COPD ExacerbationNCT06147206
Exacerbantes Study
An observational study of COPD Exacerbation, run by Sociedad Española de Neumología y Cirugía Torácica.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD Exacerbation
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2023to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: "ANTES" Proposal: A New Approach to Exacerbation in COPD Patients. Exacerbantes Study.
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.
Read more
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.
Read the 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
- Keywords
- COPD, Exacerbation, Personalized medicine, Treatable traits
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start31 Dec 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Juan José Soler Cataluna, MD, Sociedad Española de Neumología y Cirugía Torácica
- Investigators
- Juan José Soler-Cataluña, MD, Principal investigator, Hospital Arnau de Vilanova (Valencia); Valencia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147206
- Sponsor's protocol ID
- NEM_EPOC_2023.1
- Status last verified
- Nov 2023
- First submitted
- 19 Nov 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34570991Soler-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.
PubMed 34172340Jose 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.
PubMed 36780913Soler-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.
PubMed 32893033
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "ANTES" Proposal: A New Approach to Exacerbation in COPD Patients. Exacerbantes Study.
- ClinicalTrials.gov ID
- NCT06147206
- Acronym / sponsor ID
- NEM_EPOC_2023.1
- Conditions
- COPD Exacerbation
- Keywords
- COPD, Exacerbation, Personalized medicine, Treatable traits
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 31 Dec 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 27 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To describe treatable traits (TTs) distribution in AECOPD
Time frame: Acute presentation of clinical worsening (less than 14 days)
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
6 secondary outcomes
To evaluate the relationship of the different RTs with the following outcomes: relapse, recurrence, major adverse cardiovascular event (MACE) and mortality
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.
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
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
Time frame: 90 days
To assess the feasibility of FEV1 measurement by using a micro spirometer during COPD decompensation
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
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Background: PubMed 34570991Celli 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.
- Background: PubMed 34172340Soler-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.
- Background: PubMed 36780913Jose 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.
- Background: PubMed 32893033Soler-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan José Soler-Cataluña, MD principal investigator
Hospital Arnau de Vilanova (Valencia); Valencia University
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Exacerbation, run by Sociedad Española de Neumología y Cirugía Torácica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan José Soler-Cataluña, MD (+34 629821697, jjsoler@telefonica.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe treatable traits (TTs) distribution in AECOPD (time frame: Acute presentation of clinical worsening (less than 14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06147206, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.