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

Sponsor

Cimera (Other)

Overall Status

Completed

CT.gov ID

NCT01750658

Collaborator

Hospital Son Espases (Other), HOSPITAL DOCE DE OCTUBRE (Other), Hospital Clinic of Barcelona (Other), Germans Trias i Pujol Hospital (Other), Hospital Universitario Fundación Jiménez Díaz (Other), HOSPITAL LA FE VALENCIA (Other), Hospital de Galdakao (Other), Hospital del Mar (Other)

Enrollment

Location

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

ECOS is a cross-sectional, observational, longitudinal, multicenter study enrolling 100-200 patients during a COPD exacerbation.

Condition or Disease	Intervention/Treatment	Phase
COPD

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 Design

Study Type:

Observational

Actual Enrollment :

99 participants

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)

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
COPD COPD patients admitted in any of the participating ECOS hospitals due to a COPD exacerbation. - External factors. The episodes of COPD exacerbations are associated to exogenous factors (pollution, change of ambient temperature, humidity, infections). The prevalence of environmental contamination and infections is higher than expected. - Endogenous factors. These factors (hyperinflation, pulmonary embolism, cardiac dysfunction, mucus hypersecretion) are present in a proportion higher than expected - During exacerbations of COPD serum markers of inflammation and autoimmunity are high relative to baseline in COPD and decrease progressively during the follow-up, after controlling the acute episode

Arm

Intervention/Treatment

COPD

COPD patients admitted in any of the participating ECOS hospitals due to a COPD exacerbation. - External factors. The episodes of COPD exacerbations are associated to exogenous factors (pollution, change of ambient temperature, humidity, infections). The prevalence of environmental contamination and infections is higher than expected. - Endogenous factors. These factors (hyperinflation, pulmonary embolism, cardiac dysfunction, mucus hypersecretion) are present in a proportion higher than expected - During exacerbations of COPD serum markers of inflammation and autoimmunity are high relative to baseline in COPD and decrease progressively during the follow-up, after controlling the acute episode

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitari Son Espases	Palma de Mallorca	Illes Balears	Spain	07010

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cimera

ClinicalTrials.gov Identifier:

NCT01750658

Other Study ID Numbers:

Nº IB 497/05

First Posted:

Dec 17, 2012

Last Update Posted:

Dec 17, 2012

Last Verified:

Dec 1, 2012

Keywords provided by Cimera

Biomarkers

Exacerbations