Exacerbantes Study

NCT06147206 | Unknown

• 1 other identifier: NEM_EPOC_2023.1
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

COPD Exacerbation

Keywords

COPD; Exacerbation; Personalized medicine; Treatable traits

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (6)

• 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)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Men or women who request emergency care (primary care or hospital) due to acute worsening of respiratory symptoms (of any nature)
• Age 40 years or older.
• Smokers or ex-smokers of \> 10 pack-years
• Expiratory airflow limitation, documented by any of the following methods:
• Post bronchodilation FEV1/FVC \< 0.7, in a previous forced spirometry, or
• FEV1/FEV6 less than 0.73 on microspirometry performed during decompensation

You may not qualify if:

• Patients with active neoplasia in the last 3 years.
• Associated pleural effusion susceptible to thoracentesis.
• Pneumothorax.
• Thoracic trauma.
• Impossibility of subsequent follow-up (3 months).

Sponsors & Collaborators

• Sociedad Española de Neumología y Cirugía Torácica: lead
• GlaxoSmithKline: collaborator

Related Publications (4)

• 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.

  PMID: 34570991 BACKGROUND

• 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.

  PMID: 34172340 BACKGROUND

• 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.

  PMID: 36780913 BACKGROUND

• 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.

  PMID: 32893033 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample to assess several biomarkers (CRP, NT-proBNP, Troponin) in hospital emergence treated population. Only capillary CRP in the primary care treated population.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan José Soler-Cataluña, MD

  Hospital Arnau de Vilanova (Valencia); Valencia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan José Soler-Cataluña, MD

CONTACT

+34 629821697; jjsoler@telefonica.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pneumologist

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: November 27, 2023
• Study Start: December 31, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share