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Completed

NCT Number: NCT01750658

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

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

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitari Son Espases

Palma de Mallorca, Balearic Islands, 07010, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Cimera

Network

Collaborators

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

Registry information

Official study title

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

Acronym: ECOS

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Dec 17, 2012
Registry last updated
Dec 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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