An observational study in COPD Exacerbation, sponsored by Sociedad Española de Neumología y Cirugía Torácica. Not yet recruiting. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2023-11-27.
Sponsored by Sociedad Española de Neumología y Cirugía Torácica · Observational
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.
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:
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.
Sociedad Española de Neumología y Cirugía Torácica is the lead sponsor of 42 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Expiratory airflow limitation, documented by any of the following methods:
Exclusion Criteria:
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
Time frame: 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
Relapse: appearance of a new worsening of symptoms within less than 4 weeks after the end of treatment for the index exacerbation; Recurrence: appearance of new worsening of symptoms beyond 4 weeks (during the 90 days of follow-up) after the end of treatment for the index exacerbation; • MACE (Major adverse cardiovascular event). The presence of at least one of the follow cardiovascular events in the 90 days after exacerbation index: acute myocardial infarct, unstable angor, revascularization, heart failure, stroke or cardiovascular mortality; Mortality: all-cause mortality in the 90 days of follow-up
Time frame: 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.
Risk score of severity
Time frame: 90 days
To compare the predictive capacity of the risk score generated from the ANTES proposal, with the Rome and GesEPOC severity scores
Rome and GesEPOC has a severity classification that will be compared with the new risk score created from ANTES proposal
Time frame: 90 days
In the subgroup of patients seen in hospital, compare the 3 risk score proposals (ANTES, Roma and GesEPOC) with the DECAF score
All 3 severity classifications will be compared with DECAF validated score, but only in those patients treated at hospital emergency room.
Time frame: 90 days
To assess the feasibility of FEV1 measurement by using a micro spirometer during COPD decompensation
Evaluate if FEV1 can be assessed during the AECOPD using COPD-6 microspirometer
Time frame: During the first attendance of AECOPD (hours)
6. To compare the lung function evaluated during COPD decompensation with that obtained after recovery, 90 days after the index event
Compared FEV1 values during AECOPD and stable phase 90 days after
Time frame: 90 days
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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