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

December 13, 2012 updated by: Cimera

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

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

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

99

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illes Balears
      • Palma de Mallorca, Illes Balears, Spain, 07010
        • Hospital Universitari Son Espases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

COPD patients admitted in any of the participating ECOS hospitals with a diagnosis of COPD exacerbation

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
COPD

COPD patients admitted in any of the participating ECOS hospitals due to a COPD exacerbation.

  1. - 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.
  2. - Endogenous factors. These factors (hyperinflation, pulmonary embolism, cardiac dysfunction, mucus hypersecretion) are present in a proportion higher than expected
  3. - 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

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

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
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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

November 14, 2012

First Submitted That Met QC Criteria

December 13, 2012

First Posted (Estimate)

December 17, 2012

Study Record Updates

Last Update Posted (Estimate)

December 17, 2012

Last Update Submitted That Met QC Criteria

December 13, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

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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