Clinical trial NCT06147206: Exacerbantes Study
Official title: "ANTES" Proposal: A New Approach to Exacerbation in COPD Patients. Exacerbantes Study.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: COPD Exacerbation
Keywords: COPD
Exacerbation
Personalized medicine
Treatable traits
Lead sponsor: Sociedad Española de Neumología y Cirugía Torácica
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2023-11-27
Enrollment: 400
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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).

Primary outcomes:
measure: To describe treatable traits (TTs) distribution in AECOPD
timeFrame: Acute presentation of clinical worsening (less than 14 days)
Secondary outcomes:
measure: To evaluate the relationship of the different RTs with the following outcomes: relapse, recurrence, major adverse cardiovascular event (MACE) and mortality
timeFrame: 90 days of follow-up
measure: 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.
timeFrame: 90 days
measure: To compare the predictive capacity of the risk score generated from the ANTES proposal, with the Rome and GesEPOC severity scores
timeFrame: 90 days
measure: In the subgroup of patients seen in hospital, compare the 3 risk score proposals (ANTES, Roma and GesEPOC) with the DECAF score
timeFrame: 90 days
measure: To assess the feasibility of FEV1 measurement by using a micro spirometer during COPD decompensation
timeFrame: During the first attendance of AECOPD (hours)
measure: 6. To compare the lung function evaluated during COPD decompensation with that obtained after recovery, 90 days after the index event
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Arnau de Vilanova (Valencia); Valencia University
name: Juan José Soler-Cataluña, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.