COPD
Conditions
Keywords
Biomarkers, Exacerbations, COPD
Brief summary
ECOS is a cross-sectional, observational, longitudinal, multicenter study enrolling 100-200 patients during a COPD exacerbation.
Detailed description
Patients will be followed for 12 months. Information to be collected includes clinical, analytical, immunological, microbiological, hemodynamic, imaging, environmental, social and other blood markers of inflammation (IL-8, IL-6, TNF, TNF-alpha, endothelin-1, SLPI, IL10, TGF-beta and markers oxidative stress (TEAC)), and sputum (cell count, IL-6, IL-8, SLPI, ET 1, IL10). Each center will collect clinical data, blood gas, microbiological and functional data for their patients, which will be centralized through the website of the Red Respira (www.redrespira.net). A frozen serum sample and another of frozen sputum supernatant will be sent to the coordinating center (Palma de Mallorca). Statistical analysis will include descriptive statistics: mean, standard deviation and range. Comparison of quantitative variables to be assessed using Student's t-test and ANOVA. Correlations between variables will be performed using bivariate analyzes (Pearson's linear correlation coefficient) and multivariate (multiple regression) analyses, among others.
Interventions
None listed
Sponsors
Hospital Son Espases
HOSPITAL DOCE DE OCTUBRE
Hospital Clinic of Barcelona
Germans Trias i Pujol Hospital
Hospital Universitario Fundación Jiménez Díaz
Hospital La Fe de Valencia
Hospital de Galdakao
Hospital del Mar
Cimera
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Men and women * Ages 40-80 years * Diagnosis of COPD (according to ATS/ERS consensus guidelines) * Smoking history ≥ 10 pack years * Hospitalization for exacerbation of COPD
Exclusion criteria
* Pneumonia. * Pneumothorax. * Severe comorbidities, such as: * -Advanced cancer. * -Pulmonary tuberculosis, which affects more than one third of the total lung parenchyma. * -Pneumonectomy. * -Previous diagnosis of left heart failure. * -Cardiomyopathy with ventricular dysfunction (ejection fraction \<45%). * -Chronic inflammatory diseases such as asthma, rheumatoid arthritis, pulmonary fibrosis and autoimmune diseases. * Mechanical Ventilation. * Existence of an exacerbation of COPD in the 4 weeks prior to admission. * MRSA. * History of thoracic/lung surgery in the past two years * General weakness/malaise (difficulty in walking, lack of autonomy, etc.). that substantially hinders participation in the study, regardless of their willingness to participate. * Mental incapacity according to the investigator judgment. * Not resident in the province in which the hospital is located. * Not fluent in Spanish * Allergy to iodinated contrast * Morbid obesity (BMI\> 40)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to new COPD exacerbation | One year | From discharge of the current hospitalization, the time to a new COPD exacerbation will be estimated. The final aim of this study, descriptive, exploratory and hypothesis-generating, is to obtain a better understanding of the pathobiology of COPD exacerbations to eventually identify clinical correlations (biomarkers) that can help identify and diagnose them more accurately, and guide clinical practice for a more efficient way. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Characterization and severity of pulmonary and systemic inflammation | One year | Describe the biological characterization and severity of pulmonary and systemic inflammation, by means of presence/absence of inflamatory markers, their combination and their concentrations |
| Paired, Individual changes in pulmonary and systemic inflammation | One year | Within individuals, characterization and severity of pulmonary and systemic inflammation, by means of presence/absence of inflamatory markers, their combination and their concentrations |
Countries
Spain
Outcome results
None listed