate the relationship of the different RTs with the following outcomes: relapse, recurrence, major adverse cardiovascular event (MACE) and mortality
90 days of follow-up
To explore the creation of a predictive risk score (recurrence/ readmission/mortality/MACE) based on the patient-focused approach from the ANTES proposal in both PC and hospital emergency settings.
90 days
To compare the predictive capacity of the risk score generated from the ANTES proposal, with the Rome and GesEPOC severity scores
90 days
In the subgroup of patients seen in hospital, compare the 3 risk score proposals (ANTES, Roma and GesEPOC) with the DECAF score
90 days
To assess the feasibility of FEV1 measurement by using a micro spirometer during COPD decompensation
During the first attendance of AECOPD (hours)
COPD patients managed for worsening respiratory symptoms of any origin, both in primary care (PC group) and in the hospital emergency department (HED group) will be included.
Celli BR, Fabbri LM, Aaron SD, Agusti A, Brook R, Criner GJ, Franssen FME, Humbert M, Hurst JR, O'Donnell D, Pantoni L, Papi A, Rodriguez-Roisin R, Sethi S, Torres A, Vogelmeier CF, Wedzicha JA. An Updated Definition and Severity Classification of Chronic Obstructive Pulmonary Disease Exacerbations: The Rome Proposal. Am J Respir Crit Care Med. 2021 Dec 1;204(11):1251-1258. doi: 10.1164/rccm.202108-1819PP. No abstract available.
Soler-Cataluna JJ, Pinera P, Trigueros JA, Calle M, Casanova C, Cosio BG, Lopez-Campos JL, Molina J, Almagro P, Gomez JT, Riesco JA, Simonet P, Rigau D, Soriano JB, Ancochea J, Miravitlles M; en representacion del grupo de trabajo de GesEPOC 2021. Spanish COPD Guidelines (GesEPOC) 2021 Update Diagnosis and Treatment of COPD Exacerbation Syndrome. Arch Bronconeumol. 2022 Feb;58(2):159-170. doi: 10.1016/j.arbres.2021.05.011. Epub 2021 May 26. English, Spanish.
Blood sample to assess several biomarkers (CRP, NT-proBNP, Troponin) in hospital emergence treated population. Only capillary CRP in the primary care treated population.
Juan José Soler-Cataluña, MD
Hospital Arnau de Vilanova (Valencia); Valencia University
First Submitted
November 19, 2023
First Posted
November 27, 2023
Study Start
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2024
Once Daily Long-Acting Muscarinic Antagonists Administered in the Evening for Prevention of Chronic Obstructive Pulmonary Disease Exacerbations Requiring Hospitalization or Death from Any Cause
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Jose Soler-Cataluna J, Miravitlles M, Fernandez-Villar A, Izquierdo JL, Garcia-Rivero JL, Cosio BG, Lopez-Campos JL, Agusti A; ANTES panellists. Exacerbations in COPD: a personalised approach to care. Lancet Respir Med. 2023 Mar;11(3):224-226. doi: 10.1016/S2213-2600(22)00533-1. Epub 2023 Feb 10. No abstract available.
Soler-Cataluna JJ, Miralles C. Exacerbation Syndrome in COPD: A Paradigm Shift. Arch Bronconeumol (Engl Ed). 2021 Apr;57(4):246-248. doi: 10.1016/j.arbres.2020.07.008. Epub 2020 Sep 4. No abstract available. English, Spanish.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 27, 2023
Record last verified: 2023-11
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