- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01750658
Study of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations In Spain (ECOS)
ECOS: A Study of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations In Spain (o Estudio de Las Exacerbaciones de la EPOC en España)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Illes Balears
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Palma de Mallorca, Illes Balears, Spain, 07010
- Hospital Universitari Son Espases
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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COPD
COPD patients admitted in any of the participating ECOS hospitals due to a COPD exacerbation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
One year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
One year
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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
|
One year
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nº IB 497/05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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