Study of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations In Spain (ECOS)
ECOS is a cross-sectional, observational, longitudinal, multicenter study enrolling 100-200 patients during a COPD exacerbation.
|Study Design:||Observational Model: Case-Crossover
Time Perspective: Prospective
|Official Title:||ECOS: A Study of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations In Spain (o Estudio de Las Exacerbaciones de la EPOC en España)|
- Time to new COPD exacerbation [ Time Frame: One year ] [ Designated as safety issue: No ]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.
- Characterization and severity of pulmonary and systemic inflammation [ Time Frame: One year ] [ Designated as safety issue: No ]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 [ Time Frame: One year ] [ Designated as safety issue: No ]Within individuals, characterization and severity of pulmonary and systemic inflammation, by means of presence/absence of inflamatory markers, their combination and their concentrations
Biospecimen Retention: Samples Without DNA
|Study Start Date:||September 2006|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
COPD patients admitted in any of the participating ECOS hospitals due to a COPD exacerbation.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750658
|Hospital Universitari Son Espases|
|Palma de Mallorca, Illes Balears, Spain, 07010|