Study of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations In Spain (ECOS)
|ClinicalTrials.gov Identifier: NCT01750658|
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : December 17, 2012
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||99 participants|
|Official Title:||ECOS: A Study of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations In Spain (o Estudio de Las Exacerbaciones de la EPOC en España)|
|Study Start Date :||September 2006|
|Primary Completion Date :||December 2009|
|Study Completion Date :||December 2009|
COPD patients admitted in any of the participating ECOS hospitals due to a COPD exacerbation.
- Time to new COPD exacerbation [ Time Frame: 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.
- Characterization and severity of pulmonary and systemic inflammation [ Time Frame: 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 [ Time Frame: 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
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750658
|Hospital Universitari Son Espases|
|Palma de Mallorca, Illes Balears, Spain, 07010|