Clinical Trials Directory

Trials / Completed

CompletedNCT01750658

Study of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations In Spain

ECOS: A Study of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations In Spain (o Estudio de Las Exacerbaciones de la EPOC en España)

Status
Completed
Phase
Study type
Observational
Enrollment
99 (actual)
Sponsor
Cimera · Network
Sex
All
Age
40 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2006-09-01
Primary completion
2009-12-01
Completion
2009-12-01
First posted
2012-12-17
Last updated
2012-12-17

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT01750658. Inclusion in this directory is not an endorsement.