Exacerbantes Study

NCT ID: NCT06147206

Last Updated: 2023-11-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2025-03-31

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.

Detailed Description

Justification COPD exacerbations (AECOPD) are heterogeneous and complex in nature, demanding an increasingly personalized approach. Recently, the ANTES proposal was presented, a patient-centered approach based on the treatable traits (TT) strategy. Other recent initiatives, such as the Rome proposal or GesEPOC, also propose new definitions and ways to classify the severity of AECOPD. However, none of these 3 new proposals have been validated.

Objectives:

• Main: Describe in a systematic way how the different TTs are distributed in patients with AECOPD in primary care (PC) and hospital emergencies department (HED).
• Secondary: (1) evaluate the relationship of the different treatable features with the following clinical outcomes: relapse, recurrence, MACE (Major Adverse Cardiovascular Event) and all-cause mortality; (2) create a risk scale for recurrence, readmission, MACE and/or mortality, both in PC and HED; (3) compare the predictive capacity of the risk scale generated from the ANTES proposal, with the Rome and GesEPOC severity scales; (4): in the subgroup of patients treated in the hospital, compare the 3 risk scales (ANTES, Roma and GesEPOC) with the valid DECAF scale (5); assess whether it is feasible to determine FEV1, through the use of microspirometers, during COPD decompensation; and (6) compare lung function evaluated during decompensation with that obtained after recovery, 90 days after the index event.

Material:

Prospective, multicenter, longitudinal, observational study on patients diagnosed with AECOPD in PC and HED. In the AP cohort, 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 determination of point of care capillary C-reactive protein (CRP). In the HED cohort, 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 (relapse, recurrence, MACE and mortality). The distribution of different TTs will be analyzed and a new predictive risk scale will be created from them, comparing it with the Rome and GesEPOC scales. The estimated sample size is 400 patients.

Conditions

COPD Exacerbation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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).

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Sociedad Española de Neumología y Cirugía Torácica

OTHER

Sponsor Role: lead

Responsible Party

Juan José Soler Cataluna, MD

Pneumologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan José Soler-Cataluña, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Arnau de Vilanova (Valencia); Valencia University

Central Contacts

Juan José Soler-Cataluña, MD

Role: CONTACT

jjsoler@telefonica.net

+34 629821697

References

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.

Reference Type: BACKGROUND

PMID: 34570991 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34172340 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36780913 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32893033 (View on PubMed)

Other Identifiers

NEM_EPOC_2023.1

Identifier Type: -

Identifier Source: org_study_id