COPD Exacerbation Clinical Trial
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. 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.
Status | Not yet recruiting |
Enrollment | 400 |
Est. completion date | March 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sociedad Española de Neumología y Cirugía Torácica | GlaxoSmithKline |
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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | 90 days of follow-up | |
Secondary | 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 | 90 days | |
Secondary | 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 | 90 days | |
Secondary | 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. | 90 days | |
Secondary | 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 | During the first attendance of AECOPD (hours) | |
Secondary | 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 | 90 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT06000696 -
Healthy at Home Pilot
|
||
Recruiting |
NCT03250000 -
Changes in Microcirculation and Functional Status During Exacerbation of COPD
|
N/A | |
Recruiting |
NCT04142827 -
The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX)
|
N/A | |
Recruiting |
NCT05865184 -
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
|
||
Completed |
NCT01892566 -
Using Mobile Health to Respond Early to Acute Exacerbations of COPD in HIV
|
N/A | |
Completed |
NCT04119856 -
Outgoing Lung Team - a Cross-sectorial Intervention in Patients With COPD
|
N/A | |
Recruiting |
NCT06118632 -
Physiological and Environmental Data in a Remote Setting to Predict Exacerbation Events in Patients With Chronic Obstructive Pulmonary Disease
|
||
Recruiting |
NCT04860375 -
Multidisciplinary Management of Severe COPD
|
N/A | |
Completed |
NCT04170361 -
The Effect of Incentive Spirometry Added to Routine Physiotherapy Program on Hemodynamic Responses and Hospital Stay in Patients With COPD Exacerbation
|
N/A | |
Not yet recruiting |
NCT03696563 -
FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS
|
N/A | |
Not yet recruiting |
NCT03296215 -
Pattern of Admitted Cases in Respiratory Intensive Care Unit at Assiut University Hospitals
|
N/A | |
Completed |
NCT02912689 -
NIV - NAVA vs NIV - PS for COPD Exacerbation
|
N/A | |
Completed |
NCT03003702 -
Domiciliary Monitoring to Predict Exacerbations of COPD
|
N/A | |
Recruiting |
NCT02264483 -
Low-dose CT for Diagnosis of Pneumonia in COPD Exacerbations and Comparison of the Inflammatory Profile.
|
N/A | |
Completed |
NCT01443845 -
Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)
|
Phase 4 | |
Recruiting |
NCT02065921 -
Swiss Chronic Obstructive Pulmonary Disease (COPD) Management Cohort
|
||
Completed |
NCT04880486 -
Weight Training With VR in Out-Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
|
N/A | |
Recruiting |
NCT03286127 -
Palliative Outcome Evaluation Muenster I
|
||
Recruiting |
NCT04638920 -
Molecular Breath Print of COPD Patients With Exacerbations Despite Triple Inhalational Therapy
|
||
Not yet recruiting |
NCT05897125 -
Telehealth Education Leveraging Electronic Transitions Of Care for COPD Patients
|
N/A |